anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Fenebrutinib
Trial phase: Phase 2
SMILES: C[C@H]1CN(C2COC2)CCN1c1ccc(Nc2cc(-c3ccnc(N4CCn5c(cc6c5CC(C)(C)C6)C4=O)c3CO)cn(C)c2=O)nc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 410
Group description: Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.
Eligibility criteria:
Inclusion Criteria:

Completion of treatment as specified in Study GA29350, including completion of the Day 84 study visit assessments
Acceptable safety and tolerability during Study GA29350 as determined by the investigator or Medical Monitor
Have not received any prohibited medications in Study GA29350
While taking methotrexate, must be willing to receive oral folic acid (at least 5 milligrams per week [mg/week])
If receiving oral corticosteroids (less than or equal to [</=] 10 milligrams per day [mg/day] prednisone or equivalent) and/or non-steroidal anti-inflammatory drugs, doses have remained stable for the duration of Study GA29350

Exclusion Criteria:

Met protocol defined treatment stopping criteria during Study GA29350
Treatment with any investigational agent (i.e., other than study drug) or live/attenuated vaccine or any other prohibited medication during Study GA29350 or since the last administration of study drug in Study GA29350
In the opinion of the investigator, any new (since initially enrolling in the Phase II Study GA29350), significant, uncontrolled comorbidity that would increase the risk to the participant in Study GA30067
Pregnant or lactating, or intending to become pregnant during the study
Participants who experienced a de novo or reactivated serious viral infection such as hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) during the Phase II Study GA29350
Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics during the Phase II Study GA29350
Participants who developed a malignancy during the Phase II Study GA29350
12-lead electrocardiogram (ECG) on Day 84 in Study GA29350 that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
Current treatment with medications that are well known to prolong the QT interval
Intervention: Fenebrutinib
Trial phase: Phase 2
SMILES: C[C@H]1CN(C2COC2)CCN1c1ccc(Nc2cc(-c3ccnc(N4CCn5c(cc6c5CC(C)(C)C6)C4=O)c3CO)cn(C)c2=O)nc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 86
Group description: Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
Eligibility criteria:
Inclusion Criteria:

Completion of treatment as specified in Study GA29350, including completion of the Day 84 study visit assessments
Acceptable safety and tolerability during Study GA29350 as determined by the investigator or Medical Monitor
Have not received any prohibited medications in Study GA29350
While taking methotrexate, must be willing to receive oral folic acid (at least 5 milligrams per week [mg/week])
If receiving oral corticosteroids (less than or equal to [</=] 10 milligrams per day [mg/day] prednisone or equivalent) and/or non-steroidal anti-inflammatory drugs, doses have remained stable for the duration of Study GA29350

Exclusion Criteria:

Met protocol defined treatment stopping criteria during Study GA29350
Treatment with any investigational agent (i.e., other than study drug) or live/attenuated vaccine or any other prohibited medication during Study GA29350 or since the last administration of study drug in Study GA29350
In the opinion of the investigator, any new (since initially enrolling in the Phase II Study GA29350), significant, uncontrolled comorbidity that would increase the risk to the participant in Study GA30067
Pregnant or lactating, or intending to become pregnant during the study
Participants who experienced a de novo or reactivated serious viral infection such as hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) during the Phase II Study GA29350
Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics during the Phase II Study GA29350
Participants who developed a malignancy during the Phase II Study GA29350
12-lead electrocardiogram (ECG) on Day 84 in Study GA29350 that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
Current treatment with medications that are well known to prolong the QT interval
Intervention: Desoximetasone
Trial phase: Phase 4
ATC code: D07AC03 | D07XC02
SMILES: [H][C@@]12CCC3=CC(=O)C=C[C@]3(C)[C@@]1(F)[C@@H](O)C[C@]1(C)[C@@H](C(=O)CO)[C@H](C)C[C@@]21[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Topicort topical spray

Topicort Topical Spray: open label Topicort spray
Eligibility criteria:
Inclusion Criteria:

Male or female adults ≥ 18 years of age.
Diagnosis of chronic plaque-type psoriasis.
Able to give written informed consent prior to performance of any study related procedures.
Treated with a biologic agent for a minimum of 24 weeks at baseline.
Plaque-type psoriasis as defined at screening and baseline by BSA ≤ 5%.
Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide.
Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination.

Exclusion Criteria:

>5% Body Surface Area
Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study.
Pregnant or breast feeding, or considering becoming pregnant during the study.

Malignancy or history of malignancy, except for:

treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;
treated [ie, cured] malignancy with no evidence of recurrence within the previous 5 years.
Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
Use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin, apremilast and cyclosporine).
Patient used other topical therapies to treat within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids).
Patient received UVB phototherapy within 2 weeks of Baseline.
Patient received PUVA phototherapy within 4 weeks of Baseline.
Patient has a known hypersensitivity to the excipients of Topicort Spray® as stated in the label.
Intervention: Dapagliflozin
Trial phase: Phase 3
ATC code: A10BD15 | A10BD21 | A10BD25 | A10BK01
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](CO)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: 20 subjects will receive dapagliflozin 10mg

Dapagliflozin: Three 5-hour measurements (after dapagliflozin 10mg administration) of endogenous glucose production (EGP) will be performed on separate days.
Eligibility criteria:
Inclusion Criteria:

T2DM according to ADA criteria-HbA1C < 8.0%
BMI = 25-35 kg/m2
Subjects must be in good general health as determined by physical exam, medical history, blood chemistries, CBC, TSH, T4, EKG and urinanalysis
Body weight has been stable (± 3 lbs) over the preceding three months
Do not participate in an excessively heavy exercise program
Taking stable dose (more than 3 months) of monotherapy or combination therapy with metformin and/or a sulfonylurea

Exclusion Criteria:

Subjects taking drugs known to affect glucose metabolism (other than metformin and sulfonylurea) will be excluded
Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine >1.4 females or >1.5 males, or 24-hour urine albumin excretion > 300 mg will be excluded
Intervention: Desoximetasone
Trial phase: Phase 4
ATC code: D07AC03 | D07XC02
SMILES: [H][C@@]12CCC3=CC(=O)C=C[C@]3(C)[C@@]1(F)[C@@H](O)C[C@]1(C)[C@@H](C(=O)CO)[C@H](C)C[C@@]21[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Topicort Topical Spray applied BID for 4 weeks followed by BID on 2 consecutive days through week 16
Eligibility criteria:
Inclusion Criteria:

Male or female adults ≥ 18 years of age.
Diagnosis of chronic plaque-type scalp psoriasis.
IGA of mild or greater (scalp only) determined at screening
Scalp surface area of 30% or greater determined at screening
Able to give written informed consent prior to performance of any study related procedures.
Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom, diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide.
Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination.

Exclusion Criteria:

<30% scalp surface area
Scalp Investigator global assessment (IGA) clear or almost clear at time of screening
Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study.
Pregnant or breast feeding, or considering becoming pregnant during the study.
Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
Use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin, apremilast and cyclosporine).
Use of ustekinumab and/or anti-IL-17 (interleukin 17) biologic therapy within 24 weeks or other experimental or commercially available biologic immune modulator(s) within 12 weeks prior to the first IP dose.
Patient used other topical therapies to treat within 2 weeks of the Baseline Visit (not including permitted topical therapy for face, groin and axilla).
Patient received ultraviolet B, UVB phototherapy within 2 weeks of Baseline.
Patient received psoralen and Ultraviolet A, PUVA phototherapy within 4 weeks of Baseline.
Patient has a known hypersensitivity to the excipients of Topicort Spray® as stated in the label.
Intervention: Ondansetron
Trial phase: Phase 4
ATC code: A04AA01
SMILES: Cc1nccn1CC1CCc2c(c3ccccc3n2C)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 127
Group description: Ondansetron (4 mg) followed by two 5 ml normal saline flush

Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes
Eligibility criteria:
Inclusion Criteria:

Chief Complaint of nausea or abdominal pain with nausea
Inability to tolerate oral nausea medication
Patients with a negative pregnancy test

Exclusion Criteria:

Patients younger than 18 years of age
Patient's chief complaint includes headache, chest pain, or dizziness
Patients with whom there are contraindications to using the studied medicine (allergies, known adrenal disease)
Blood sugar greater than 300
Non-English speaking subjects
Intervention: Insulin
Trial phase: Phase 1 | Phase 2
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(N)=O)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: Subjects will administer 20 I.U. of insulin in the nostrils using a ViaNaseTM controlled particle dispersion nasal device two times/day (BID) for 24 weeks.

Insulin: All patients will receive either insulin or placebo using the Vianase III N2B device during the first 24 weeks of the study.
Eligibility criteria:
Inclusion Criteria:

Meets 2010 criteria for MS
No relapse in past 3 months
At least mild cognitive impairment (based off of SDMT/PST score)
Capacity to learn and self-administer intranasal insulin/placebo, or presence of a caregiver with such capacity who is willing to do it for the duration of the trial
Untreated/on the same MS therapy for at least 6 months, with no anticipated change in the next year
Willing to prevent pregnancy during study if female of childbearing potential

Exclusion Criteria:

Current, active major depression
No tricyclic antidepressant or anticonvulsant (except carbamazepine, pregabalin or gabapentin) use within 6 weeks of screening; if on oxybutynin or tolterodine, on stable dose for > 6 months without plans for changing dose in next year
If taking selective serotonin (± norepinephrine) reuptake inhibitors, pregabalin, gabapentin, sympathomimetic, monoamine oxidase inhibitor, antipsychotic, amantadine, cholinesterase inhibitor, memantine, modafanil, armodafinil, or evening short-acting benzodiazepines, on stable dose for 6 weeks or greater
Pregnant or nursing
THC; illicit drug or alcohol abuse in past 3 months
History of diabetes mellitus or insulin resistance
Active liver disease, stage IV/V kidney disease or severe metabolic derangements
CNS disorder other than MS or headache
Intervention: Insulin
Trial phase: Phase 1 | Phase 2
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(N)=O)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Subjects will administer 10 I.U. of insulin in the nostrils using a ViaNaseTM controlled particle dispersion nasal device two times/day (BID) for 24 weeks.

Insulin: All patients will receive either insulin or placebo using the Vianase III N2B device during the first 24 weeks of the study.
Eligibility criteria:
Inclusion Criteria:

Meets 2010 criteria for MS
No relapse in past 3 months
At least mild cognitive impairment (based off of SDMT/PST score)
Capacity to learn and self-administer intranasal insulin/placebo, or presence of a caregiver with such capacity who is willing to do it for the duration of the trial
Untreated/on the same MS therapy for at least 6 months, with no anticipated change in the next year
Willing to prevent pregnancy during study if female of childbearing potential

Exclusion Criteria:

Current, active major depression
No tricyclic antidepressant or anticonvulsant (except carbamazepine, pregabalin or gabapentin) use within 6 weeks of screening; if on oxybutynin or tolterodine, on stable dose for > 6 months without plans for changing dose in next year
If taking selective serotonin (± norepinephrine) reuptake inhibitors, pregabalin, gabapentin, sympathomimetic, monoamine oxidase inhibitor, antipsychotic, amantadine, cholinesterase inhibitor, memantine, modafanil, armodafinil, or evening short-acting benzodiazepines, on stable dose for 6 weeks or greater
Pregnant or nursing
THC; illicit drug or alcohol abuse in past 3 months
History of diabetes mellitus or insulin resistance
Active liver disease, stage IV/V kidney disease or severe metabolic derangements
CNS disorder other than MS or headache
Intervention: ABX-464
Trial phase: Phase 1 | Phase 2
SMILES: FC(F)(F)Oc1ccc(Nc2ccc3cccc(Cl)c3n2)cc1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: ABX464, 50mg per Capsule One Capsule per day for 28 days

ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)
Eligibility criteria:
Inclusion criteria:

Males aged 18-65 years;
Subjects with adequate hematological and biochemical laboratory parameters
Subjects should be able and willing to comply with study visits and procedures as per protocol;
Subjects should understand, sign and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures being performed;
Subjects must agree to use in addition to the condom, a second highly effective method (one for the subject and one for the partner) of contraception (defined as per the Clinical Trials Facilitation and Coordination Group (CTFG) Guidance).

For HIV positive Subjects

Subjects with a positive HIV-1 serology at any time before the study entry.
Subjects treated for at least 12 months prior to screening with Dolutegravir or Raltegravir combined with either Tenofovir + Emtricitabine (TDF/FTC) or Abacavir + Lamivudine (ABC/3TC);
Subjects with HIV plasma viral load ≤ 50 copies/mL during the 6 months prior to screening with a maximum of 2 blips ≤ 1000 copies during this period;
Subjects' HIV-1 plasma viral load to be ≤ 100,000 copies/mL at any time beyond 6 months after the estimated date of primary infection;

Exclusion Criteria:

History of allergic disease, anaphylaxis or reactions likely to be triggered or exacerbated by any component of investigational products;
Acute or chronic infectious disease other than HIV infection (include but not limited to viral hepatitis such as hepatitis B, hepatitis C, active tuberculosis, active syphilis [i.e. currently treated].
Acute, chronic or history of clinically relevant pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable Central Nervous System (CNS) pathology, angina or cardiac arrhythmias, or any other clinically significant medical problems as determined by physical examination and/or laboratory screening tests and/or medical history;
Severe hepatic impairment;
Acute, chronic or history of immunodeficiency or autoimmune disease other than HIV infection;
Intervention: Daptomycin
Trial phase: Not Applicable
ATC code: J01XX09
SMILES: CCCCCCCCCC(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(N)=O)C(=O)NC(CC(=O)O)C(=O)NC1C(=O)NCC(=O)NC(CCCN)C(=O)NC(CC(=O)O)C(=O)NC(C)C(=O)NC(CC(=O)O)C(=O)NCC(=O)NC(CO)C(=O)NC(C(C)CC(=O)O)C(=O)NC(CC(=O)c2ccccc2N)C(=O)OC1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 134
Group description: One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.

personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine.
Eligibility criteria:
Inclusion Criteria:

children with obstructive sleep apnea syndrome undergoing elective T&A, ASA physical status I-II

Exclusion Criteria:

developmental delay cardiac and craniofacial abnormalities ASA classification III or more body mass index more than the 95th percentile for age
Intervention: Piperacillin/tazobactam
Trial phase: Phase 4
SMILES: CC1(Cn2ccnn2)C(C(=O)O)N2C(=O)CC2S1(=O)=O.CCN1CCN(C(=O)NC(C(=O)NC2C(=O)N3C2SC(C)(C)C3C(=O)O)c2ccccc2)C(=O)C1=O
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Subjects in the medical therapy arm will be treated with piperacillin/tazobactam for at least 24 hours. Ciprofloxacin/metronidazole will be used in penicillin-allergic patients. Subjects will be maintained on nothing by mouth with intravenous fluids for at least 12 hours. Subjects will be transitioned to oral antibiotics when their WBC is normal, they have a decrease in CRP by ≥ 15%, and they have been afebrile for 24 hours on IV antibiotics.

Piperacillin/Tazobactam: 24 hours of IV antibiotic administration
Eligibility criteria:
Inclusion Criteria:

first episode of appendicitis
Pain < 48 hours
White blood cell count < 18,000
temperature < 103º F
radiographic evidence of acute appendicitis on ultrasound or CT without evidence of perforation
appendiceal diameter < 11 mm
ability to take oral antibiotics

Exclusion Criteria:

Prior antibiotic treatment for appendicitis
presence of medical condition prohibiting surgical therapy
radiographic or clinical evidence of abscess or perforation
appendiceal mass, positive pregnancy test
other diagnosis equally as likely as appendicitis
pain for ≥ 48 hours, white blood cell count ≥ 18,000, temperature ≥ 103º F, or appendiceal diameter ≥ 11 mm
inability to take oral antibiotics.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 1
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 16
Group description: Infusion (6 hours) of Saline

Saline: Infusion of saline
Eligibility criteria:
Inclusion Criteria:

Informed consent in writing available.
Willing and able to comply with all requirements of the study.
Male, 18 and 45 years (inclusive).
Subject has a body weight between 60 kg and 100 kg, extremes included.
BMI 18 to 27 kg/m2.
Non-smoker
Serum creatinine within reference range (≤1.2 mg/dL) and Cockroft-Gault Clearance > 90 ml/min
Good general health as judged by the Investigator, as determined by medical history, physical examination, vital signs (systolic and diastolic blood pressure and pulse rate) and clinical laboratory parameters (clinical chemistry, hematology, and urinalysis)

Exclusion Criteria:

Clinically significant abnormalities in physical examination, vital signs or clinical laboratory parameters (according to the Investigator's judgment).
Serum glutamate oxaloacetate transaminase or glutamate-pyruvate transaminase > 2-times above the upper limit of normal range.
Subject with Cockcroft-Gault clearance < 90 ml/min.
Clinically significant history of cardiovascular disease or any known present cardiovascular disease.
History of clinically significant neurological, gastrointestinal, renal, hepatic, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorders.
Office blood pressure at screening higher than 160/100 mmHg, or lower than 95/55 mmHg.
Office heart rate at screening after at least 5 minutes outside the range of 50- 99 beats per minute (inclusive).
Concomitant use of OTC medication within 1 week prior to dosing, except use of paracetamol (up to 2 g/day).
Participation in any other clinical study within 30 days prior to inclusion in this -