bioihbjkbjnl/mcl2 huggingface dataset:
Fasted Pharmacokinetic and Bioequivalency Study of Fenofibric Acid
Condition: Healthy
Intervention: Fenofibric Acid 35 mg Tablet; Fenofibric Acid 35 mg Tablet; Fenofibric Acid 105 mg Tablet
Intervention description: 1 x 35 mg tablet administered after an overnight fast of at least 10 hours; 3 x 35 mg tablets administered after an overnight fast of at least 10 hours; 105 mg tablet administered after an overnight fast of at least 10 hours
Intervention MeSH terms: Fenofibric acid; Fenofibrate
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: healthy; pharmacokinetics; therapeutic equivalency; fenofibric acid

Summary:

      This study will evaluate the pharmacokinetic linearity of a single 35 mg fenofibric acid dose
      and demonstrate the bioequivalence of three 35 mg fenofibric acid tablets (105 mg total
      single dose) to a single 105 mg fenofibric acid tablet in healthy adult volunteers when each
      dose is administered under fasted conditions. Safety and tolerability of these regimens will
      also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults 18-45 years of age

          -  Non-smoking

          -  Non-pregnant (post-menopausal, surgically sterile or using effective contraceptive
             measures)

          -  Body mass index (BMI) less than 30

          -  Medically healthy on the basis of medical history and physical examination

          -  Hemoglobin > or = to 12g/dL

          -  Completion of the screening process within 28 days prior to dosing

          -  Provision of voluntary written informed consent

        Exclusion Criteria:

          -  Recent participation (within 28 days) in other research studies

          -  Recent significant blood donation or plasma donation

          -  Pregnant or lactating

          -  Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface
             antigen (HbsAg), or hepatitis C virus (HCV)

          -  Recent (2-year) history or evidence of alcoholism or drug abuse

          -  History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or
             biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic,
             dermatologic, neurologic, or psychiatric disease

          -  Subjects who have used any drugs or substances known to inhibit or induce cytochrome
             (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose
             and throughout the study

          -  Drug allergies to fenofibric acid
Effectiveness of Two Different Doses of BI 1026706 on the Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of Laser (Somatosensory, Radiant-heat) Evoked Potentials (LEP) in UVB(Ultraviolet)-Irradiated Skin in Healthy Male Volunteers
Condition: Healthy
Intervention: Placebo to BI 1026706; Pregabalin; BI 1026706; Celecoxib
Intervention description: Placebo tablet; Pregabalin hard capsule; BI 1026706 oral solution; Celecoxib hard capsule
Intervention MeSH terms: Celecoxib; Pregabalin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Enrollment: 25.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      -  To investigate the influence of different doses of BI 1026706 on the primary endpoint
           (PtP-amplitude LEP in UV skin) compared to placebo.

        -  The comparison of both doses of BI 1026706 to celecoxib in the UVB treatment.

        -  Comparison of both doses of BI 1026706 to placebo and pregabalin in the capsaicin
           treatment

        -  Exploration of the pharmacokinetics of BI 1026706

        -  Exploration of safety and tolerability of BI 1026706
    

Eligibility criteria:

        Inclusion criteria:

          1. Healthy males according to the investigator's assessment, as based on the following
             criteria: a complete medical history including a physical examination, vital signs
             (Blood Pressure, Pulse Rate), 12-lead electrocardiogram, and clinical laboratory

          2. Age 18 to 55 years (incl.)

          3. BMI (Body Mass Index) 18.5 to 29.9 kg/m2 (incl.)

          4. Signed and dated written informed consent prior to admission to the study in
             accordance with GCP and local legislation

        Exclusion criteria:

          1. Any finding in the medical examination (including Blood Pressure, Pulse Rate or
             Electrocardiogram) deviating from normal and judged clinically relevant by the
             investigator

          2. Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic
             blood pressure greater than 90 mm Hg

          3. Any laboratory value outside the reference range that the investigator considers to be
             of clinical relevance

          4. Any evidence of a concomitant disease judged clinically relevant by the investigator

          5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders

          6. Surgery of the gastrointestinal tract that could interfere with kinetics of the study
             drug(s)

          7. Diseases of the central nervous system (such as epilepsy), other neurological
             disorders or psychiatric disorders
A Study of Abemaciclib in Healthy Participants
Condition: Healthy
Intervention: Abemaciclib; Placebo; Loperamide
Intervention description: Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Loperamide; Antidiarrheals
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purposes of this study are to determine:

        -  The effect of single increasing doses of the study drug, abemaciclib, on healthy
           participants.

        -  The relationship between the amount of abemaciclib and the electrical tracing of the
           heart rhythm when abemaciclib is given.

        -  How much abemaciclib is found in the bloodstream and how long the body takes to get rid
           of it.

      Information about any side effects that occur will be collected. The study will enroll two
      groups (cohorts) of participants. Each group will complete 4 study periods. This study is
      expected to last about 3 months. Screening may occur up to 28 days prior to enrollment. All
      participants will undergo a follow-up assessment approximately 21 days after administration
      of their final dose of study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy males or females, as determined by medical history and physical
             examination

               -  Male participants will be sterile

               -  Female participants must not be of childbearing potential

        Exclusion Criteria:

          -  Have known allergies to abemaciclib, related compounds, or any components of the
             formulation

          -  Have an abnormality in the 12-lead electrocardiogram (ECG) including a Fridericia's
             corrected QT interval (QTcF) greater than 450 milliseconds (ms) (males) or greater
             than 470 ms (females)

          -  Have a history or presence of cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine, hematological, or neurological disorders capable of
             significantly altering the absorption, metabolism, or elimination of drugs

          -  Have a gastrointestinal disorder causing clinically significant symptoms such as
             nausea, vomiting, and diarrhea, or malabsorption syndromes, or constipation

        Additional Exclusion Criterion for Participants Enrolled in Cohort 2:

          -  Have a known hypersensitivity to loperamide hydrochloride or to any of the excipients
The Effects of Denosumab on the Pharmacokinetics (PK) of Midazolam
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Denosumab; Midazolam
Intervention description: Eighteen (18) subjects will receive 1 fixed dose administration of denosumab.; All subjects will receive two oral dose administrations of midazolam.
Intervention MeSH terms: Denosumab; Midazolam
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Female
Minimum age: 45 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Amgen; Phase 1; Postmenopausal; Osteoporosis

Summary:

      This is a multi-center, open-label, drug-drug interaction study in postmenopausal women with
      osteoporosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between 45 to 75 years of age

          -  Postmenopausal women

          -  Osteoporosis

        Exclusion Criteria:

          -  Use of any known inhibitors of cytochrome P450 3A4/P-gp (CYP3A4) within 14 days or 5
             half lives, whichever is longer; or grapefruit juice or grapefruit containing products
             within 7 days prior to investigational product administration

          -  Use of any known CYP3A4 inducers within 30 days or 5 half-lives, whichever is longer,
             prior to investigational product administration

          -  Use of any herbal medicine with a known impact on CYP3A4 (eg, St. John's wort) within
             30 days prior to investigational product administration

          -  Current use of medications prescribed for osteoporosis treatment

          -  Use of midazolam within 14 days prior to investigational product administration

          -  Influenza or other vaccination within 28 days of screening

          -  Previous exposure to denosumab
Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management
Condition: COVID 19
MeSH terms: COVID-19
Intervention: Ivermectin (IVM)
Intervention description: Ivermectin 0.2 mg /kg (single dose at once =2 tablets of 6mg/weekly
Intervention MeSH terms: Ivermectin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Comparing the effectiveness of Ivermectin( IVM) +Hydroxychloroquin + azithromycin (AZT) group
      to Hydroxychloroquin (HCQ) + azithromycin (AZT)
    

Eligibility criteria:

        Inclusion Criteria:

        -1. Patients with age above 18 years and any gender with definite Dx of covid19 and
        pneumonia in the ward according to the clinical, laboratory, and imaging criteria.

        2. Understands and agrees to comply with planned study procedures.

        Exclusion Criteria:

          1. Patients with hypersensitivity or severe adverse effects to Ivermectin

          2. Renal impairment

          3. Hepatic impairment.

          4. Pregnancy or a desire to become pregnant (drug considered pregnancy category c)

          5. Breast feeding.

          6. Patient with covid 19 positive and mild no pneumonia

          7. Children under the age of five or those who weigh less than 15 kilograms
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab (TCZ) Administered to Participants With Giant Cell Arteritis (GCA).
Condition: Giant Cell Arteritis
MeSH terms: Polymyalgia Rheumatica; Giant Cell Arteritis; Arteritis
Intervention: Tocilizumab
Intervention description: TCZ will be administered by IV infusion at two dose levels Q4W. The maximum dose of TCZ that will be administered is 800 mg. The dose of TCZ infusion will be calculated on the basis of body weight measured prior to each infusion.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This study will evaluate the pharmacokinetics, pharmacodynamics, and safety of two dose
      levels of tocilizumab (TCZ) administered by intravenous (IV) infusion every 4 weeks (Q4W) to
      participants with giant cell arteritis (GCA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of GCA as classified according to protocol-specified criteria;

          -  Participants entering Period 1 must be receiving treatment with TCZ 8 mg/kg IV Q4W.

        Exclusion Criteria:

          -  Treatment with any other investigational agent besides TCZ within 12 weeks (or 5
             half-lives of the investigational drug, whichever is longer) prior to screening;

          -  Evidence of serious uncontrolled disease;

          -  Known active current or history of recurrent bacterial, viral, fungal, mycobacterial,
             or other infections;

          -  Active TB requiring treatment within the previous 3 years.
Drug-Drug Interaction Study of Colchicine and Theophylline
Condition: Pharmacokinetics
Intervention: Theophylline; Colchicine
Intervention description: single doses of 300 mg (80 mg/15 ml elixer) administered alone at 7:45 am on Day 1 and then along with colchicine at 7:45 am on Day 19; one 0.6 mg tablet twice daily at 7:45 am and 7:45 pm on Days 5 to 19
Intervention MeSH terms: Colchicine; Theophylline
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: healthy;; adult;; blood levels over time

Summary:

      Colchicine is a supressor of hepatic CYP1A2 and theophylline is a sensitive CYP1A2 probe
      substrate. When the two are co-administered the potential exists for a clinically significant
      drug interaction. This study aims to determine the effect of steady-state colchicine on the
      pharmacokinetics of theophylline administered as a single dose. A secondary goal is to
      evaluate the safety and tolerability of this regimen in healthy volunteers. All study
      subjects will be monitored for adverse events throughout the entire study period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults 18-45 years of age, non-smoking and non-pregnant (postmenopausal,
             surgically sterile or using effective contraceptive measures) with a body mass index
             (BMI) greater than or equal to 18 and less than or equal to 32, inclusive

        Exclusion Criteria:

          -  Recent participation (within 28 days) in other research studies

          -  Recent significant blood donation or donation of plasma

          -  Pregnant or lactating

          -  Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface
             antigen (HbsAg), or hepatitis C virus (HCV)

          -  Recent (2-year) history or evidence of alcoholism or drug abuse

          -  History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or
             biliary tract, renal, hematological, gastrointestinal, endocrine, immunologic,
             dermatologic, neurological, or psychiatric disease

          -  Subjects who have used any drugs or substances known to inhibit or induce cytochrome
             (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose
             and throughout the study
Pharmacokinetics Of CP-690,550 In Patients With Impaired Renal Function
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: CP-690,550; CP-690,550; CP-690,550; CP-690,550
Intervention description: 10 mg (2 x 5 mg tablets), single dose; 10 mg (2 x 5 mg tablets), single dose; 10 mg (2 x 5 mg tablets), single dose; 10 mg (2 x 5 mg tablets), single dose
Intervention MeSH terms: Tofacitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: CP-690; 550; pharmacokinetics; renal impairment

Summary:

      A study to evaluate the pharmacokinetics of CP-690,550 in subjects with mild, moderate or
      severe renal impairment, who do not require hemodialysis, compared to healthy controls.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with normal renal function: Subjects must be healthy with estimated
             creatinine clearance >80 mL/min

          -  Subjects with renal impairment: Subjects should be in good general health commensurate
             with the population with chronic kidney disease

        Exclusion Criteria:

          -  Kidney transplant patients

          -  Subjects with any condition possibly affecting drug absorption

          -  Subjects with malignancies with the exception of adequately treated basal cell
             carcinoma of the skin
Effects of Once and Twice Daily Dosing Regimen of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-040)
Condition: Diabetes Mellitus, Type 2; Adult
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Ertugliflozin 2 mg single dose; Ertugliflozin 2 mg split into twice daily; Ertugliflozin 4 mg single dose; Ertugliflozin 4 mg split into twice daily; Placebo
Intervention description: Ertugliflozin 2 mg dose (two 1 mg strength tablets), administered as a single dose; Ertugliflozin 1 mg dose (1 mg strength tablet) administered twice daily x 1 day; Ertugliflozin 4 mg dose (four 1 mg strength tablets), administered as a single dose; Ertugliflozin 2 mg dose (two 1 mg strength tablets) administered twice daily x 1 day; Placebo to ertugliflozin administered as a single dose
Intervention MeSH terms: Ertugliflozin
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a Phase 1 randomized, double-blind, sponsor open, 4 arm, 2 way cross-over study using
      2 cohorts. The objective of the study is to evaluate the pharmacodynamics (PD) effects and
      the pharmacokinetic (PK) of single day dosing of 2 mg and 4 mg doses of ertugliflozin (Ertu,
      PF-04971729/MK-8835) each administered once vs twice daily (morning [AM] and evening [PM]) in
      adults with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with type 2 diabetes mellitus, either treatment-naïve or on up to 2
             acceptable oral anti-diabetes drugs for at least 8-weeks prior to study.

        Exclusion Criteria:

          -  Participants with type 1 diabetes mellitus, participants with stroke, unstable angina,
             heart attack in last 6-months, uncontrolled blood pressure.
Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole
Condition: Healthy
Intervention: MAP0004; IV DHE; Ketoconazole
Intervention description: MAP0004 1.0mg via inhalation on Day 1 and Day 6 of Visit 2; IV DHE (Intravenous Dihydroergotamine Mesylate) administered at Visit 3; Ketoconazole 400 mg administered once a day on days 3-6 of Visit 2
Intervention MeSH terms: Ketoconazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Drug Interaction Study in Normal Healthy Volunteers

Summary:

      Compare the DHE pharmacokinetic profiles observed following administration of:

        1. MAP0004 (oral inhalation DHE)

        2. MAP0004 co-administered with oral Ketoconazole

        3. Intravenous (IV) DHE (D.H.E.45®, the approved reference therapy)

      Compare the tolerability of MAP0004, IV DHE, and MAP0004 with co-administration of
      Ketoconazole.
    

Eligibility criteria:

        Major Inclusion Criteria:

          -  Able to provide written Informed Consent

          -  Male or Female subjects 18 to 45 years old

          -  Female subjects who are practicing adequate contraception or who are sterile

          -  Stable cardiac status

          -  Normal rhythm or arrhythmia deemed clinically insignificant on ECG

        Exclusion Criteria:

          -  Contraindication to dihydroergotamine mesylate (DHE)

          -  Use of any excluded concomitant medications within the 10 days prior to Visit 1

          -  History of hemiplegic or basilar migraine

          -  Participation in another investigational trial during the 12 weeks prior to Visit 1 or
             during this trial
A Safety, Tolerability, and Pharmacokinetics (PK) Study of AGN-223575 in Healthy Subjects
Condition: Healthy Volunteers
Intervention: AGN-223575 Formulation A; AGN-223575 Formulation B; AGN-223575 Formulation C; AGN-223575 Vehicle
Intervention description: One drop of AGN-223575 Formulation A administered in the study eye(s) per protocol.; One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15.; One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.; One drop of AGN-223575 vehicle administered in the study eye(s) per protocol.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of AGN-223575 in
      healthy subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Weight at least 110 lbs

        Exclusion Criteria:

          -  Use of contact lenses within 14 days, or planned use during the study

          -  Use of any ocular eye medications within 30 days, or anticipated use during the study

          -  Anticipated use of any artificial tears product during the study