bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults
Condition: Healthy Adults
Intervention: Drug:OP0201; Drug: Placebo
Intervention description: Drug: OP0201; Drug: Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults
    

Eligibility criteria:

        Inclusion Criteria includes but is not limited to:

          1. Body Mass Index (BMI) 18 to 30 and a minimum body weight of 50 kg at screening.

          2. No history or presence of significant medical condition or a clinically significant
             abnormal finding, as determined by the investigator.

          3. Negative urine pregnancy test at screening and baseline for females of childbearing
             potential

          4. Agree to refrain from water immersion of the ears from the time of signed informed
             consent to the end of trial

          5. Physiologic tympanogram type A (normal) or type C at screening visit

        Exclusion Criteria includes but is not limited to:

          1. Known substance abuse (e.g., alcohol, licit or illicit drugs) within 96 weeks prior to
             screening visit

          2. Positive urine drug screen at screening visit

          3. Upper respiratory tract infection currently or within 6 weeks prior to screening visit

          4. Allergy or sinus conditions (e.g., sinusitis, non-specific nasal inflammation)
             currently or within 6 weeks prior to screening visit

          5. Claustrophobia that is sufficient to prevent them tolerating assessments while in a
             hypobaric/hyperbaric atmospheric pressure chamber

          6. Smoker (e.g ., cigarettes, vapor) within the last 48 weeks prior to screening visit

          7. Clinically significant findings on ear nose and throat exam

          8. Gastroesophageal reflux disease currently or within 6 weeks prior to screening visit

          9. Current diagnosis of sleep apnea

         10. Evidence of craniofacial anomalies (eg, cleft palate, Down's Syndrome) that may
             interfere with ET function

         11. Disorders with decreased mucociliary clearance or higher viscosity of the mucous (eg,
             cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)
Multiple Ascending Doses of Rozibafusp Alfa (AMG 570) in Adults With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Rozibafusp Alfa; Placebo
Intervention description: Administered by subcutaneous injection once every 2 weeks.; Administered by subcutaneous injection once every 2 weeks.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      A study to evaluate safety and tolerability and characterize the pharmacokinetic (PK) profile
      of rozibafusp alfa following multiple dose administration in adults with rheumatoid arthritis
      (RA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body Mass Index: 18-35 kg/m^2

          -  Diagnosed with RA (disease duration of at least 6 months)

          -  Stable dose of methotrexate (5-25 mg weekly for ≥ 4 weeks)

          -  Immunizations up to date

          -  Willing to use highly effective contraception during treatment and through
             end-of-study

        Exclusion Criteria:

          -  Uncontrolled, clinically significant systemic disease other than RA (i.e., diabetes
             mellitus, liver disease, asthma, cardiovascular disease, hypertension)

          -  Malignancy within 5 years

          -  Presence of serious infection, recurrent/chronic infections

          -  Class IV RA according to American College of Rheumatology/ (ACR) revised response
             criteria

          -  Diagnosed with Felty's syndrome

          -  Known or suspected sensitivity to mammalian cell-derived products

          -  History of alcohol and/or substance abuse within the last 12 months

          -  Receipt of rituximab at any time in the past

          -  Evidence of renal disease
Study of ALXN1840 on the Metabolism of a CYP2B6 Substrate in Healthy Participants
Condition: Wilson Disease
MeSH terms: Hepatolenticular Degeneration
Intervention: ALXN1840; Bupropion Hydrochloride
Intervention description: ALXN1840 will be administered orally as a single dose as 4 x 15 mg enteric-coated tablets with 240 milliliters of water (fasting), for a total dose of 60 mg.; Bupropion hydrochloride will be administered orally as a single dose as one 150 milligrams (mg) tablet with 240 milliliters of water (fasting).
Intervention MeSH terms: Tetrathiomolybdate; Choline; Bupropion
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cytochrome P450; Healthy; ALXN1840

Summary:

      This is a Phase 1, randomized, 2-period, 2-sequence, cross-over study designed to determine
      the effect of ALXN1840 on the metabolism of bupropion, a sensitive cytochrome P450 2B6
      (CYP2B6) substrate, in healthy male and female participants. The safety and tolerability of
      ALXN1840 will be determined along with ALXN1840 pharmacokinetics (PK) in plasma as measured
      via total molybdenum with the coadministration of bupropion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adequate venous access in the left or right arm to allow the collection of blood
             samples.

          -  Body weight ≥ 45 to ≤ 100 kilograms (kg) and body mass index within the range of 18 to
             < 30 kg/meter squared.

          -  Willing and able to follow protocol-specified contraception requirements.

          -  Capable of giving signed informed consent.

        Exclusion Criteria:

          -  History or presence of/significant medical history.

          -  Clinically significant multiple or severe allergies.

          -  Lymphoma, leukemia, or any malignancy within 5 years.

          -  Breast cancer within the past 10 years.

          -  Serum creatinine > upper limit of normal (ULN) of the reference range.

          -  Alanine aminotransferase, aspartate aminotransferase, or total bilirubin > ULN.

          -  Current or chronic history of liver disease or known hepatic or biliary abnormalities
             (with the exception of Gilbert's syndrome or asymptomatic gallstones).

          -  QTc > 450 milliseconds (msec) for male participants or > 470 msec for female
             participants.
A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-788 Followed by Evaluation of the Effects of a Low-Fat Meal on TAK-788 PK and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Participants
Condition: Healthy Volunteers
Intervention: TAK-788; Placebo; TAK-788
Intervention description: TAK-788 capsules.; TAK-788 placebo-matching capsules.; TAK-788 DiC.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to assess the safety, tolerability of TAK-788 and to identify a
      tolerable single oral dose of TAK-788 administered as a drug-in-capsule (DiC) formulation, to
      characterize the effects of a low-fat meal on the PK of the TAK-788 administered as DiC
      formulation and to evaluate the bioavailability of a test (Process B) DiC of TAK-788 relative
      to a reference (Process A) DiC of TAK-788 in healthy participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Body weight of greater than or equal to (>=) 45 kilogram (kg) (women) or >=55 kg (men)
             and a body mass index of 18.0 to 30.0 kilogram per square meter (kg/m^2) at screening.

          2. Nonsmoker (never smoked or greater than [>] 20 years from last occurrence of smoking).

          3. Normal organ function including hepatic, renal, and bone marrow function.

        Exclusion Criteria:

          1. Manifestations of malabsorption due to prior gastro-intestinal (GI) surgery, GI
             disease, or for an unknown other reason that may alter the PK of TAK-788.

          2. Pulmonary infection ongoing or within 30 days of informed consent.

          3. Inability to undergo venipuncture and/or tolerate venous access.

          4. Inability to tolerate multiple blood sampling.

          5. Ongoing or active infection, including but not limited to, the requirement for
             intravenous (IV) antibiotics.
Treatment of Participants With Advanced and/or Refractory Solid Tumors (MK-5108-001)
Condition: Cancer, Neoplasms, Tumors
Intervention: MK-5108; docetaxel
Intervention description: MK-5108 will be administered orally, every 12 hours (Q12H) during the first 2 days of each cycle. Cycle length will be 14-21 days in Panel 1 and 21 days in Panel 2.; Docetaxel will be administered intravenously (I.V.) at a dose of 60 mg/m^2 Q12H during the first 2 days of each 21-day cycle.
Intervention MeSH terms: Docetaxel
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will investigate the safety, side effects and how well the body tolerates MK-5108
      as well as determine different doses of MK-5108 in participants with advanced and/or
      refractory solid tumors. The corresponding primary hypotheses of this study are that 1)
      administration of oral MK-5108 (twice daily for 2 out of 14-21 days) to participants with
      advanced and/or refractory solid tumors will be safe and tolerable, and that 2) the spectrum
      of side effects observed in these participants after administration of oral MK-5108 alone and
      in combination with docetaxel will be dose-dependent and allow for definition of a maximum
      tolerated dose (MTD).
    

Eligibility criteria:

        Inclusion Criteria:

        - Participant has a histologically-confirmed metastatic or locally advanced solid tumor
        that has failed to respond to standard therapy or progressed with standard therapy

        Exclusion Criteria:

          -  Participant has had chemotherapy, radiotherapy or biological therapy within 4 weeks
             prior to study start or has not recovered from adverse events caused by therapy more
             than 4 weeks earlier

          -  Participant is currently participating or has participated in a study with an
             investigational compound or device within 4 weeks prior to signing informed consent

          -  Participant has received more than 2 courses of chemotherapy for metastatic disease

          -  Participant has had prolonged neutropenia or neutropenia with fever from previous
             chemotherapy treatment

          -  Participant has a primary central nervous system tumor

          -  Participant is a regular or recreational user of any illicit drugs or has a recent
             history within the last year of drug or alcohol abuse

          -  Participant is pregnant, breastfeeding or planning to have children during the study

          -  Participant is Human Immunodeficiency Virus (HIV) positive

          -  Participant has a history of Hepatitis B or C
A Single Dose Study of MK-8266 (MK-8266-001)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: MK-8266 0.1 mg; MK-8266 1.0 mg; Placebo
Intervention description: Single oral doses of 0.1 to 1.2 mg of MK-8266 in 0.1 capsule form. Participants will fast for 8 hours prior to dosing. There will be at least a 7- day washout period between doses for any given participant. Some participants will receive study drug with food.; MK-8266 1.0 mg oral capsule. Participants will fast for 8 hours prior to dosing. There will be at least a 7- day washout period between doses for any given participant.; Placebo to match MK-8266 0.1 or 1.0 mg. Participants will fast for 8 hours prior to dosing. There will be at least a 7- day washout period between doses for any given participant.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 25.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A three panel study, to determine if MK-8266 given as a single dose is sufficiently safe and
      well tolerated. Panel A and B will consist of healthy young males and Panel C will consist of
      subjects with mild to moderate hypertension. The primary hypotheses for the study are that
      MK-8266 given as single doses is sufficiently safe and well tolerated to permit continued
      clinical investigation in healthy young male volunteers and male participants with
      mild-to-moderate hypertension and that in males with mild to moderate hypertension, at a
      single oral dose of MK-8266 that is sufficiently safe and well-tolerated, postdose mean
      time-weighted average across 24 hours of aortic augmentation index (TWA0-12hrs AIx) is
      reduced compared to placebo. A mean decrease of ≥ 5 percentage points is considered
      clinically meaningful.
    

Eligibility criteria:

        Inclusion Criteria:

          -  For Panel A and B Participant is a healthy male between 18 to 45 years of age. For
             Panel C Participant is a male with essential hypertension between 18 to 55 years of
             age

          -  A non-smoker

        Exclusion Criteria:

          -  Has a history of stroke, chronic seizure or major neurological disorder

          -  Has a disability that can interfere with rising from a sitting position to the
             standing position

          -  Has a personal of family history of bleeding or clotting disorders

          -  Has a history of cancer

          -  Is unable to refrain from or anticipates the use of any prescription or
             nonprescription drug during the study

          -  Consumes excessive amounts of caffeine or alcohol

          -  Has had major surgery, donated blood or participated in another investigational study
             in the past 4 weeks
A Comparative Bioavailability and Pharmacokinetic Study of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets in Healthy Adults.
Condition: Healthy
Intervention: Treatment A; Treatment B; Treatment C
Intervention description: TNX-102 2.4 mg - 1 gelcap once under fasting conditions.; Cyclobenzaprine 5 mg, 1 tablet once under fasting conditions; TNX-102 2.4 mg, 1 gelcap once given under fed conditions.
Intervention MeSH terms: Amitriptyline; Cyclobenzaprine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The trial is designed to assess the safety and tolerability of TNX-102 2.4 mg and to compare
      the bio-availability of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed
      conditions.
    

Eligibility criteria:

        Inclusion Criteria: Healthy adults

          -  Male or female

          -  Non-smoker

          -  18-55 years old

          -  BMI > 18.5 and < 30.0

          -  With medically acceptable form of contraception (female only).

        Exclusion Criteria:

          -  Any clinically significant abnormality or vital sign abnormalities

          -  Any abnormal laboratory test

          -  History of alcohol or drug abuse or dependence within 1 year and/or positive drug,
             cotinine, or alcohol tests

          -  Use of any drug (within 30 days), supplement, or food (within 14 days) known to induce
             or inhibit hepatic drug metabolism prior to study medication

          -  Positive pregnancy test, breastfeeding or lactating

          -  Use of medication other than hormonal contraceptives or topical products, including
             OTC, natural health products, MAO inhibitors

          -  Participation in an investigational study within 30 days prior to dosing

          -  Donation of plasma (within 7 days), or donation or loss of blood of 50-499 mL (within
             30 days), or of > 499 mL (within 56 days) prior to dosing.
A Renal Impairment Study for PF-06651600
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: PF-06651600
Intervention description: PF-06651600 50 mg oral tablets will be administered on Days 1 to 10
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 1 non-randomized, open-label, parallel cohort study of PF-06651600 in
      subjects with severe renal impairment and subjects without renal impairment (Part 1) and in
      subjects with mild and moderate renal impairment (Part 2).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) of >/= 17.5 to </= 40.0 kg/m2; and a total body weight > 50 kg
             (110 lb)

        Additional inclusion criteria for subjects with renal impairment:

          -  Meet the following eGFR criteria during the screening period based upon MDRD equation:

          -  Severe renal impairment: eGFR <30 mL/min but not requiring hemodialysis

          -  Moderate renal impairment (Part 2 only): eGFR >/=30 mL/min and <60 mL/min

          -  Mild renal impairment (Part 2 only): eGFR between 60 and 89 mL/min

          -  Any form of renal impairment except acute nephritic syndrome (subjects with history of
             previous nephritic syndrome but in remission can be included)

          -  Stable drug regimen

        Exclusion Criteria:

          -  Females of child-bearing potential must use an accepted, highly effective
             contraceptive method

          -  Renal transplant recipients

          -  Urinary incontinence without catheterization

          -  Subjects with clinically significant infections within the past 6 months prior to
             first dose of study drug, evidence of active or chronic infection requiring oral
             treatment within 4 weeks prior, history of disseminated herpes simplex or recurrent or
             disseminated herpes zoster

          -  Subjects with malignancy or with a history of malignancy, with the exception of
             adequately treated or excised non-metastatic basal cell or squamous cell cancer of
             skin or cervical carcinoma in situ

          -  HIV, Hepatitis B, or Hepatitis C infection

        Additional exclusion criteria for subjects with renal impairment:

          -  Subjects requiring hemodialysis and peritoneal dialysis

          -  Screening BP >/=180 mmHg (systolic) or >/=110 mmHg (diastolic)

          -  Screening 12-lead ECG demonstrating QTcF >470 msec
A Study of LY900014 Versus Insulin Lispro (Humalog) on High Blood Sugar in Participants With Type 1 Diabetes Who Use Insulin Pumps
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY900014; Insulin Lispro
Intervention description: Administered by CSII; Administered by CSII
Intervention MeSH terms: Insulin Lispro
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to compare LY900014 to insulin lispro (Humalog) in
      participants with type 1 diabetes who are using an insulin pump and have high blood sugar
      after eating. For each participant, the study will last about two to nine weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants with type 1 diabetes

          -  Body mass index (BMI) between 18.5 and 30.0 kilograms per square meter, inclusive

          -  Hemoglobin A1c (HbA1c) less than or equal to 8.5 percent (%)

          -  Using CSII and stable insulin regimen for at least 3 months prior to inclusion into
             the trial

        Exclusion Criteria:

          -  Known or suspected hypersensitivity to investigational medical product(s) or related
             products

          -  Receipt of any medicinal product in clinical development within 30 days or at least 5
             half-lives of the related substances and their metabolites (whichever is longer)
             before randomization in this trial

          -  Known slowing of gastric emptying and or gastrointestinal surgery that, in the opinion
             of the investigator, might change gastrointestinal motility and food absorption

          -  Proliferative retinopathy or maculopathy as judged by the Investigator based on a
             recent (less than 1.5 years) ophthalmologic examination

          -  Widespread subcutaneous lipodystrophy in the abdomen

          -  Current use of any glucose-lowering agents other than insulin within 3 months prior to
             screening

          -  Chronic or recent use of corticosteroids