bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Participants With Type 2 Diabetes (MK-8655-002)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: MK-8655; Placebo
Intervention description: Participants will receive MK-8655 as a single dose on Day 1. Participants will receive MK-8655, once a day (q.d.), for 14 consecutive days (Day 3 through Day 16). MK-8655 doses may be adjusted downward based on the results of ongoing studies.; Participants will receive Placebo as a single dose on Day 1. Participants will receive Placebo, q.d., for 14 consecutive days (Day 3 through Day 16).
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes

Summary:

      This study will assess the initial safety, tolerability, pharmacokinetics, and
      pharmacodynamics of MK-8655, after single and multiple daily oral administrations to
      participants with Type 2 Diabetes (T2DM). The study will assess the reduction in fasting
      plasma glucose concentrations from baseline after multiple daily administrations of MK-8655.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female of non-child bearing potential

          -  Body Mass Index ≤40 kg/m^2

          -  Diagnosis of Type 2 Diabetes (T2DM) and is either drug naive or is being treated with
             metformin only

          -  In good health except for T2DM

          -  Willing to follow a standard diet

          -  Nonsmoker and/or no use of nicotine or nicotine-containing products for 6 months

        Exclusion Criteria:

          -  Mentally or legally incapacitated

          -  History of stroke, chronic seizures, or major neurological disorder

          -  History of clinically significant endocrine (except T2DM), gastrointestinal,
             cardiovascular, hematological, hepatic, immunological, renal, respiratory, or
             genitourinary abnormalities or diseases

          -  History of neoplastic or myeloproliferative diseases

          -  Has clinical unstable or rapidly progressing diabetic retinopathy, neuropathy, and/or
             frequent nausea, bloating or vomiting, severe gastroesophageal reflux or early satiety

          -  Has a history of Type 1 Diabetes and/or history of ketoacidosis

          -  Use of any lipid-lowering therapies in the past 3 months

          -  Non-permitted medication for a co-morbid condition

          -  Excessive alcohol or caffeine use

          -  Participation in another investigational study within 4 weeks prior to this study

          -  A history of significant multiple and/or severe allergies or anaphylactic reactions

          -  Regular user of any illicit drugs or history of alcohol abuse within 6 months
Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults
Condition: Evaluate PK Profile
Intervention: nirsevimab; Placebo
Intervention description: Drug: injection, a single fixed IM dose on day 1 only.; Placebo: injection, 0.9% (w/v) saline, a single fixed IM dose on day 1 only.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PK; safety; tolerability; Nirsevimab; healthy Chinese Adults; Respiratory Syncytial Viral (RSV)

Summary:

      The purpose of this study is to evaluate the Pharmacokinetics, Safety, Tolerability of
      Nirsevimab in Healthy Chinese Adults.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 to 45 years

          2. Weight ≥ 45 kg and ≤ 110 kg and Body Mass Index of 19 to 26 kg/m2

          3. Healthy Chinese subjects (both male and female)

          4. Normotensive

          5. Normal electrocardiogram (ECG) within 28 days prior to Day 1

        Exclusion Criteria:

          1. Acute illness at study entry (pre-dose on Day 1)

          2. Fever ≥99.5°F (37.5°C) on day of dosing

          3. Any drug therapy within 14 days prior to Day 1 (except contraceptives).

          4. Receipt of immunoglobulin or blood products within 6 months prior to study entry.

          5. Receipt of any investigational drug therapy within 120 days prior to investigational
             product dosing or planned to receive any investigational drug therapy within 150 days
             after investigational product dosing.

          6. Previous receipt of any marketed or investigational mAb.

          7. Previous vaccination against RSV.

          8. History of immunodeficiency or receipt of immunosuppressive medications during the
             prior year.

          9. History of asthma.

         10. History of autoimmune disorder.

         11. Evidence of any systemic disease on physical examination.

         12. Evidence of infection with hepatitis A, B, or C virus, syphilis, or human
             immunodeficiency virus.

         13. Any clinically significant abnormal laboratory assessments at screening.

         14. Pregnant or nursing mother.

         15. Alcohol or drug abuse
Dose-Titration and Open-label Extension Study of SRP-4045 in Advanced Stage Duchenne Muscular Dystrophy (DMD) Patients
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: SRP-4045; Placebo
Intervention description: SRP-4045 solution for IV infusion.; SRP-4045 placebo-matching solution for IV infusion.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: Male
Minimum age: 7 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Duchenne muscular dystrophy; Exon Skipping

Summary:

      This is a first-in-human dose-titration and open-label extension study to assess safety,
      tolerability, and pharmacokinetics of SRP-4045 in advanced-stage Duchenne muscular dystrophy
      (DMD) patients with deletions amenable to exon 45 skipping.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Genotypically confirmed DMD (amenable to exon 45 skipping).

          -  Stable cardiac and pulmonary function.

          -  Limited or no ambulation.

          -  On a stable dose of oral corticosteroids for at least 24 weeks OR has not received
             corticosteroids for at least 24 weeks.

        Exclusion Criteria:

          -  Current or previous treatment with the experimental agents SMT C1100 (BMN-195) or
             PRO045.

          -  Other experimental treatment in the past 12 weeks.

          -  If on cardiac medication, must be on a stable dose for the past 12 weeks.

          -  Major surgery within the past 3 months.

        Other inclusion/exclusion criteria apply.
Dose Escalation Trial of Intra-Tumoral Injection of NIS Measles Virus in Combination With Atezolizumab
Condition: Recurrent Non-Small Cell Lung Cancer
MeSH terms: Measles; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: MV-NIS; Atezolizumab
Intervention description: This is an open label single ascending dose phase I study designed to determine the safety profile and MTD after IT administration of a single dose of MV-NIS in combination with Atezolizumab in patients with metastatic NSCLC; Atezolizumab will be administered every 3 weeks
Intervention MeSH terms: Atezolizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung Cancer Measles Nivolumab Opdivo

Summary:

      This a Phase 1 study designed to determine the maximum tolerated dose (MTD) and toxicity of
      attenuated Measles virus (MV-NIS) combined with Atezolizumab in patients with recurrent and
      metastatic NSCLC.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of metastatic lung cancer, with histologic confirmation of the primary NSCLC
             histology and with at least one lesion amenable for intra-tumoral injection of MV-NIS.

          -  Patient meets the FDA-approved indication for Atezolizumab treatment in NSCLC.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.

          -  Ability to provide informed consent.

          -  Adequate hematological, liver and kidney function.

          -  Must be willing to implement contraception throughout study and for the 8 weeks
             following last study drug administration.

        Key Exclusion Criteria:

          -  Any of the following prior therapy: Chemotherapy ≤ 3 weeks prior to registration.
             Biologic therapy ≤ 4 weeks prior to registration. Radiation therapy ≤ 3 weeks prior to
             registration

          -  Other concurrent investigational therapy (utilized for a non-FDA-approved indication
             and in the context of a research investigation).

          -  Pregnant women.

          -  Nursing women.

          -  Men or women of childbearing potential who are unwilling to employ adequate
             contraception during treatment and 8 weeks following the completion of study drug
             treatment.

          -  Allergy to measles vaccine or history of severe reaction to prior measles vaccination.

          -  History of organ transplantation.
Interactions Between Cannabinoids and Cytochrome P450-Metabolized Drugs
Condition: Drug-Interactions
Intervention: Inje cocktail; THC Cannabis extract; THC/CBD Cannabis Extract
Intervention description: Acute drug exposure; Acute drug exposure; Acute drug exposure
Intervention MeSH terms: Dronabinol
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking description: Placebo controlled, double blind
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate drug-drug interactions between cannabis extracts containing
      Tetrahydrocannabinol (THC) and THC+ Cannabinoids (CBD) and probe drugs for select CYP450
      pathways including: caffeine (CYP1A2), omeprazole (CYP2C19), losartan (CYP2C9),
      dextromethorphan (CYP2D6), and midazolam (CYP3A).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult between 18-50 years old

          -  BMI between 18 to 34 kg/m2

          -  Willing to use birth control

          -  Willing to abstain from all medications and citrus fruits for the duration of the
             study

        Exclusion Criteria:

          -  Medical or psychiatric illness judged by the investigator to put the participant at
             greater risk of experiencing an adverse event due to drug exposure or completion of
             other study procedures.

          -  Use of medications which, in the opinion of the investigator or medical staff, will
             interfere with the study outcomes or the safety of the participant.

          -  Clinically significant impairment of kidney, liver, or thyroid function (serum
             creatinine >1.2 mg/ml (kidney), liver function tests >3x the upper limit of normal
             (alanine amino transferase >99 U/L; aspartate amino transferase > 99 U/L), and thyroid
             stimulating hormone > 4.2 uIU/ml), or evidence of current anemia based on blood
             chemistry testing.

          -  History of adverse events associated with the ingestion of cannabis or any medications
             in the Inje cocktail judged by the investigator to present an undue risk of harm to
             the participant.
Kappa-PET Imaging and Naltrexone in Alcohol Drinking Behaviors
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking; Drinking Behavior
Intervention: Naltrexone
Intervention description: Naltrexone 100 mg titrated over one week
Intervention MeSH terms: Naltrexone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Alcohol; Drinking; Drinkers; Alcohol Drinking; Naltrexone; Alcohol Dependence; Alcohol Abuse; Alcohol-Related Disorders; Ethanol; Alcoholism

Summary:

      The primary purpose of the study is to increase our knowledge of receptor function in the
      brains of people who are heavy drinkers and taking naltrexone (NTX), a medication that has
      been approved for the treatment of alcohol dependence. Receptors are special molecules in the
      brain to which other molecules (neurotransmitters) attach during the normal every-day
      workings of the brain. Drugs can bind to those receptor molecules as well. Recent evidence
      suggests that kappa opioid receptors (KOR's) may play an important role in alcohol drinking
      behavior. This study will try to determine if naltrexone's ability to attach to these
      receptors is related to its effectiveness. We will use PET (positron emission tomography) for
      this study. PET is a type of imaging device found in nuclear medicine. It is used for
      tracking the presence of injected radioactive materials in the body.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 21-50

          -  Able to read English at 6th grade level or higher and to complete study evaluations

          -  Regular alcohol drinker

        Exclusion Criteria:

          -  Individuals who are seeking alcohol treatment

          -  Medical conditions that would contraindicate the use of study medication

          -  Regular use of other substances
Effect of a Proton Pump Inhibitor on the PK of Tepotinib
Condition: Healthy
Intervention: Tepotinib; Omeprazole
Intervention description: Participants received single oral dose of 500 mg Tepotinib in Treatment A, B and C.; Participants received omeprazole alone on Day 1 to 4 and co-administration of omeprazole with Tepotinib on Day 5 in Treatment B and C.
Intervention MeSH terms: Tepotinib; Omeprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Proton Pump Inhibitor; Omeprazole; Tepotinib; Non-small cell lung cancer (NSCLC); Pharmacokinetics

Summary:

      This study was investigated in healthy participants (i) the effect of omeprazole (proton pump
      inhibitor) co-administration on the single dose pharmacokinetics (PK) of tepotinib under fed
      conditions, and (ii) the effect of food on the single dose PK of tepotinib after
      co-administration of omeprazole and tepotinib. Furthermore, the study assessed the safety and
      tolerability of tepotinib alone and upon co-administration of omeprazole.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy participants of non-child bearing potential

          -  Body mass index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m^2)

          -  Body weight between 50 to 100 kilogram (kg)

          -  Other protocol defined inclusion criteria could apply

        Exclusion Criteria:

          -  Participation in a clinical study within 60 days prior to first drug administration

          -  Whole blood donation or loss of greater than (>) 450 milliliter (mL) within 60 days
             prior to first drug administration

          -  Any surgical or medical condition, or any other significant disease that could
             interfere with the study objectives, conduct, or evaluation

          -  Other protocol defined exclusion criteria could apply
Pharmacokinetics and Hepatic Safety of EGCG
Condition: Uterine Fibroids
MeSH terms: Leiomyoma
Intervention: Epigallocatechin gallate (EGCG); Clomiphene Citrate; Letrozole
Intervention description: 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months; 100 mg for 5 days; 5 mg for 5 days
Intervention MeSH terms: Letrozole; Epigallocatechin gallate; Clomiphene; Enclomiphene; Zuclomiphene
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The 36 women will be randomized to one of the following groups:
EGCG daily alone.
EGCG daily with clomiphene citrate 100mg for 5 days.
EGCG daily with letrozole 5mg for 5 days.
Masking: None (Open Label)
Enrollment: 39.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A trial to assess the pharmacokinetics and hepatic safety of EGCG in women with and without
      uterine fibroids.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy women ≥18 to ≤40 years of age with or without uterine fibroids

          2. Must use a double-barrier method for contraception

        Exclusion Criteria:

          1. Subjects using green tea/EGCG within 2 weeks prior to study enrollment

          2. Known liver disease (defined as AST or ALT>2 times normal, or total bilirubin >2.5
             mg/dL).

          3. History of alcohol abuse (defined as >14 drinks/week) or binge drinking of ≥ 6 drinks
             at one time).

          4. Subject using hormonal contraceptives

          5. Subjects who are pregnant or breastfeeding

          6. Known hypersensitivity to the study drugs

          7. Any chronic disease
Bioequivalence Study of Brexpiprazole Orally Disintegrating Tablets (ODT) 2mg
Condition: Healthy Adult Male
Intervention: Brexpiprazole ODT 2mg with water; Brexpiprazole ODT 2mg without water; Brexpiprazole conventional tablet 2mg
Intervention description: Brexpiprazole ODT 2mg is administered with water.; Brexpiprazole ODT 2mg is administered without water.; Brexpiprazole conventional tablet 2mg is administered with water.
Intervention MeSH terms: Brexpiprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: Male
Minimum age: 20 Years
Maximum age: 39 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To investigate the bioequivalence of brexpiprazole ODT 2 mg and brexpiprazole conventional
      tablet 2 mg
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Japanese males

          -  BMI ［body weight in kg /(height in m)2］ of at least 18.5 kg/m2 and less than 25.0
             kg/m2 (as a result of at the screening examination)

          -  Capable of providing written informed consent prior to initiation of any trial-related
             procedures, and able, in the opinion of the investigator, to comply with all
             requirements of the trial

        Exclusion Criteria:

          -  Clinically significant abnormality at the time of screening (eg, significant deviation
             from reference ranges) or in medical history that, in the opinion of investigator,
             subinvestigator, or sponsor may place the subject at risk or interfere with outcome
             variables such as drug absorption, distribution, metabolism, and excretion

          -  History of serious mental disorder

          -  History of drug or alcohol abuse within 2 years prior to screening

          -  History of any significant drug allergy

          -  Use of another investigational drug within 120 days prior to the first administration
             of IMP

          -  Consumption of grapefruit, grapefruit products, Seville oranges, Seville orange
             products, Star fruit, or Star fruit products within 72 hours prior to the first
             administration of IMP or consumption of alcohol within 72 hours prior to
             administration of IMP

          -  Use of prescription, over-the-counter (OTC), or herbal medication, or vitamin
             supplements, or consumption of food or beverages containing St. John's Wort within 14
             days prior to the first administration of IMP, or use of antibiotics within 30 days
             prior to the first administration of IMP

          -  History of major surgery of the digestive tract (excluding appendectomy)

          -  Any subject who, in the judgement of the investigator or subinvestigator, should not
             participate in the trial
A Study of Cabiralzumab Given by Itself or With Nivolumab in Advanced Cancer or Cancer That Has Spread
Condition: Advanced Malignancies
MeSH terms: Neoplasms
Intervention: Cabiralizumab; Nivolumab
Intervention description: Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Nivolumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel assignment will only in combination therapy arm.
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether an investigational immuno-therapy,
      cabiralizumab in combination with nivolumab, is safe and tolerable in the treatment of
      advanced malignancies.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Performance status 0-1

          -  Adequate organ function

          -  Cohort M1, 2 and C1: Measurable disease

          -  Cohort M1, M2 and C1: Subjects must have histologic or cytologic confirmation of an
             advanced (metastatic and/or unresectable) malignant solid tumor

          -  Cohort C2: Documented refractory or relapsed multiple myeloma

          -  Subjects must be refractory to or have relapsed after standard therapies, or have no
             known effective treatment

        Exclusion Criteria:

          -  Cohort M1, M2, and C1: Untreated or active central nervous system (CNS) or
             leptomeningeal metastases

          -  Cohort M1, M2, and C1: Subjects with hepatocellular carcinoma (HCC)

          -  Cohort C2: Subjects with solitary bone or extramedullary plasmacytoma as the only
             evidence of plasma cell dyscrasia

        Other protocol defined inclusion/exclusion criteria could apply