bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic Study of Oral ALXN1840 in Japanese and Non-Japanese Adult Healthy Participants
Condition: Wilson Disease
MeSH terms: Hepatolenticular Degeneration
Intervention: ALXN1840
Intervention description: Tablet for oral use.
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: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of the study is to confirm how long ALXN1840 stays in the body of Japanese
      and non-Japanese healthy participants (that is, pharmacokinetic [PK] profile).
    

Eligibility criteria:

        Key Inclusion Criteria: - Body weight ≤80 kilograms (kg) and body mass index (BMI) within
        the range 18-25 kg/m^2, inclusive, at screening. - Negative serum pregnancy test. - Female
        participants of childbearing potential and male participants with a female spouse or
        partner of childbearing potential must be willing to follow protocol-specified
        contraception guidance starting at least one menstrual cycle before first study drug
        administration and continuing for up to 3 months after the end of systemic exposure of the
        study drug (that is, 3 months after end of study visit).

        Key Exclusion Criteria: - Current or recurrent/chronic disease (for example,
        cardiovascular, hematological, neurological, endocrine, immunological, rheumatological,
        renal, hepatic, or gastrointestinal (GI) or other conditions) that or could affect clinical
        assessments or clinical laboratory evaluations. - Current or relevant history of physical
        or psychiatric illness that are not stable or may require a change in treatment, use of
        prohibited therapies during the study or make the participant unlikely to fully comply with
        the requirements of the study or complete the study, or any condition that presents undue
        risk from the study drug or study procedures. - Any other significant disease or disorder
        which, in the opinion of the Investigator, may put the participant at risk. - History of
        significant allergic reaction (for example, anaphylaxis or angioedema) to any product (for
        example, food, pharmaceutical). - Use of prescription medications (excluding oral
        contraceptives) within 14 days prior to dosing on Day 1, except with prior approval of
        Alexion. - Use of non-prescription/ over-the-counter medications including vitamins and
        dietary or herbal supplements, within 7 days prior to dosing on Day 1. - Donated or lost
        400 milliliters (mL) blood or more within the last 16 weeks preceding the first day of
        dosing.
Reducing Dyskinesia in Parkinson's Disease With Omega-3 Fatty Acids
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Dyskinesias
Intervention: Docosahexaenoic Acid (DHA); Placebo
Intervention description: Docosahexaenoic Acid (DHA) 2 grams per day taken for 1.5 years; Sugar Pill, taken for 1.5 years
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 33.0
Sex: All
Minimum age: 21 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Parkinsons disease; supplement; DHA; dyskinesia; abnormal movements

Summary:

      The purpose of this research study is to measure the safety (side effects) of an Omega 3
      Fatty acid called docosahexanoic acid (DHA) and measure the dyskinesia (involuntary
      movements) in Parkinson 's disease (PD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with Parkinsons disease

          -  No levodopa (Sinemet) treatment or prior exposure to levodopa

        Exclusion Criteria:

          -  Prior exposure to levodopa

          -  Unable to stand for 1 minute without aid

          -  Sensory deficits on feet

          -  Significant cognitive impairment

          -  Current use of dopamine receptor blocking medications (depakote, lithium, amiodarone,
             tetrabenazine, metoclopramide, dronabinol)

          -  Current fish oil or lutein supplementation

          -  Allergy to soy
Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Voxilaprevir in Adults With Chronic Hepatitis C Virus Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Virus Diseases; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Voxilaprevir; Placebo to match voxilaprevir; SOF/VEL
Intervention description: Voxilaprevir tablets administered orally once daily; Placebo to match voxilaprevir tablets administered orally once daily; 400 mg/100 mg FDC tablet administered orally once daily
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Sustained Virologic Response; Direct Acting Antiviral; Combination Therapy; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Flaviviridae Infections; Antiviral Agents; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Antimetabolites; Molecular Mechanisms of Pharmacological Action

Summary:

      The primary objective of the study is to evaluate the safety and tolerability of voxilaprevir
      (formerly GS-9857) alone or with sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination
      (FDC) and antiviral activity of voxilaprevir in adults with genotype 1, 2, 3, 4 hepatitis C
      virus (HCV) infection. All participants will be monitored for up to 48 weeks after the last
      dose.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Chronic genotype 1-4 HCV infection

          -  For Cohorts 1-9, HCV RNA ≥ 100,000 IU/mL at screening (no HCV RNA restriction for
             Cohort 10)

          -  Screening laboratory values within defined thresholds

          -  Use of two effective contraception methods if female of childbearing potential or
             sexually active male

        Key Exclusion Criteria:

          -  Pregnant or nursing female or male with pregnant female partner

          -  Presence of cirrhosis

          -  Prior exposure to approved or experimental HCV Protease Inhibitors

          -  Co-infection with HIV or hepatitis B virus (HBV)

          -  Current or prior history of clinical hepatic decompensation

          -  Chronic use of systemic immunosuppressive agents

          -  History of clinically significant illness or any other medical disorder that may
             interfere with participant's treatment, assessment or compliance with the protocol

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
AG200-15 Transdermal Contraceptive Delivery System (TCDS) of Levonorgestrel and Ethinyl Estradiol
Condition: Healthy
Intervention: Ortho-Cyclen; AG200-15
Intervention description: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen.; AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE
Intervention MeSH terms: Moxifloxacin; Contraceptive Agents; Norgestimate, ethinyl estradiol drug combination; Contraceptives, Oral
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PK and safety; Pharmacokinetic profile (PK) and safety

Summary:

      Pharmacokinetics and safety of AG200-15 over two consecutive cycles of therapy will be
      evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy women, ages 18-45

          -  Body mass index (BMI) ≥18 and ≤32, and weight ≥ 110 lbs.

          -  Willing to use a non-hormonal method of contraception if at risk of pregnancy, OR have
             already undergone previous bilateral tubal ligation or hysterectomy

          -  Willing to refrain from use of alcohol and grapefruit juice from 48 hours prior until
             completion of each treatment period

        Exclusion Criteria:

          -  Known or suspected pregnancy;

          -  Lactating women

          -  Significant skin reaction to transdermal preparations or sensitivity to surgical /
             medical tape

          -  Any disease that may worsen under hormonal treatment (cardiovascular, liver,
             metabolic)

          -  Use of other contraceptive methods than study medication

          -  Smokers
To Compare the Pharmacokinetics and Safety of CT-P17 and Humira in Healthy Subjects
Condition: Healthy
Intervention: CT-P17; US-licensed Humira; EU-approved Humira
Intervention description: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS; 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS; 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
Intervention MeSH terms: Adalimumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 312.0
Sex: All
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 1, Randomized, Double-blind, Three-arm, Parallel group, Single-dose Study to
      Compare the Pharmacokinetics and Safety of CT-P17 and Humira (US licensed Humira and
      EU-approved Humira) in Healthy Subjects
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects

          -  BMI between 18.0 and 29.9 kg/m2, both inclusive, when rounded to the nearest tenth

        Exclusion Criteria:

          -  A medical history and/or condition that is considered significant

          -  Clinically significant allergic reactions, hypersensitivity

          -  History or current infection of hepatitis B virus (except for past resolved
             infection), hepatitis C virus, human immunodeficiency virus, or syphilis

          -  Active or latent Tuberculosis

          -  History of malignancy

          -  Previous monoclonal antibody or fusion protein treatment, or current use of any
             biologic

          -  Planning to be pregnant or father a child or donate sperm within 5 month after
             administration

          -  Undergone treatment with an investigational drug or participated in another clinical
             trial within 90 days or 5 half-lives (whichever is longer)
A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 2 Diabetes Mellitus (T2DM)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY900014; Insulin Lispro
Intervention description: Administered SC; Administered SC
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: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which
      is a drug that lowers blood sugar. The study will look at how the body processes LY900014,
      and the effect of LY900014 on blood sugar levels following a standard meal. For each
      participant, the study will consist of 4 periods and will last approximately 12 weeks from
      screening to final study follow up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a body mass index (BMI) of 18.5 kilogram per meter square (kg/m²) to 40.0 kg/m²

          -  Have a glycated hemoglobin (HbA1c) less than or equal to (≤)9.0%

          -  Have a fasting C-peptide ≤1.0 nanomole per liter (nmol/L)

          -  Are on stable prandial insulin and basal insulin (neutral protamine Hagedorn [NPH]
             insulin, insulin glargine or insulin detemir) with or without a stable dose of
             metformin for at least 3 months before screening

        Exclusion Criteria:

          -  Are currently enrolled, or have participated within the last 30 days, in a clinical
             trial or any other type of medical research

          -  Have or used to have health problems that, in the opinion of the doctor, could make it
             unsafe to participate in the study

          -  Have donated blood of more than 450 millilitre (mL) or more in the last 3 months or
             provided any blood donation within the last month before screening

          -  Any significant changes in insulin regimen and/or unstable blood glucose control
             within the past 3 months prior to screening as assessed by the investigator

          -  Are treated with a CSII (insulin pump)

          -  Require daily insulin treatment greater than (>)1.2 units per kilogram per body weight
             (U/kg/body weight)
DS-8201a in Patients With Cancer That Tests Positive for Human Epidermal Growth Factor Receptor 2 (HER2) Protein
Condition: Adenocarcinoma, Gastric; Neoplasm, Breast
MeSH terms: Adenocarcinoma; Breast Neoplasms
Intervention: DS-8201a
Intervention description: An antibody drug conjugate
Intervention MeSH terms: Trastuzumab deruxtecan
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Stomach cancer; Cancer where the esophagus meets the stomach; Human epidermal growth factor 2; HER2; Breast Cancer; Adenocarcinoma, Gastroesophageal Junction (GEJ); Gastric Cancer; Antibody drug conjugate (ADC); Oncology

Summary:

      HER2-positive cancer is a cancer that tests positive for a protein called human epidermal
      growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells. This study
      will test DS-8201a (trastuzumab deruxtecan), a HER2-targeted antibody and topoisomerase I
      inhibitor conjugate.

      The safety and tolerability profile of DS-8201a will be assessed in Chinese patients with
      certain types of stomach and breast cancer that test positive for HER2. It also will test how
      DS-8201a moves within the body (pharmacokinetics).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a pathologically documented unresectable or metastatic gastric or GEJ
             adenocarcinoma, or breast cancer, with HER2 expression [immunohistochemistry (IHC) 3+,
             2+, or 1+ and/or in situ hybridization (ISH) +] that is refractory to or intolerable
             with standard treatment, or for which no standard treatment is available

          -  Has a left ventricular ejection fraction (LVEF) ≥ 50%

          -  Has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1

        Exclusion Criteria:

          -  Has a medical history of myocardial infarction within 6 months before enrollment

          -  Has a medical history of ventricular arrhythmias, other than rare occasional premature
             ventricular contractions

          -  Has uncontrolled or significant cardiovascular disease

          -  Has any other history or condition that might compromise:

               1. Safety of the participant or offspring

               2. Safety of study staff

               3. Analysis of Results
Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674 (Cilofexor), and the Effect of Food on GS-9674 Pharmacokinetics and Pharmacodynamics
Condition: Nonalcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: Cilofexor; Placebo
Intervention description: Tablets administered orally; Tablets administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the safety and tolerability of escalating single- and multiple-oral
      doses of cilofexor, and characterize the single- and multiple-dose pharmacokinetics (PK) of
      cilofexor. The study will be conducted in 3 parts (Part A, Part B, and Part C). Participants
      will receive either cilofexor or cilofexor placebo.

      Part A will proceed in 4 prespecified staggered cohorts. Within each cohort, the cumulative,
      blinded safety data will be evaluated for dose escalation from single-dose (Period 1) to
      multiple-dose (Period 2). Based on the available safety, pharmacokinetics, and/or
      pharmacodynamics (PD) data from cohorts in Part A and Part C (if applicable), total daily
      doses and frequency of dosing will be chosen for the cohorts in Part B. Parts B and C will
      consist of adaptive cohorts and may be initiated in parallel. Part B cohorts may be initiated
      in parallel with cohorts in Part A if the total dose under evaluation is at or below a dose
      already evaluated.

      This study is partially blinded (no one is blinded on Day -1).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Healthy male and non-pregnant, non-lactating female volunteers

          -  Body mass index (BMI) 19 ≤ BMI ≤ 30 kg/m^2

          -  Normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered
             clinically insignificant by the investigator

          -  Normal renal function (estimated glomerular filtration rate calculated using the
             Cockcroft-Gault equation ≥ 80 mL/min)

          -  No significant medical history, and in good general health as determined by the
             investigator at screening evaluation performed no more than 28 days prior to the
             scheduled first dose.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study to Evaluate the Pharmacokinetics of Tenofovir Alafenamide (TAF) in Adults With Normal Hepatic Function and Adults With Severe Hepatic Impairment
Condition: Hepatitis B Virus
MeSH terms: Hepatitis B
Intervention: TAF
Intervention description: 25 mg tablet administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Severe Hepatic Impairment

Summary:

      The primary objective of this study is to evaluate the single-dose pharmacokinetics of
      tenofovir alafenamide (TAF) and its metabolite tenofovir (TFV) in participants with normal
      hepatic function and in participants with severe hepatic impairment.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Screening laboratory parameters within defined thresholds

          -  Creatinine clearance must be ≥ 60 mL/min

        Key Exclusion Criteria:

          -  Females who are pregnant or nursing or males who have a pregnant partner

          -  Infection with hepatitis B virus (HBV) or HIV

          -  History of clinically significant illness (including psychiatric or cardiac) or any
             other medical disorder that may interfere with participant treatment and/or adherence
             to the protocol

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
A Study of Vorinostat in Patients With Solid Tumors (MK-0683-029)
Condition: Tumors
MeSH terms: Neoplasms
Intervention: vorinostat
Intervention description: vorinostat 100 mg, 200 mg, 400 mg, or 500 mg single oral dose; once-daily or twice-daily administration
Intervention MeSH terms: Vorinostat
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Solid tumors

Summary:

      The primary purpose of this trial is to determine the maximum tolerated dose (MTD), or the
      maximum acceptable dose (MAD) and evaluate the dose limiting toxicity (DLT) of oral
      suberoylanilide hydroxamic acid in participants with solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with histologically or cytologically diagnosed solid tumor; no standard
             therapy available or participant has failed to respond to standard therapy

        Exclusion Criteria:

          -  Participants with history of immunotherapy, radiotherapy, surgery, or chemotherapy
             during the previous 4 weeks; previous treatment is 5 or more chemotherapeutic
             regimens.

          -  Any uncontrolled concomitant illness

          -  Are pregnant or breast-feeding

          -  Serious drug or food allergy