bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection.
Condition: HIV Infections
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Intervention: Ritonavir; saquinavir [Invirase]
Intervention description: 100mg po bid; 1000mg po bid
Intervention MeSH terms: Ritonavir; Saquinavir
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Treatment Naive

Summary:

      This 2 arm study will assess the effect of moderate liver impairment on the pharmacokinetics
      of saquinavir and ritonavir at steady state following administration of saquinavir/ritonavir
      1000mg/100mg po bid in HIV patients. Saquinavir/ritonavir will be administered concomitantly
      with 2 to 3 active nucleoside reverse transcriptase inhibitors. The study will compare a
      group of HIV patients without known liver disease and a group with moderate liver disease.
      The anticipated time on study treatment is <3 months, and the target sample size is <100
      individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, 18-65 years of age;

          -  HIV infection;

          -  normal liver function, or moderate liver disease (Child-Pugh grade B);

          -  antiretroviral therapy naive and eligible to take antiretroviral treatment as per
             treatment guidelines, or treatment experienced for at least 4 weeks prior to first
             dosing.

        Exclusion Criteria:

          -  severe ascites at screening, or Child-Pugh grade C;

          -  acute infection or current malignancy requiring treatment;

          -  taking any inhibitor of CYP3A4 (with the exception of anti-HIV drugs) within 14 days
             prior to first dosing;

          -  taking any inducer of CYP3A4 (with the exception of anti-HIV drugs) within 4 weeks
             prior to pharmacokinetic evaluation (day 14 or 28);

          -  evidence of resistance to saquinavir.
Extended Use Protocol for Participants With Cancer to Receive Continued Treatment With CS-7017
Condition: Advanced Cancer
Intervention: CS-7017
Intervention description: CS-7017 administered orally, twice daily continuously for 6 weeks
Intervention MeSH terms: Efatutazone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Healthy volunteers: No
Keywords: CS-7017; Advanced Cancer

Summary:

      This is a study of CS-7017 designed to allow participants who completed participation in a
      clinical study of CS-7017 without experiencing disease progression or unacceptable toxicity
      to continue treatment with study drug. Participants who have not progressed while receiving
      CS-7017 will continue to benefit from longer administration of the agent.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant previously treated with CS-7017 as part of a study that included CS-7017
             and has shown clinical benefits from treatment with CS-7017.

        Exclusion Criteria:

          -  Anticipation of need for a major surgical procedure or radiation therapy during the
             study.

          -  Any of the following conditions within 6 months prior to initiating study treatment:
             Myocardial infarction with significant impairment of cardiac function (eg, ejection
             fraction ≤ 50%), severe/unstable angina pectoris, coronary/peripheral artery bypass
             graft, New York Heart Association (NYHA) class II or higher congestive heart failure.

          -  Participants with clinically significant pleural or pericardial effusions.

          -  Clinically significant active infection, which requires antibiotic therapy, or human
             immune deficiency virus (HIV)-positive subjects receiving antiretroviral therapy.

          -  Participants with diabetes mellitus requiring treatment with insulin, sulfonylureas or
             thiazolidinediones (TZDs) agents, malabsorption syndrome, chronic diarrhea,
             inflammatory bowel disease, or partial bowel obstruction.
Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Intervention: PF-07321332; Ritonavir
Intervention description: Tablet; PK Boosting agent
Intervention MeSH terms: Ritonavir; Nirmatrelvir
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: COVID-19; SARS-CoV-2

Summary:

      The study is to estimate the effect of hepatic impairment on the plasma PK of
      PF-07321332/ritonavir. Findings from this study will be used to develop dosing
      recommendations so that the dose and/or dosing interval may be adjusted appropriately in the
      presence of hepatic impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female participants who are classically healthy having no clinically relevant
             abnormalities. No known or suspected hepatic impairment

          -  Stable hepatic impairment that meets the criteria for Class B of the Child-Pugh
             Classification

        Exclusion Criteria:

          -  Any condition possibly affecting drug absorption (eg, prior bariatric surgery,
             gastrectomy, ileal resection).

          -  Participants who have been vaccinated with COVID-19 vaccines within the past week of
             dosing

          -  A positive urine drug test, for illicit drugs, at Screening

          -  History of sensitivity reactions to ritonavir or any of the formulation components of
             PF-07321332 or ritonavir.

          -  eGFR <60 mL/min/1.73m2 based on the Chronic Kidney Disease-Epidemiology Collaboration
             (CKD-EPI) equation

          -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≥ upper limit
             of normal (ULN) (for healthy participants); AST or ALT > 5x ULN (for hepatic
             impairment participants)

          -  Albumin > ULN (for healthy participants);

          -  Prothrombin time > ULN (for healthy participants);

          -  Total bilirubin level ≥1.5 × ULN [NOTE: Participants with a history of Gilbert
             syndrome (and hence elevated total bilirubin) are eligible provided direct bilirubin
             level is ≤ ULN).
Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fasted Male.
Condition: Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: tamsulosin capsules; tamsulosin HCl
Intervention MeSH terms: Tamsulosin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: Male
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A bio-equivalence of 2 different capsule formulations in fasted subjects
    

Eligibility criteria:

        Inclusion criteria:

        Healthy male volunteers 18 years and older

        Exclusion criteria:

        History of hypersensitivity or allergy to the IPM or its excipients or any related
        medication
Ascending Multiple-Doses of Erenumab (AMG 334) in Healthy Adults and in Migraine Patients
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Erenumab; Placebo
Intervention description: Administered by subcutaneous injection once a month; Administered by subcutaneous injection once a month
Intervention MeSH terms: Erenumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Migraine

Summary:

      The primary purpose of this study is to determine whether erenumab is safe and well tolerated
      in healthy adults and migraine patients. As part of the secondary objectives, this study will
      be conducted to characterize the pharmacokinetic (PK) profile of erenumab after multiple
      subcutaneous (SC) doses in healthy adults and migraine patients, as well as to characterize
      the effect of erenumab on the capsaicin induced increase in dermal blood flow after multiple
      SC doses in healthy adults and migraine patients.
    

Eligibility criteria:

        Inclusion Criteria:

        Healthy male and female subjects, as well as male or female subjects with migraines between
        18 and 55 years of age, inclusive, with no history or evidence of clinically relevant
        medical disorders as determined by the investigator in consultation with the Amgen
        physician;

        Exclusion Criteria:

        - History or evidence of clinically significant disorder (including psychiatric), condition
        or disease that, in the opinion of the Investigator or Amgen physician would pose a risk to
        subject safety or interfere with the study evaluation, procedures, or completion;
Bioavailability Study of Colcrys® in Apple Juice
Condition: Healthy
Intervention: colchicine 0.6 mg tablet; colchicine 0.6 mg tablet
Intervention description: One Colcrys® 0.6 mg intact tablet taken by mouth; One Colcrys® 0.6 mg tablet dissolved in apple juice
Intervention MeSH terms: Colchicine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: bioavailability

Summary:

      The purpose of this study is to evaluate and compare the relative bioavailability of a single
      0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and dissolved in apple juice
      relative to the same dose given as an intact tablet to healthy subjects following an
      overnight fast.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults age 18-55, non-smoking, non- pregnant (post-menopausal, surgically
             sterile or using effective contraceptive measures) with a body mass index of 18-30
             kg/m²

        Exclusion Criteria:

          -  Recent participation (within 30 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)

          -  History of treatment for drug or alcohol addiction within the previous 12 months or
             use of tobacco products within 90 days of the start of the study

          -  Significant history or current evidence of chronic infectious disease, system
             disorders, organ dysfunction, especially cardiovascular disorders (angina, heart
             failure, irregular heartbeats, heart attack, hypertension, hypotension) stroke, renal
             or hepatic disorders, diabetes or bleeding disorders, gastrointestinal disease or
             history of malabsorption within the last year

          -  History of or psychiatric disorders occurring within the last two years that required
             hospitalization or medication

          -  Presence of a medical condition requiring regular treatment with prescription drugs

          -  Use of any drugs or substances known to inhibit or induce drug-metabolizing enzymes
             within 30 days prior to dosing with the study drug

          -  Drug allergies or sensitivity to colchicine

          -  Positive test results for drugs of abuse at screening
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.
Fasted Bioequivalence Study of Primidone Tablets and Mysoline Tablets
Condition: Therapeutic Equivalency
Intervention: Primidone 50 mg Tablet; Primidone (Mysoline®) 50 mg Tablet
Intervention description: 50 mg tablet administered after an overnight fast of at least 10 hours.; 50 mg tablet administered after an overnight fast of at least 10 hours.
Intervention MeSH terms: Primidone
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the bioequivalence of a test formulation of primidone
      tablets to an equivalent oral dose of the commercially available Mysoline®(primidone tablets)
      in adult subjects under fasting conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female

          -  at least 18 years of age

          -  weight must be 15% of ideal weight for height and frame

          -  subjects must be in good health and physical condition as determined by medical
             history

          -  subjects must read and sign consent form

        Exclusion Criteria:

          -  history of treatment for alcoholism, substance abuse, or drug abuse within the last 24
             months

          -  history of malignancy, stroke, diabetes, cardiac, renal or liver disease

          -  history of gastroesophageal reflux disease (GERD), malabsorption syndrome, colon
             cancer, chronic colitis, including Crohn's disease

          -  history of porphyria, hyperkinesia, respiratory diseases (eg. asthma, emphysema,
             difficulty breathing, pulmonary obstruction)

          -  females who pregnant or lactating

          -  history of hypersensitivity to primidone, barbiturates, and anticonvulsants

          -  sitting systolic blood pressure below 90mm Hg, or diastolic pressure below 50mm Hg
             (conditions upon screening which might contraindicate or require that caution be used
             in the administration of primidone)

          -  heart rate less than 50 beats per minute after a 5 minute rest

          -  treatment with any other investigational drug during the four weeks prior to initial
             dosing

          -  subjects who have donated blood within four weeks prior to the initial dosing

          -  subjects who smoke or use tobacco products or nicotine products. Three months
             abstinence is required.
A Study to Investigate the Effect of Itraconazole on the PK of Multiple Doses of Balovaptan in Healthy Volunteers
Condition: Healthy Volunteers
Intervention: Balovaptan; Itraconazole
Intervention description: In Period 1, balovaptan was administered orally once daily (qd) on Days 1 to 10.
In Period 2, balovaptan was administered qd on Days 6 to 20.; In Period 2, 200 mg itraconzole was administered bid for 4 days and qd on Days 5-20, approximately 12 hours apart. On Days 6-20, 200 mg itraconazole was administered qd.
Intervention MeSH terms: Itraconazole; Balovaptan
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study was a non-randomized, open-label, one-sequence, two-period within-subject study to
      investigate the effect of CYP3A inhibition on the PK of balovaptan in healthy male and female
      volunteers using itraconazole as a CYP3A inhibitor. The study was conducted at 1 site in the
      Netherlands.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and female subjects. Healthy status is defined by absence of evidence of
             any active or chronic disease following a detailed medical and surgical history, a
             complete physical examination including vital signs, 12-lead ECG, hematology, blood
             chemistry, urinalysis, and serology.

          -  Body Mass Index of 18 to 30 kg/m2, inclusive.

          -  For women of childbearing potential: agreement to use at least 2 acceptable
             contraceptive methods during the treatment period and for 90 days after the last dose
             of study drug.

          -  For men: agreement to use contraceptive measures, and agreement to refrain from
             donating sperm until 90 days after the last dose of study drug.

        Exclusion Criteria:

          -  Female subjects who are pregnant or lactating.

          -  Any condition or disease detected during the medical interview/physical examination
             that would render the subject unsuitable for the study, place the subject at undue
             risk or interfere with the ability of the subject to complete the study in the opinion
             of the Investigator.
Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia
Condition: Alopecia; Alopecia, Androgenetic; Baldness
MeSH terms: Alopecia; Alopecia Areata
Intervention: bimatoprost Formulation A; bimatoprost Formulation B; bimatoprost Formulation C
Intervention description: bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.; bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.; bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
Intervention MeSH terms: Bimatoprost
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      This study will investigate the safety, tolerability, and pharmacokinetics of new formulation
      of bimatoprost following topical application in patients with alopecia. Two formulations of
      bimatoprost will be investigated in Part 1 and a third formulation of bimatoprost will be
      investigated in Part 2. Part 2 will begin after Part 1 has completed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males with moderate male-pattern baldness (androgenic alopecia)

          -  Females with moderate female pattern hair loss

          -  Non-smoker or smoker with at least 30 days abstinence from smoking/using
             nicotine-containing products

        Exclusion Criteria:

          -  Any dermatological condition of the scalp other than androgenic alopecia (males) or
             female pattern hair loss (females)

          -  Use of bimatoprost or other prostaglandin analogs within 3 months

          -  Prior use of scalp hair growth treatment (eg, finasteride, minoxidil) within 6 months

          -  Any prior hair growth procedures (eg, hair transplant or laser)

          -  Blood donation or equivalent blood loss within 90 days

          -  History of alcohol or drug addiction