bioihbjkbjnl/mcl2 huggingface dataset:
Drug Interaction Study With Dabigatran Etexilate and Dronedarone in Healthy Subjects
Condition: Healthy
Intervention: Dabigatran etexilate plus dronedarone; Dabigatran etexilate; Dabigatran etexilate plus dronedarone; Dabigatran etexilate plus dronedarone; Dabigatran etexilate plus dronedarone
Intervention description: dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose; 150 mg as single dose; dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose (staggered administration); dabigatran etexilate 150 mg single dose plus dronedarone 400 mg bid; dabigatran etexilate 150 mg single dose plus dronedarone 400 mg bid (staggered administration)
Intervention MeSH terms: Dronedarone; Dabigatran
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the study is to assess the relative bioavailability of a single dose of
      dabigatran after concomitant multiple oral administration of dronedarone with the aim to
      investigate whether and to what extent the P-gp inhibitor dronedarone affects pharmacokinetic
      parameters of dabigatran when administered to healthy subjects
    

Eligibility criteria:

        Inclusion criteria:

        1. Healthy male and female subjects

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions
A Study of the Effect of Abemaciclib on Metformin and Iohexol in Healthy Participants
Condition: Healthy
Intervention: Abemaciclib; Metformin; Iohexol; Placebo
Intervention description: Administered orally; Administered orally; Administered intravenously (IV); Administered orally
Intervention MeSH terms: Metformin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will look at how a single dose of abemaciclib will impact the body's ability to
      get rid of two other drugs, metformin and iohexol. In addition, this study will evaluate the
      effect of a single dose of abemaciclib on kidney function by measuring blood and urine
      markers. Side effects will also be documented.

      Each participant will complete four study periods. During each study period, participants
      will stay in the clinical research unit for nine days and eight nights.

      The study will last approximately 10 weeks, not including screening. Screening is required
      within 28 days prior to the start of the study.

      This study is for research purposes only and is not intended to treat any medical condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy surgically sterile or postmenopausal females and sterile males

          -  Have a body mass index (BMI) between 18 and 32 kilograms per meter squared (kg/m²),
             inclusive at screening

        Exclusion Criteria:

          -  Have known allergies to abemaciclib, metformin, iodine, iohexol, related compounds, or
             any components of the formulation

          -  Regularly use known drugs of abuse and/or show positive findings on urinary drug
             screening

          -  Show evidence and/or positive antibodies of human immunodeficiency virus (HIV),
             hepatitis B, or hepatitis C
Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular Degeneration
Condition: Age-Related Maculopathy; Age-Related Maculopathies; Eye Diseases; Retinal Degeneration; Macular Degeneration
MeSH terms: Macular Degeneration; Eye Diseases; Retinal Degeneration
Intervention: RN6G; Placebo
Intervention description: intravenous, single dose, dose ranging from 0.3mg/kg up to a maximum of 40 mg/kg.; intravenous, single dose with experimental dose.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phase 1; Dry Age Related Macular Degeneration; RN6G

Summary:

      The purpose of this study is to determine the safety and tolerability of RN6G in patients
      with dry, age-related macular degeneration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be of non-childbearing potential.

          -  Diagnosis of dry AMD as defined by the Age-Related Eye Disease Study (AREDS, 2005),
             including uni- or multi-focal GA, without foveal involvement.

          -  BCVA of 20/320 or better in the worst eye.

        Exclusion Criteria:

          -  Diagnosis of exudative (wet) AMD, with subretinal or choroidal neovascular lesions.

          -  Diagnosis or history of Alzheimer's disease, dementia or neurodegenerative disorders.

          -  Diagnosis or recent history of clinically significant cerebrovascular disease.

          -  Uncontrolled hypertension.

          -  Uncontrolled Type 1 or Type 2 diabetes mellitus.
A Drug Interaction Study of SPD503 and Vyvanse Administered Alone and In Combination in Normal Healthy Volunteers
Condition: Healthy
Intervention: SPD503; VYVANSE; SPD503 and VYVANSE
Intervention description: SPD503 extended-release 4mg orally administered tablets. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken.; VYVANSE 50mg orally administered capsules. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken.; SPD503 4mg tablets + VYVANSE 50mg capsules orally administered together. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken.
Intervention MeSH terms: Guanfacine; Lisdexamfetamine Dimesylate
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Normal, healthy volunteers (for this Phase 1 study)

Summary:

      Drug-drug interaction study; to examine the pharmacokinetics of SPD503 and VYVANSE
      (lisdexamfetamine dimesylate) when given alone, and in combination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be normal healthy adult volunteers (with no significant abnormalities in
             medical history, physical exam, vital signs or lab evaluations at screening) in order
             to be eligible to participate.
A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer
Condition: Prostate Cancer; Hormone Refractory Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: MDV3100
Intervention description: MDV3100 daily until progression or dose-limiting toxicity
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 140.0
Sex: Male
Healthy volunteers: No
Keywords: Prostate; Cancer; Hormone; Refractory; Castration

Summary:

      This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to
      treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional
      patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients
      who tolerate the drug and do not progress will be allowed to continue to look for PSA
      response.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or cytologically confirmed adenocarcinoma of the prostate;

          2. Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH)
             analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration);

          3. Progressive disease after medical or surgical castration,

        Exclusion Criteria:

        1. Metastases in the brain or active epidural disease. (Note: patients with treated
        epidural disease are allowed);
A Dose-finding Study of Dalotuzumab in Subjects With Advanced Solid Tumors (MK-0646-002)
Condition: Advanced Solid Tumors
Intervention: dalotuzumab
Intervention description: Administered as an IV infusion over one to two hours
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study determined the recommended Phase 2 loading and maintenance doses and dose schedules
      for administering dalotuzumab using dose-limiting toxicities (DLTs) observed during the
      entire treatment period (Up to 18 months). The primary hypothesis of the study was that
      administration of dalotuzumab as an every other week infusion in participants with relapsed
      or refractory locally advanced or metastatic cancers associated with a high frequency of
      insulin-like growth factor receptor type 1(IGF-1R) overexpression will be generally safe and
      well tolerated to permit further study and achieve a constant clearance and a minimum trough
      concentration of 3 µg/mL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females with advanced solid tumors who have failed to respond to standard
             therapy, ages 18 years and older, with adequate organ function

        Exclusion Criteria:

          -  Participant is using growth hormones or growth hormone inhibitors

          -  Participant is known to be allergic to components of the drug or similar drugs (e.g.
             monoclonal antibodies such as rituximab or biological therapies such as immunoglobulin
             G

          -  Participant has had chemotherapy, radiotherapy, or biological therapy within 4-6 weeks
             of entering the study or has not recovered from previous therapy

          -  Participant is taking part in or has taken part in a study of an investigational
             compound or device within 30 days of their first dose of study drug

          -  Participant has an active Central Nervous System metastases and/or carcinomatous
             meningitis. However, a participant who has completed a course of therapy and is
             clinically stable may be able to participate

          -  Participant is pregnant or breastfeeding

          -  Participant is human immunodeficiency virus (HIV) positive

          -  Participant has a history of Hepatitis B or C

          -  Participant has symptomatic ascites or pleural effusion. However, if the participant
             has received treatment and is stable, they may be able to participate

          -  Female participant plans to become pregnant or a male participant who plans to
             impregnate their partner during the time the study is ongoing
A Study Investigating the Absolute Oral Bioavailability of Balovaptan After Single and Multiple Daily Oral Doses of Balovaptan in Healthy Volunteers
Condition: Healthy Volunteers
Intervention: Oral Balovaptan; IV Balovaptan
Intervention description: In Period 1, balovaptan was administered as a single oral dose.
In Period 2, balovaptan was administered as an oral dose once daily on Day 1 to Day 14.; In Period 1, IV infusion of balovaptan was administered after the balovaptan oral dose.
In Period 2, IV infusion of balovaptan was administered after the final oral dose of balovaptan.
Intervention MeSH terms: Balovaptan
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: Accepts Healthy Volunteers

Summary:

      This study was a non-randomized, open-label, parallel group, two-treatment study in healthy
      volunteers to investigate the absolute oral bioavailability of balovaptan. 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.
To Evaluate the Pharmacokinetic of Diacerein and Rhein After Maximum Use in Patients With Epidermolysis Bullosa (EB)
Condition: Epidermolysis Bullosa (EB); Epidermolysis Bullosa Simplex; Dystrophic Epidermolysis Bullosa; Junctional Epidermolysis Bullosa
MeSH terms: Epidermolysis Bullosa; Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa Simplex; Epidermolysis Bullosa, Junctional
Intervention: Diacerein 1% Ointment
Intervention description: Diacerein 1% Ointment administered topically
Intervention MeSH terms: Diacerein
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 4 Years
Healthy volunteers: No
Keywords: EB; EBS; DEB; JEB

Summary:

      A pharmacokinetic (PK) study in 16-20 EB subjects to be allocated to two cohorts. Cohort 1 to
      include 8-10 subjects (ages 12 yrs and older); Cohort 2 to include 8-10 subjects (ages 6
      months-11 yrs, inclusive). Cohort 2 only included subjects 4 yrs and older. Serial PK blood
      sampling collected on Days 1 and 10. Analyses were performed to determine the concentrations
      of diacerein and rhein.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  At least 12 years of age (Cohort 1) or at least 6 months of age to 11 years, inclusive
             (Cohort 2) at screening. For US only: at least 4 years of age to 11 years, inclusive
             (Cohort 2)

          -  The subject must weigh at least 9 kg (19.8 lbs) at Screening.

          -  Subject has a documented genetic mutation consistent with EB.

          -  Subject has EB lesions on ≥ 2% body surface area (BSA) and the EB lesions are in the
             following body areas: a. Localized: plantar and/or palmar areas, b. Generalized: arms,
             legs, torso, hands and feet.

        Key Exclusion Criteria:

          -  Subject has EB lesions where drug will be applied that are infected

          -  Subject has used any diacerein containing product within 1 month prior to Visit 1

          -  Subject has used systemic immunotherapy or cytotoxic chemotherapy within 60 days prior
             to dosing.

          -  Subject has used systemic steroidal therapy or has used topical steroidal therapy on
             the EB lesions in the application area within 14 days prior to dosing

          -  Subject has participated in an investigational drug trial in which administration of
             an investigational study medication occurred within 30 days prior to dosing
Safety And Tolerability Of Escalating Intravenous Doses Of PF-05231023 In Adult Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: PF-05231023; PF-05231023; PF-05231023; PF-05231023; PF-05231023; PF-05231023; PF-05231023; Placebo
Intervention description: 0.5 mg QD IV x 1 day; 1.5 mg QD IV x 1 day; 5 mg QD IV x 1 day; 15 mg QD IV x 1 day; 50 mg QD IV x 1 day; 100 mg QD IV x 1 day; 200 mg QD IV x 1 day; 0.9% w/v sodium chloride injection, USP QD IVx 1 day
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 84.0
Sex: All
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Type 2 diabetes; intravenous; single dose

Summary:

      This is a trial in subjects with Type 2 diabetes mellitus to study the safety, tolerability
      and pharmacokinetics and pharmacodynamics of single escalating doses of PF-05231023.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects between the ages of 30 and 65 years, inclusive, with a
             historical diagnosis of type 2 diabetes mellitus, diagnosed according to the American
             Diabetes Association guidelines.

          -  Body Mass Index (BMI) of 25 to 35.5 kg/m2, and a total body weight >50 kg (110 lbs).

          -  HbA1c >7% and not to exceed 10.5%.

        Exclusion Criteria:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
             allergic disease (including drug allergies, but excluding untreated, asymptomatic,
             seasonal allergies at time of dosing).

          -  Diagnosis of Type 1 diabetes mellitus

          -  Evidence of diabetic complications with significant end organ damage.
Safety and Tolerability of MK-5478 in Participants With Hypertension (5478-001)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: MK-5478; Comparator: Candesartan cilexetil; Comparator: Pbo
Intervention description: In Part I: Single dose administration of MK-5478 oral capsules, total doses of 1, 2, 5, 8, 12, 18, 24 or 38 mg.; Single dose administration of candesartan, 32 mg oral tablet; Placebo
Intervention MeSH terms: Candesartan; Candesartan cilexetil
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a two part introductory clinical trial with MK-5478. Part I will evaluate the safety,
      tolerability and pharmacokinetics and pharmacodynamics of MK-5478 in young, healthy males.
      Part II will evaluate the safety, tolerability and pharmacodynamic effects of MK-5478 in
      participants with hypertension. The primary hypothesis is that single oral doses of MK-5478
      are sufficiently safe and well tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

        Part I:

          -  Is a male between 18 to 50 years of age

          -  Is in good health

          -  Is a non-smoker

        Part II:

          -  Is male of non-child bearing potential between 18 and 50 years of age

          -  Has hypertension (high blood pressure)

        Exclusion Criteria:

        Part I and Part II:

          -  Has a history of stroke, seizures or major neurological disorder

          -  Has a history of cancer

          -  Has a history of any cardiovascular disease

          -  Is unable to refrain from the use of any prescription or non-prescription drugs

          -  Consumes excessive amounts of alcohol or caffeine

          -  Has had major surgery, donated blood or participated in another investigational study
             in the past 4 weeks
A Study of Various Formulations of LY900014 in Healthy Participants
Condition: Healthy
Intervention: LY900014; Insulin lispro (Humalog)
Intervention description: Administered subcutaneously (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: Single (Participant)
Enrollment: 26.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate how quickly the body absorbs, breaks down, and gets rid of the
      different formulations of LY900014. This study will determine how the different formulations,
      when injected under the skin, will affect the blood sugar levels in the body, and how safe it
      is.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy male or a female (not pregnant and agreeable to take birth control
             measures until one month after study completion)

          -  Must have a body mass index (BMI) of 18.0 to 30 kilogram per square meter (kg/m²)
             (inclusive) at the time of study screening

          -  Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine
             laboratory test results that are acceptable for the study

          -  Are non-smokers or have not smoked for at least 2 months prior to entering the study,
             and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the
             duration of the study

          -  Have veins suitable for easy blood collection and glucose solution infusion

        Exclusion Criteria:

          -  Have known allergies to insulin lispro or compounds related to these drugs, or any
             components of the study drug

          -  Show signs of having an infection or infectious disease at the time of study entry