bioihbjkbjnl/mcl2 huggingface dataset:
Bioavailability Study of Colcrys® Crushed and Sprinkled on Applesauce
Condition: Healthy
MeSH terms: Crush Injuries
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 crushed and sprinkled on applesauce
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 sprinkled on applesauce (1
      tablespoon) relative to the same dose given as an intact tablet to healthy subjects following
      an overnight fast. A secondary objective is to evaluate the safety and tolerability of this
      regimen in healthy volunteers. All study subjects will be monitored for adverse events
      throughout the study period.
    

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 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
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1015550 in Healthy Male Volunteers
Condition: Healthy
Intervention: BI 1015550; BI 1015550; BI 1015550; BI 1015550; BI 1015550; Placebo; BI 101550; BI 1015550; BI 1015550; BI 1015550
Intervention description: High dose powder for oral solution; Medium dose powder for oral solution; Low dose powder for oral solution; Low dose powder for oral solution; Low dose powder for oral solution; Solution for oral administration; High dose powder for oral solution; Low dose powder for oral solution; Medium dose powder for oral solution; Medium dose powder for oral solution
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Enrollment: 70.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      In this first-in-man trial, safety, tolerability, pharmacokinetics, and selected
      pharmacodynamics parameters of BI 1015550 will be assessed in healthy male volunteers.
    

Eligibility criteria:

        Inclusion criteria:

        1. Healthy male subjects

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions
To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI)
Condition: Complicated Infection; Bacterial Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections
Intervention: Avibactam (AVI); Aztreonam (ATM); combination of Aztreonam - Avibactam (ATM-AVI); Placebo
Intervention description: PART A: AVI IV infusion; PART A: ATM IV infusion; PART A: ATM-AVI IV infusion. PART B and C: ATM-AVI IV infusions.; PART A, PART B, PART C: matching placebo IV infusions
Intervention MeSH terms: Aztreonam; Avibactam
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 222.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Phase I, Safety, tolerability, healthy.

Summary:

      This is a randomised, double-blind, 3-part study designed to investigate the safety and
      tolerability of ATM-AVI. The study aims to characterise the pharmacokinetics of ATM-AVI, when
      both drugs are administered alone (ATM or AVI) and in combination (ATM-AVI), following single
      administration, and following multiple administrations of ATM-AVI in healthy male and female
      (females of nonchildbearing potential) volunteers both young and elderly.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed and dated, written informed consent prior to any study specific
             procedures

          -  Healthy young male and female volunteers aged 18 to 45 years (inclusive) and healthy
             elderly volunteers aged 65 or older (Part C) with suitable veins for cannulation or
             repeated venipuncture

          -  Have a body mass index (BMI) between 19 and 30 kg/m2

          -  Be able to understand and willing to comply with study procedures, restrictions, and
             requirements, as judged by the PI

        Exclusion Criteria:

          -  History of any clinically significant disease or disorder which, in the opinion of the
             PI, may either put the volunteer at risk because of participation in the study, or
             influence the results or the volunteer's ability to participate in the study

          -  History or presence of gastrointestinal, hepatic, or renal disease, or any other
             condition known to interfere with absorption, distribution, metabolism, or excretion
             of drugs

          -  Known history of severe allergy to betalactam and/or L-arginine

          -  History of severe allergy/hypersensitivity or ongoing clinically important
             allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs
             with a similar chemical structure or class to ATM or AVI

          -  Any clinically significant illness, medical/surgical procedure, or trauma within 4
             weeks prior to the first administration of IP
A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0973 in Combination With GDC-0068 When Administered in Participants With Locally Advanced or Metastatic Solid Tumors
Condition: Neoplasms
Intervention: Ipatasertib; Cobimetinib
Intervention description: multiple doses; multiple doses
Intervention MeSH terms: Ipatasertib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: GDC0973; MEK; MEK inhibitor; GDC0068; Akt; Akt inhibitor

Summary:

      This open-label, multicenter, Phase Ib dose-escalation study will evaluate the safety,
      tolerability and pharmacokinetics of oral dosing of GDC-0973 and GDC-0068 administered in
      combination in patients with locally advanced or metastatic solid tumors. Cohorts of patients
      will receive multiple ascending doses of GDC-0973 and GDC-0068. Anticipated time on study
      treatment is until disease progression or unacceptable toxicity occurs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically documented locally advanced or metastatic solid tumors
             for which standard therapies either do not exist or have proven ineffective or
             intolerable

          -  Evaluable disease or disease measurable per Response Evaluation Criteria in Solid
             Tumors (RECIST)

          -  Life expectancy >/= 12 weeks

          -  Adequate hematologic and end organ function

        Exclusion Criteria:

          -  History of prior significant toxicity from another MEK pathway inhibitor requiring
             discontinuation of treatment

          -  History of prior significant toxicity from another phosphoinositide 3-kinase (PI3K) or
             Akt pathway or mammalian target of rapamycin (mTOR) inhibitor requiring
             discontinuation of treatment

          -  Anti-cancer therapy within 28 days prior to first dose of study drug, except as stated
             in protocol

          -  History of type I or type II diabetes mellitus requiring insulin

          -  Current severe, uncontrolled systemic disease (e.g. clinically significant
             cardiovascular, pulmonary, or metabolic disease)

          -  Clinically significant history of liver disease, current alcohol abuse, or current
             known active infection with HIV, hepatitis B or hepatitis C virus

          -  Active autoimmune disease

          -  Pregnant or lactating women

          -  Known brain metastases that are untreated, symptomatic, or require therapy to control
             symptoms

          -  History of glaucoma

          -  History of retinal vein occlusion
Safety and Pharmacokinetics of Intravenous and Oral Posaconazole in Immunocompromised Children (MK-5592-097)
Condition: Neutropenia
MeSH terms: Neutropenia
Intervention: Posaconazole IV solution; Posaconazole powder for oral suspension
Intervention description: Posaconazole by IV solution twice on Day 1, then once daily on Days 2-10.; Posaconazole once daily by PFS for a minimum of 10 days
Intervention MeSH terms: Posaconazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 118.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study aims to evaluate the pharmacokinetics of posaconazole (POS) administered
      intravenously (IV) or orally to immunocompromised pediatric participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have documented or anticipated neutropenia expected to last for at least 7 days,
             following treatment in at least one of the following clinical situations: acute
             leukemia, myelodysplasia, severe aplastic anemia, recipients of Autologous
             Hematopoietic Stem Cell Transplant (HSCT), high risk neuroblastoma, advanced stage
             non-Hodgkin's lymphoma, hemophagocytic lymphohistiocytosis

          -  Have a central line in place prior to IV study therapy

          -  Participants of reproductive potential agree to remain abstinent, or use a medically
             accepted method of birth control

        Exclusion Criteria:

          -  Has a proven or probable invasive fungal infection

          -  Has received any formulation of POS within prior 10 days

          -  Is receiving any prohibited drugs

          -  Has laboratory results that are outside of normal limits at screening, as follows: a)
             Moderate or severe liver dysfunction, as defined as: Aspartate Aminotransferase (AST)
             > 5 times the upper limit of normal (ULN), OR Alanine Aminotransferase (ALT) > 5 times
             the ULN, OR Serum total bilirubin >2.5 times the ULN, OR AST or ALT > 3 times ULN with
             total bilirubin > 2 times ULN; b) Calculated creatinine clearance <30 mL/min.

          -  Has QTc (QT interval corrected for rate) prolongation defined as: a) Symptomatic QTc
             prolongation >450 msec (males) or >470 msec (females) OR b) Any QTc prolongation of
             >500 msec

          -  Is pregnant, intends to become pregnant during study, or is breastfeeding

          -  Has a history of anaphylaxis attributed to the azole class of antifungal agents

          -  Is not expected to receive a minimum of 10 days of POS IV solution

          -  Has participated in any Phase 1 Investigational New Drug (IND) study within prior 30
             days or expects to do so within the following 60 days

          -  Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or
             child) who is investigational site or sponsor staff directly involved with this trial
A Phase I/II Clinical Study of SK&F-105517-D in Japanese Patients With Chronic Heart Failure
Condition: Heart Failure, Congestive
MeSH terms: Heart Failure
Intervention: SK&F-105517-D 10 mg capsule; Carvedilol-immediate release (IR) 2.5 mg tablet; SK&F-105517-D 20 mg capsule; SK&F-105517-D 40 mg capsule; Carvedilol-IR 10 mg tablet
Intervention description: 1 capsule once a day; 1 or 2 tablet(s) twice a day; 1 capsule once a day; 1 or 2 capsule(s) once a day; 1 tablet twice a day
Intervention MeSH terms: Carvedilol
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: carvedilol phosphate; ß-blocker; SK&F-105517-D; Chronic heart failure(CHF)

Summary:

      The primary objective of this study is to evaluate the safety and tolerability of
      SK&F-105517-D in japanese patients with chronic heart failure.
    

Eligibility criteria:

        Inclusion criteria:

          -  Patients with symptomatically stable chronic heart failure (CHF) based on ischemic
             heart disease or dilated cardiomyopathy

          -  Patients who are maintained on basic heart failure therapy with angiotensin converting
             enzyme (ACE) inhibitors or angiotensin II receptor blocker (ARB) and their
             dosage/administration is not changed within 2 weeks

          -  Patients diagnosed with New York Heart Association (NYHA) class I to III

          -  Patients with a left ventricular ejection fraction (LVEF) between 25% and 45%

        Exclusion Criteria:

          -  Patients contraindicated for ß-blockers

          -  Patients with occurrence of acute myocardial infarction within 2 weeks

          -  Patients with unstable angina, coronary spastic angina, or angina at rest

          -  Patients who have collected blood >400 mL within 4 months prior to screening or >200
             mL within 1 months
Relative Bioavailability of Empagliflozin (BI 10773) and Ramipril Administered Together Compared to Empagliflozin (BI 10773) and Ramipril Alone in Healthy Volunteers
Condition: Healthy
Intervention: BI 10773; Ramipril; BI 10773; Ramipril; Ramipril; Ramipril
Intervention description: medium dose, oral administration; Medium dose oral administration on day 2-5; medium dose oral administration; Low dose oral administration on day 1; Low dose oral administration on day 1; Medium dose oral administration on day 2-5
Intervention MeSH terms: Empagliflozin; Ramipril
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Primary objective:To investigate if BI 10773 affects the pharmacokinetics of ramipril and if
      ramipril affects the pharmacokinetics of BI 10773.
    

Eligibility criteria:

        Inclusion criteria:

        1. healthy male and female subjects

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions.
A Single-Dose Study of the Pharmacokinetics of Vibegron (MK-4618) in Adults With Hepatic Insufficiency (MK-4618-013)
Condition: Overactive Bladder
MeSH terms: Hepatic Insufficiency; Liver Failure; Urinary Bladder, Overactive
Intervention: Vibegron
Intervention description: 50 mg tablet, oral
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: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will investigate the pharmacokinetics of a single oral dose of vibegron (MK-4618)
      administered to participants with moderate hepatic insufficiency and healthy participants
      matched for age, gender, and body mass index (BMI). Participants may be enrolled with mild
      hepatic insufficiency.
    

Eligibility criteria:

        Inclusion Criteria

        For both healthy participants and participants with hepatic insufficiency:

          -  Continuous non-smokers who haven't used nicotine-containing products for at least 3
             months prior to study drug administration

          -  Body mass index (BMI) ≤39 kg/m^2

          -  Good health based on medical history, physical examination, vital signs, laboratory
             safety tests, and electrocardiogram (ECG)

          -  Females of childbearing potential must be sexually inactive for 14 days prior to study
             drug administration and throughout study or use acceptable birth control method

          -  Females of non-childbearing potential must have undergone an acceptable sterilization
             procedure at least 6 months prior to Day 1 of study or be postmenopausal with
             amenorrhea for at least 1 year prior to Day 1

          -  Non-vasectomized males must agree to use a condom with spermicide or abstain from
             sexual intercourse during the trial and for 3 months after study drug administration

        For participants with hepatic insufficiency only:

          -  Diagnosis of chronic, stable, hepatic insufficiency

          -  For Part 1 Participants: Child-Pugh scale range from 7 to 9

          -  For Part 2 Participants: Child-Pugh scale range from 5 to 6
Effects of the NO-synthase Inhibitor VAS203 on Renal Function in Healthy Volunteers
Condition: Renal Function Impairment in Healthy Volunteers
Intervention: VAS203; Saline
Intervention description: Infusion of NO-Synthase inhibitor VAS203; Infusion of saline
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Analysis of the effect of the NO-Synthase inhibitor VAS203 (6 hours infusion of 10 mg/kg) on
      renal function and perfusion in 16 healthy subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Informed consent in writing available.

          2. Willing and able to comply with all requirements of the study.

          3. Male, 18 and 45 years (inclusive).

          4. Subject has a body weight between 60 kg and 100 kg, extremes included.

          5. BMI 18 to 27 kg/m2.

          6. Non-smoker

          7. Serum creatinine within reference range (≤1.2 mg/dL) and Cockroft-Gault Clearance > 90
             ml/min

          8. Good general health as judged by the Investigator, as determined by medical history,
             physical examination, vital signs (systolic and diastolic blood pressure and pulse
             rate) and clinical laboratory parameters (clinical chemistry, hematology, and
             urinalysis)

        Exclusion Criteria:

          1. Clinically significant abnormalities in physical examination, vital signs or clinical
             laboratory parameters (according to the Investigator's judgment).

          2. Serum glutamate oxaloacetate transaminase or glutamate-pyruvate transaminase > 2-times
             above the upper limit of normal range.

          3. Subject with Cockcroft-Gault clearance < 90 ml/min.

          4. Clinically significant history of cardiovascular disease or any known present
             cardiovascular disease.

          5. History of clinically significant neurological, gastrointestinal, renal, hepatic,
             psychological, pulmonary, metabolic, endocrine, hematological, or other major
             disorders.

          6. Office blood pressure at screening higher than 160/100 mmHg, or lower than 95/55 mmHg.

          7. Office heart rate at screening after at least 5 minutes outside the range of 50- 99
             beats per minute (inclusive).

          8. Concomitant use of OTC medication within 1 week prior to dosing, except use of
             paracetamol (up to 2 g/day).

          9. Participation in any other clinical study within 30 days prior to inclusion in this -
A Study of How the Body Breaks Down and Eliminates LY2623091
Condition: Healthy Volunteers
Intervention: LY2623091
Intervention description: Administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This type of study is called a radiolabeled study. For this study, LY2623091 (study drug) has
      been specially prepared to contain radiolabeled carbon [^14C]. [^14C] is a naturally
      occurring radioactive form of the element, carbon. This study will increase understanding
      about how the drug appears in the blood, urine, and stool after it is administered to healthy
      participants. Information about any side effects that may occur will also be collected. This
      study will last up to 22 days for each participant, not including screening. Screening is
      required within 28 days prior to enrollment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy males; as determined by physical examination, clinical laboratory
             tests, medical history and electrocardiograms (ECGs).

          -  With a body mass index of 18.5 to 32.0 kilogram per square meter (kg/m^2), inclusive.

        Exclusion Criteria: