bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Moderate CYP3A Inducer Rifabutin on the Pharmacokinetics of Zanubrutinib in Healthy Males
Condition: Healthy; Male
Intervention: Zanubrutinib; Rifabutin
Intervention description: Single oral dose of 320 mg; Oral dose of 300 mg once daily
Intervention MeSH terms: Rifabutin; Zanubrutinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Phase 1; Healthy volunteers; Pharmacokinetics

Summary:

      The primary objective of this study was to determine the effect of the moderate cytochrome
      P450 3A (CYP3A) inducer rifabutin on the pharmacokinetics (PK) of zanubrutinib in healthy
      males.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Males of any race, between 18 and 65 years of age, inclusive.

          2. Male participants in good health as determined by past medical history, physical
             examination, vital signs, ECG and laboratory tests at screening

          3. Must have a body mass index (BMI) between 18 and 32 kg/m^2

        Key Exclusion Criteria:

          1. Participants with a clinically relevant history or presence of any clinically
             significant disease

          2. History of stomach or intestinal surgery or resection that would potentially alter
             absorption and/or excretion of orally administered drugs (uncomplicated appendectomy,
             cholecystectomy, and hernia repair will be allowed)

          3. History of drug or alcohol abuse within 1 year prior to check-in

          4. Use or intended use of any nonprescription medications/products including vitamins,
             minerals, herbal/plant-derived preparations within 7 days prior to check-in

          5. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result and/or a
             positive human immunodeficiency virus (HIV) at screening

          6. Use of tobacco- or nicotine-containing products within 3 months prior to check-in

          7. Use or intended use of any prescription medications/products within 14 days prior to
             check-in

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study to Investigate the Bioequivalence of Two Different Forms of Entrectinib (Forms A and C) Under Fasted Conditions in Healthy Subjects
Condition: Healthy Volunteers
Intervention: Entrectinib Form A; Entrectinib Form C
Intervention description: Participants will receive a single oral dose of entrectinib form A under fasted conditions.; Participants will receive a single oral dose of entrectinib form C under fasted conditions.
Intervention MeSH terms: Entrectinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study aims to demonstrate similarities between two different forms of entrectinib (A and
      C) when administered under fasted conditions in healthy subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy in the opinion of the investigator. Healthy is defined by the absence of
             evidence of any active disease or clinically significant medical condition based on a
             detailed medical history and examination

          -  Negative test results for Hepatitis B, Hepatitis C, and Human Immunodeficiency Virus
             (HIV)

          -  Females must not be pregnant or breastfeeding, and females of childbearing potential
             will agree to use highly-effective contraception. Females of childbearing potential
             must also agree to refrain from donating eggs during the treatment period and for 6
             weeks after the final dose of study drug

          -  Males must agree to use contraception and to refrain from sperm donation from check-in
             (Day -1 of Period 1) to 90 days after the final dose of study drug

        Exclusion Criteria:

          -  History of gastrointestinal surgery or other gastrointestinal disorder that might
             affect absorption of medicines from the gastrointestinal tract

          -  Presence of a clinically significant disease, illness, medical condition or disorder,
             or any other medical history determined by the investigator to be clinically
             significant and relevant. Ongoing chronic disorders which are not considered
             clinically significant are permissible providing they are stable

          -  Clinically significant change in health status, as judged by the investigator, or any
             major illness within the 4 weeks before screening, or clinically significant acute
             infection or febrile illness within the 14 days before screening

          -  Participation in any other clinical study involving an investigational medicinal
             product (IMP) or device within 30 days or 5 half-lives (if known), whichever is
             longer, before screening
Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic Antibiotics
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Intervention: Ceftobiprole medocaril
Intervention description: Ceftobiprole medocaril was administered as a single intravenous infusion, with a bodyweight-adjusted volume, at a constant rate over 4 hours. The ceftobiprole dose was 7.5 mg/kg, which corresponds to 10.0 mg ceftobiprole medocaril.
Intervention MeSH terms: Ceftobiprole; Ceftobiprole medocaril; Cephalosporins
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Maximum age: 3 Months
Healthy volunteers: No

Summary:

      This study characterized the pharmacokinetics and safety of a single dose of ceftobiprole in
      neonates and infants aged ≤ 3 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Neonates and infants ≤3 months, with gestational age ≥28 weeks

          -  Documented or presumed (or at risk of) bacterial infections, and currently receiving
             antibiotic treatment

          -  Expected to survive beyond the first 7 days after enrollment

          -  Sufficient vascular access to receive study drug, and to allow blood sampling at a
             site separate from the study drug infusion site

          -  Parent's / legally acceptable representative's informed consent to participate in the
             study

        Exclusion Criteria:

          -  Major birth defect or malformation syndrome

          -  Proven presence of an immunodeficiency

          -  HIV or other congenital viral or fungal infection

          -  Significant laboratory abnormalities including: hematocrit <20%; absolute neutrophil
             count <0.5x10⁹/L; platelet count < 50x10⁹/L; alanine aminotransferase or aspartate
             aminotransferase >3 times the age-specific upper limit of normal

          -  Impaired renal function or known significant renal disease

          -  Any condition which would make the subject or caregiver, in the opinion of the
             investigator, unsuitable for the study
Flortaucipir 18F PET Imaging in BIOCARD Study
Condition: Cognitive Decline
MeSH terms: Cognitive Dysfunction
Intervention: Flortaucipir F18; Brain PET scan
Intervention description: 370 megabecquerel (MBq)(10 millicurie [mCi]) single dose; positron emission tomography (PET) scan of the brain
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to assess the imaging characteristics of Flortaucipir (18F-AV-1451) in
      subjects who participated in the Biomarkers of Cognitive Decline Among Normal Individuals
      (BIOCARD) study at Johns Hopkins University.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females that have provided consent and are currently enrolled in BIOCARD
             study

          -  Ability to tolerate PET scan procedures

          -  Ability to provide informed consent for study procedures

        Exclusion Criteria:

          -  Has condition(s) that could augment risk to participant or compromise ability to
             tolerate experimental procedures or interfere with analysis of the study data as
             determined by the investigator

          -  Has a history of risk factors for Torsades de Pointes or taking medications known to
             cause QT prolongation.

          -  Has electrocardiogram acquired prior to initial flortaucipir scan that clinically
             contradicts subject's participation in the study as determined by the investigator.
             Bazett's corrected QT (QTcB) interval must be assessed and not exceed accepted values
             (458 msec in males, 474 msec in females).

          -  Females of childbearing potential who are not surgically sterile, not refraining from
             sexual activity, or not using reliable contraceptive methods.

          -  Has hypersensitivity to flortaucipir

          -  Has a currently clinically significant infectious disease, endocrine/metabolic
             disease, pulmonary/renal/hepatic impairment, or cancer that could impact study
             participation or scan results in the opinion of the investigator.

          -  Has a non-study related radiopharmaceutical imaging/treatment procedure within seven
             days prior to flortaucipir imaging visit.

          -  Is unsuitable for a study of this type in the opinion of the investigator.
Study of TRC105 + Paclitaxel/Carboplatin and Bevacizumab in Patients With NSCLC
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: TRC105
Intervention description: Dose-finding study of TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a single center, open-label, nonrandomized, phase 1b, dose-finding study of TRC105 in
      combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive
      patients with stage IV non-squamous NSCLC.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Stage 4 Non-Squamous Cell Lung Cancer that has not been treated previously with
             systemic chemotherapy or bevacizumab, but may have received prior targeted treatment
             (e.g., alk1 inhibitor)

          -  ECOG performance status ≤ 1

          -  Measurable disease by RECIST

        Key Exclusion Criteria:

          -  Non-small cell lung cancer of squamous histology

          -  Current treatment on another therapeutic clinical trial

          -  Patients who have received wide field radiotherapy ≤ 28 days (defined as > 50% of
             volume of pelvic bones or equivalent) or limited field radiation for palliation < 14
             days prior to study registration or those patients who have not recovered adequately
             from side effects of such therapy

          -  Active bleeding or pathologic condition that carries a high risk of bleeding (e.g.
             hereditary hemorrhagic telangiectasia). Patients who have been uneventfully
             anti-coagulated with low molecular weight heparin are eligible.
A Family-based, Resilience-focused Intervention for War-affected Communities in North-eastern Democratic Republic of Congo
Condition: Psychological Distress
Intervention: Family-Focused, Community-Based, Resilience-Targetting Psychosocial Intervention
Intervention description: A 12-module manualised intervention focusing on reducing psychological distress, improving family and community functioning and boosting daily functioning of adolescents through the use of Mobile Cinema Screenings and task-based, participatory, group-sessions
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 159.0
Sex: All
Minimum age: 7 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: community-based; war-affected; psychosocial support; family-focused; psychological distress; adolescents; Democratic Republic of Congo; family functioning; community functioning; daily functioning

Summary:

      The main research question of the study is whether a family-based, life-skills focused
      psychosocial intervention is effective in reducing psychological distress and stigma and
      improving inter-personal relations and functioning among war-affected children in the
      Democratic Republic of Congo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  War-affected

          -  eastern Democratic Republic of Congo

          -  Formerly abducted child or vulnerable child

        Exclusion Criteria:

          -  severe/violent behavioural problems

          -  severe learning difficulties
Study to Evaluate the Pharmacokinetics of Filgotinib in Participants With Impaired Hepatic Function
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Filgotinib
Intervention description: 100 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

Summary:

      The primary objective of this study is to evaluate the pharmacokinetics (PK) of filgotinib
      and its metabolite, GS-829845, in participants with varying degrees of impaired hepatic
      function relative to matched, healthy controls.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Eligible individuals will be male and nonpregnant, nonlactating females, aged 18 to 70
             years (inclusive), body mass index (BMI) between 18 and 36 kg/m^2 (inclusive), with
             either impaired hepatic function or normal hepatic function.

          -  Individuals will be current nonsmokers (no use of tobacco, nicotine-containing, or
             tetrahydrocannabinol [THC]-containing products within the last 14 days).

          -  Individuals with hepatic impairment will be categorized by the Child-Pugh-Turcotte
             (CPT) classification system indicating hepatic impairment as follows:

               -  Class A (mild): CPT score 5-6

               -  Class B (moderate): CPT score 7-9

               -  Class C (severe): CPT score 10-15

          -  Hepatic impairment must have been stable during the 3 months (90 days) prior to study
             drug. Each individual in the control group will be matched to a individual with
             impaired hepatic function by age (± 10 years), gender, and body mass index (± 15%).

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Open Label, Adaptive, Parallel Group PET Study Using RO7017773 And [11C] RO15-4513
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Intervention: RO7017773; [11C] Ro15-4513
Intervention description: RO7017773 will be administered orally. The doses to be tested will be determined by review of PET scan, PK, and safety results from the previous dose level.; At the start of each PET scan, participants will receive an intravenous dose of the radiolabeled tracer [11C]Ro15-4513.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 23 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a single dose (SD), non-randomized, open-label, adaptive, parallel group study with
      the purpose of investigating the occupancy of alpha5-containing GABAA receptors by RO7017773
      in healthy participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy (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 chemisty, serology, and urinalysis), as judged by the
             Investigator.

          -  Males and women of non-childbearing potential (WONCBP)

        Exclusion Criteria:

          -  History of convulsions (other than benign febrile convulsions of childhood) including
             epilepsy, or personal history of significant cerebral trauma or CNS infections

          -  Clinically significant abnormal finding from the MRI performed after the initial
             screening examination

          -  Abnormal blood pressure, i.e, systolic blood pressure (SBP) greater than 140 or less
             than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm
             Hg

          -  Abnormal pulse rate, resting pulse rate greater than 100 or less than 40 bpm

          -  History or presence of clinically significant ECG abnormalities before study drug
             administration or cardiovascular disease

          -  Show evidence of human immunodeficiency virus (HIV) infection and/or positive human
             HIV antibodies

          -  Positive result on hepatitis B (HBV) or hepatitis C (HCV), presence of hepatitis B
             surface antigen (HBsAg) or positive hepatitis C antibody test result at screening or
             within 3 months prior to starting study treatment
Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite
Condition: Hepatic Impairment; Hepatic Insufficiency; Healthy Subjects
MeSH terms: Liver Diseases; Hepatic Insufficiency; Liver Failure
Intervention: acalabrutinib
Intervention description: A 50-mg single oral dose of acalabrutinib will be administered.
Intervention MeSH terms: Acalabrutinib
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: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatic; Acalabrutinib

Summary:

      This study is investigate the influence of severe hepatic impairment on the pharmacokinetics
      of acalabrutinib and its metabolite.
    

Eligibility criteria:

        Inclusion Criteria

          -  Women must be of non childbearing status

          -  Understands the study procedures in the ICF and be willing and able to comply with the
             protocol.

          -  Willingness and ability to swallow study drug capsule.

          -  Adult men or women, 18 to 75 years of age

        Hepatic-Impaired Subjects Only:

          -  Subject has a diagnosis of chronic, stable HI.

          -  Subject's score on the Child-Pugh scale must range from 10 to 15 at screening.

        Exclusion Criteria

          -  History or presence of clinically significant or unstable medical or psychiatric
             condition or disease in the opinion of the PI.

          -  Dosed in another clinical trial within 28 days before dosing of study drug and
             throughout the current study.

          -  History or presence of drug abuse within 2 years before screening.
A Study of Lasmiditan in Healthy Japanese and Caucasian Participants
Condition: Healthy
Intervention: Lasmiditan; Placebo
Intervention description: Administered orally.; Administered orally.
Intervention MeSH terms: Lasmiditan
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 27.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to evaluate the safety and tolerability of lasmiditan in
      healthy Japanese and Caucasian participants. The study will also investigate how much
      lasmiditan gets into the bloodstream and how long it takes the body to get rid of lasmiditan
      when given to Japanese and Caucasians. The study will last up to 47 days for each
      participant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy Japanese (first generation) or Caucasian males or females, as
             determined by medical history and physical examination

          -  Have a body mass index of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive

        Exclusion Criteria:

          -  Have known allergies to lasmiditan, related compounds or any components of the
             formulation of lasmiditan

          -  Have previously received the investigational product in this study, withdrawn from
             this study, or received lasmiditan in any other study investigating lasmiditan

          -  Have an abnormal supine blood pressure at screening.

          -  Have a history of syncope, presyncope, uncontrolled vertigo, postural dizziness, or a
             risk of falls, as judged to be clinically significant by the investigator, or have
             orthostatic decreases in supine blood pressure of >20 millimeters of mercury (mmHg),
             or have orthostatic decreases in diastolic blood pressure of >10 mmHg at screening.

          -  Are women who are pregnant, lactating, or have a positive pregnancy test at screening
             or admission to the clinical research unit (CRU)

          -  Have donated blood of more than 500 milliliters (mL) within 1 month prior to screening