bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Investigate the Effect of Rifampicin on the PK of Multiple Doses of Balovaptin In Healthy Volunteers
Condition: Healthy Volunteers
Intervention: Balovaptan; Rifampicin
Intervention description: In Period 1, balovaptan was administered alone as a once daily (qd) dose on Days 1 to 10.
In Period 2, balovaptan was administered as a qd dose on Days 7 to 16.; In Period 2, 600 mg of rifampicin will be administered alone as a qd dose from Day 1 to Day 6, and as a qd dose on Days 7 to 16.
Intervention MeSH terms: Rifampin; Balovaptan
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Single Group 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 single-center, non-randomized, open-label, one-sequence, two-period,
      within-subject study to investigate the effects of multiple doses of rifampicin on the PK and
      safety of multiple doses of balovaptan in healthy subjects. 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.

        Rifampicin-related Exclusion Criteria:

          -  Subjects diagnosed, or suspected of having porphyria, and subjects with first-degree
             relatives diagnosed, or suspected of having porphyria.

          -  Known hypersensitivity to rifampicin
A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using Tirzepatide
Condition: Overweight; Obesity; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Overweight; Diabetes Mellitus, Type 2
Intervention: Tirzepatide; Acetaminophen
Intervention description: Tirzepatide administered SC.; Acetaminophen administered orally.
Intervention MeSH terms: Acetaminophen; Tirzepatide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to learn more about how tirzepatide affects stomach emptying in
      overweight/very overweight participants. Participants include those without diabetes and
      those with type 2 diabetes.

      The study will last about 13 weeks for each participant, including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a body mass index (BMI) between 27 to 45 kilograms per meter squared (kg/m²),
             inclusive at screening

          -  For nondiabetic subjects: as determined by medical history, physical examination, and
             safety assessments at screening

          -  For participants with a confirmed type 2 diabetes diagnosis: The condition must be
             managed either by diet and exercise alone or on a stable dose of metformin for the
             past 3 months

          -  Willing and agreeable to commit to the duration of the study and undergo study
             procedures as instructed by the clinic staff

        Key Exclusion Criteria

          -  Have undergone gastric bypass or bariatric surgery

          -  Have received prescription drugs or over the counter drugs that promote weight loss in
             the past 6 months prior to screening

          -  For participants with a confirmed type 2 diabetes diagnosis: Have experienced more
             than 1 episode of severe low blood sugar that require emergency treatment,
             hospitalization or third parties to administer rescue treatment, in the past 6 months

          -  Have any lifetime history of a suicide attempt

          -  Have other medical conditions or medical history that make participation in the study
             unsafe or which may interfere in the interpretation of the results of the study

          -  Unwilling to comply with smoking and alcohol restrictions during the study
Bioavailability Study of 2 Oral Formulations of ALXN1840
Condition: Healthy
Intervention: ALXN1840
Intervention description: ALXN1840 will be administered orally.
Intervention MeSH terms: Choline
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a 2-period, 2-sequence, crossover study with a parallel group extension.
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioavailability; Healthy

Summary:

      The study will assess the relative bioavailability of 2 different formulations of ALXN1840 in
      healthy participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  No clinically significant history or presence of electrocardiogram findings

          -  Body weight ≥50 to ≤100 kilograms (kg) and body mass index 18 to <32 kg/meter squared
             for all participants

          -  Willing and able to follow protocol-specified contraception requirements

        Exclusion Criteria:

          -  History or presence of clinical and/or laboratory disorders

          -  Abnormal blood pressure, defined as supine blood pressure ≤90/60 millimeters of
             mercury (mmHg) or >140/90 mmHg

          -  Lymphoma, leukemia, or any malignancy within the past 5 years

          -  Alanine aminotransferase, aspartate aminotransferase, or total bilirubin > upper limit
             of normal

          -  Serum copper or serum ceruloplasmin below lower limit of normal

          -  Hemoglobin <130 grams (g)/liter (L) for males and hemoglobin <115 g/L for females

          -  Significant allergies

          -  Smoker
Pharmacokinetics of Voxilaprevir in Adults With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
Condition: HCV Infection
MeSH terms: Hepatitis C
Intervention: Voxilaprevir
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: 33.0
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), safety, and
      tolerability of a single dose of voxilaprevir (formerly GS-9857) in participants with normal
      hepatic function, moderate hepatic impairment and severe hepatic impairment. Participants in
      the healthy control group will be matched to participants with impaired hepatic function by
      gender, age (± 10 years), and body mass index (± 15%).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  All individuals:

               -  Screening laboratory values within defined thresholds for group

               -  Use of two effective contraception methods if female of childbearing potential or
                  sexually active male

          -  For individuals with moderate hepatic impairment:

               -  Diagnosis of chronic (> 6 months) hepatic impairment

               -  Score on the Child-Pugh-Turcotte (CPT) scale of 7-9 at screening (Child Pugh
                  Class B).

          -  For individuals with severe hepatic impairment:

               -  Diagnosis of chronic (> 6 months) hepatic impairment

               -  Score on the CPT scale of 10-15 at screening (Child Pugh Class C)

          -  For individuals with normal hepatic function:

               -  Hepatitis C Virus (HCV) antibody and hepatitis B surface antigen negative

        Key Exclusion Criteria:

          -  All individuals:

               -  Pregnant or nursing female or male with pregnant female partner

               -  HIV infection

               -  History of clinically significant illness or any other medical disorder that may
                  interfere with the individual's treatment, assessment or compliance with the
                  protocol

          -  For individuals with moderate or severe hepatic impairment:

               -  Active HCV infection

               -  Current hepatic encephalopathy

               -  Variceal bleeding in the last 6 months unless banded

               -  Prior placement of a portosystemic shunt

               -  History of hepatorenal or hepatopulmonary syndrome

               -  Spontaneous bacterial peritonitis currently or within the last 6 months

               -  Hospitalization within the last 2 months related to cirrhosis

               -  Confirmed hypotension

               -  Suspicion of hepatocellular carcinoma

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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
Mass-balance Study of [14C]-APD421 in Healthy Volunteers
Condition: Post-operative Nausea and Vomiting
MeSH terms: Vomiting; Postoperative Nausea and Vomiting
Intervention: 14C-APD421
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
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:

      Open-label, non-randomised, single dose study in 6 healthy male subjects to assess the mass
      balance recovery, metabolite profile, metabolite identification and pharmacokinetics of
      14C-labelled APD421
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males

          -  Age 18 to 65 years of age at time of signing informed consent

          -  Body mass index (BMI) of 18 to 30 kg/m2 or, if outside the range, considered not
             clinically significant by the investigator

          -  Must be willing and able to communicate and participate in the whole study

          -  Must provide written informed consent

          -  Must agree to use an adequate method of contraception (as defined in Section 8.4)

          -  Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per
             day)

        Exclusion Criteria:

          -  Prior participation in another study with a radiation burden of > 0.1 mSv and ≤ 1 mSv
             in the period of 1 year prior to screening; a radiation burden of > 1 mSv and ≤ 2 mSv
             in the period of 2 years prior to screening; a radiation burden of > 2 mSv and ≤ 3 mSv
             in the period of 3 years prior to screening, etc (add 1 year per 1 mSv)
Pharmacokinetic, Safety, Tolerability, and Immunogenicity Study of SB8 in Healthy Male Subjects
Condition: Healthy
Intervention: SB8; EU sourced Avastin®; US Sourced Avastin®
Intervention description: SB8, proposed bevacizumab biosimilar; EU sourced Avastin® (bevacizumab, Roche Registration Ltd.); US Sourced Avastin® (bevacizumab, Roche Registration Ltd.)
Intervention MeSH terms: Bevacizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 119.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of
      Bevacizumab
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male subjects

          -  Have body weight between 65.0-90.0 kg (inclusive) and body mass index between
             20.0-29.9 kg/m2 (inclusive)

        Exclusion Criteria:

          -  Have a history of hypersensitivity or allergic reactions to bevacizumab or to any of
             the excipients

          -  Have a history of and/or current clinically significant gastrointestinal, renal,
             hepatic, cardiovascular, haematological, pulmonary, neurologic, metabolic,
             psychiatric, or allergic disease excluding mild asymptomatic seasonal allergies

          -  Have a history of arterial thromboembolic events including cerebrovascular accidents,
             transient ischaemic attacks, and myocardial infarction

          -  Have a history of and/or current cardiac disease

          -  Have previously been exposed to vascular endothelial growth factor (VEGF) antibody,
             any other antibody, or protein targeting the VEGF receptor

          -  Have a history of cancer including lymphoma, leukaemia, and skin cancer.

          -  Have received live vaccine(s) within 30 days prior to Screening visit or who will
             require a vaccine(s) between Screening and the end of study visit

          -  Have taken medication with a half-life of > 24 hours within 30 days or 10 half-lives
             of the medication prior to the IP administration
This Study Tests Whether Taking the Medicines Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills. The Study is Done in Healthy Men and Women and Measures the Amount of Each Medicine in the Blood
Condition: Healthy
Intervention: Empagliflozin/linagliptin/metformin HCl; Empagliflozin; Linagliptin; Metformin HCl
Intervention description: Once daily; Once daily; Once daily; Once daily
Intervention MeSH terms: Metformin; Empagliflozin; Linagliptin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To establish the bioequivalence of one fixed dose combination (FDC) tablet of
      empagliflozin/linagliptin/metformin extended release (XR) versus the free combination of
      empagliflozin tablet, linagliptin tablet, and metformin XR tablets administered as a single
      dose under fed conditions
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or female subjects according to the assessment of the investigator, based
             on a complete medical history including a physical examination, vital signs (Blood
             Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical
             laboratory tests

          -  Age of 18 to 55 years (incl.)

          -  BMI of 18.5 to 29.9 kg/m2 (incl.)

          -  Signed and dated written informed consent prior to admission to the study in
             accordance with Good Clinical Practice (GCP) and local legislation

          -  Female subjects of childbearing potential willing to use adequate contraception.

          -  Further inclusion criteria apply

        Exclusion Criteria:

          -  Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate
             (PR), or Electrocardiogram (ECG)) is deviating from normal and judged as clinically
             relevant by the investigator

          -  Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg,
             diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the
             range of 45 to 90 beats per minute (BPM)

          -  Any laboratory value outside the reference range that the investigator considers to be
             of clinical relevance

          -  Any evidence of a concomitant disease judged as clinically relevant by the
             investigator

          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological, or hormonal disorders

          -  Diseases of the central nervous system (including but not limited to any kind of
             seizures or stroke), and other relevant neurological or psychiatric disorders

          -  Further exclusion criteria apply
Autologous Adult Stem Cells to Patients With Type 1 Diabetes and a Successful Renal Transplant
Condition: Type 1 Diabetes; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Autologous CD34+ stem cells
Intervention description: Up to 5 x 10 log 8 of autologous stem cells on a single occasion
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Autologous stem cells
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: diabetes type I; diabetes type 2; renal transplant; stem cells; successful renal transplant

Summary:

      This is a phase I study to assess the safety and tolerability of infusing expanded stem cells
      into the pancreas of patients with type I diabetes and a successful renal transplant. The
      stem cells used in this study occur naturally in the body and are collected from each
      recipient by a procedure called leukapheresis. The cells are then expanded and differentiated
      into insulin-like cells in a sterile suite before being injected into the body or tail of the
      pancreas of the recipient.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients aged from 16 to 65 years of age

          -  Patient with Type I or Type 2 diabetes mellitus plus:

          -  Successful previous kidney transplant.

          -  Good kidney allograft function /no episodes of rejection for at least one year
             post-transplant

          -  Not taking steroids as part of standard immuno-suppression

          -  Has a WHO performance score of less than 2

          -  Has a life expectancy of at least 3 months

          -  Ability to give written consent

          -  Women of childbearing potential may be included, but must use a reliable and
             appropriate contraceptive method

        Exclusion Criteria:

          -  Patients below the age of 16 or above the age of 65 years

          -  Patients with chronic pancreatitis and poor exocrine pancreatic function

          -  Pregnant or lactating women

          -  Patients with recent recurrent GI bleeding or spontaneous bacterial peritonitis

          -  Patients with evidence of HIV or other life threatening infection

          -  Patients unable to give written consent

          -  Patients with a history of hypersensitivity to G-CSF

          -  Patients who have been included in any other clinical trial within the previous month