bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Galcanezumab in Healthy Participants
Condition: Healthy
Intervention: Galcanezumab; Placebo
Intervention description: Administered SC; Administered SC
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 178.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purposes of this study are:

        -  To evaluate tolerability of the Galcanezumab solution injectable formulation (Part A)

        -  To measure how much of the Galcanezumab lyophilized (freeze dried) injectable
           formulation is absorbed into the blood stream and how long it takes the body to get rid
           of it compared to the Galcanezumab solution injectable formulation after a single
           injection under the skin (subcutaneous [SC]) (Part B).

      Information about any side effects that may occur will also be collected. Each part of the
      study will last about six months. Participants may only enroll in one part.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female healthy participants

          -  Have a body mass index of 19.0 to 35.0 kilograms per meter square (kg/m²), inclusive

        Exclusion Criteria:

        - Currently smoke in excess of 5 cigarettes/day
Bioequivalence of Empagliflozin and Metformin Given as a Fixed Dose Combination Compared to Single Tablets
Condition: Healthy
Intervention: empagliflozin; metformin (Glucophage®); metformin (Glucophage®); empagliflozin; empagliflozin and metformin; empagliflozin and metformin
Intervention description: single tablet empagliflozin; single tablet metformin; single tablet metformin; single tablet empagliflozin; FDC tablet empagliflozin and metformin; FDC tablet empagliflozin and metformin
Intervention MeSH terms: Metformin; Empagliflozin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this trial is to establish bioequivalence of two fixed dose
      combination (FDC) tablets (containing medium dose empagliflozin/500 mg metformin [Test 1] and
      low dose empagliflozin/500 mg metformin [Test 2]) and of the single tablets (medium dose
      empagliflozin tablets + Glucophage® 500 mg tablet [Reference 1] and low dose empagliflozin
      tablet + Glucophage® 500 mg tablet [Reference 2]) when administered together after a high
      fat, high caloric meal.

      The assessment of safety and tolerability will be an additional objective of this trial.
    

Eligibility criteria:

        Inclusion criteria:

          1. Healthy male and female subjects

          2. Subjects must be able to understand and comply with study requirements

          3. Age 18 to 50 years

          4. Body mass index (BMI) 18.5 to 29.9 kg/m2

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions
A Study to Evaluate the Effect of Hepatic Impairment on the Single Dose Pharmacokinetics (PK) of Intravenous TAK-954
Condition: Hepatic Impairment; Healthy Volunteers
MeSH terms: Liver Diseases
Intervention: TAK-954
Intervention description: TAK-954 intravenous infusion.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to evaluate the effect of varying degrees of hepatic function on
      the single dose PK of IV TAK-954.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female participants (non-childbearing potential), with a body mass index
             (BMI) between 18 to 35 kilogram per square meter (kg/m^2) (All participants).

          2. Participants with hepatic impairment who are medically stable as determined by the
             investigator, based on medical history and clinical evaluations including physical
             examinations, clinical laboratory tests, vital sign measurements, and 12-lead ECGs
             performed at the Screening Visit and at check-in on Day -1 (Group 1 to 3).

          3. Healthy participants (Group 4).

        Exclusion Criteria:

        Participants who have:

          1. A history of hepatic carcinoma, hepatorenal syndrome, or presence of a liver mass by
             ultrasound, CT or MRI, or acute liver disease caused by an infection or drug toxicity
             (Group 1 to 3).

          2. Have severe hepatic encephalopathy ([greater than] > Grade II Portal Systemic
             Encephalopathy Score) (Group 1 to 3).

          3. Surgical porto-systemic shunts, including transjugular intrahepatic portosystemic
             shunt (Group 1 to 3).

          4. A history of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers
             less than 1 month prior to trial entry (Group 1 to 3).

          5. Bilirubin levels above 5 times the upper limit of normal (ULN) at screening or Day -1
             for Groups 1 and 2, there is no limit for Group 3.

          6. Severe/advanced ascites and/or pleural effusion which requires emptying and albumin
             supplementation, as judged by the investigator (Group 1 to 3).

          7. Renal creatinine clearance (CLcr) less than or equal to (<=) 50 milliliter per minute
             (mL/min), calculated using the Cockcroft-Gault equation from the serum creatinine
             measurement taken at screening (Group 1 to 3).

          8. Who have a history of clinically significant endocrine, gastrointestinal (GI)
             (including motility disorder and intestinal obstruction), cardiovascular,
             hematological, hepatic, immunological, renal, respiratory, genitourinary, or major
             neurological (including stroke and chronic seizures) abnormalities or diseases will be
             excluded from the trial (Group 4).
A Phase 1, Multiple Intravenous Dose Study to Examine Safety, Tolerability, and PK of Intravenous TD-8954, a 5-HT4 Receptor Agonist, in Healthy Subjects
Condition: Gastrointestinal Motility Disorder
Intervention: TD-8954; Placebo - saline
Intervention description: Intravenous infusion; Intravenous infusion
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a single-center, randomized, double-blind, placebo-controlled study to evaluate the
      safety, tolerability, and pharmacokinetics (PK) of repeated IV doses of TD-8954 in healthy
      adults 18 to 45 years of age and healthy elderly subjects 65 to 85 years old. A healthy
      elderly subject population is included to evaluate the safety, tolerability, and PK of
      TD-8954 IV. Pharmacodynamic effects on bowel movements will also be evaluated. Screening for
      all cohorts will be conducted within 21 days before the first dose.
    

Eligibility criteria:

        Inclusion Criteria:

          1. For Cohorts 1: adult males and females age 18 to 45 years, inclusive; for Cohorts 2
             and 3, adult males and females 65 to 85 years of age, inclusive; for Cohort 4, adult
             males and females 18 to 45 or 65 to 85 years of age, inclusive.

          2. Body mass index (BMI)between 18 to 36 kg/m2, inclusive.

          3. Average frequency of ≥ 3 bowel movements per week.

        Exclusion Criteria:

          1. Persistent symptoms of functional GI disorder (such as irritable bowel syndrome,
             functional constipation, functional dyspepsia, or other symptom-based GI disorders
             unexplained by a pathologically based disorder) during the 6 months prior to
             screening, including a history of major surgery of the GI tract, excluding
             cholecystectomy and appendectomy.

          2. History or presence of clinically significant respiratory, GI, renal, hepatic,
             endocrine, hematological, neurological (including chronic headache, current or prior
             psychiatric disease/condition, stroke), cardiovascular, psychiatric, musculoskeletal,
             genitourinary, immunological, or dermatological disorders. Subjects with mild,
             chronic, stable disease (e.g., controlled hypertension, controlled
             hypercholesterolemia, non insulin-dependent diabetes, osteoarthritis) may be enrolled
             if the condition is well controlled and not anticipated to interfere with the
             objectives of the study.
Phase I Study of MK-0683 in Combination With Bortezomib in Participants With Multiple Myeloma (MK-0683-098)
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Vorinostat; Bortezomib
Intervention description: Vorinostat (MK-0683) three or four 100 mg capsules taken by mouth with food.; Bortezomib (1.0 or 1.3 mg/m^2) intravenous infusion.
Intervention MeSH terms: Bortezomib; Vorinostat
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The primary purpose of this clinical study is to determine the recommended clinical doses of
      vorinostat (MK-0683) and bortezomib administered in combination to participants with relapsed
      and/or refractory multiple myeloma (MM). It was hypothesized that administration of
      vorinostat in combination with bortezomib is sufficiently safe and tolerated well enough to
      permit further study in participants with relapsed and/or refractory MM. Study results are
      based on data collected up to the data cut-off date of 20-March-2011.
    

Eligibility criteria:

        Inclusion Criteria:

          -  is ≥20 years of age.

          -  has an established diagnosis of MM based on the myeloma diagnostic criteria

          -  has received at least 1 but not more than 3 prior anti-myeloma regimens and has
             progressive disease after the most recent treatment regimen

          -  has adequate organ function

        Exclusion Criteria:

          -  has had a prior allogeneic bone marrow transplant or plans to undergo any type of bone
             marrow transplantation during the study

          -  has known hypersensitivity to any components of vorinostat or bortezomib

          -  has active hepatitis B or C, plasma cell leukemia, or is human immunodeficiency virus
             (HIV) positive

          -  has had prior treatment with vorinostat or histone deacetylase (HDAC) inhibitors
Phase 1 Study to Determine the Effects of PBT2 on the Pharmacokinetic Profile of Caffeine
Condition: Healthy Volunteers
Intervention: PBT2
Intervention description: PBT2 250 mg administered
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to determine the pharmacokinetic (PK) profile of a single oral dose of
      caffeine and the effects that PBT2 has on the metabolism of caffeine in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males or females with a BMI between 19 and 30kg/m2

          -  No clinically significant abnormalities

        Exclusion Criteria:

          -  Exposure to medications/drugs that interfere with metabolism of PBT2 including drugs
             that inhibit or induce CYP1A2

          -  Use of caffeine-containing beverages, supplements or alcohol

          -  Significant history of depression or other psychiatric illness

          -  Surgical or medical conditions which could significantly alter drug absorption,
             distribution, metabolism or excretion

          -  Unable to swallow capsules or tablets
Safety, Pharmacokinetic and Pharmacodynamic Study of COR-1, an Anti-ß1 Receptor Antibody Cyclopeptide
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: COR-1; placebo
Intervention description: single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1; intravenous 0.9 % NaCl
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 50.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: anti-beta1 adrenergic receptor; autoantibody; cyclic peptide; heart failure

Summary:

      Primary Trial objectives:

      To evaluate the pharmacokinetics and -dynamics of five strengths of COR-1 (10, 40, 80, 160,
      240 mg) in 50 healthy, male volunteers after single intravenous administration (8 subjects on
      verum per dose level, 10 subjects receiving placebo)

      Secondary objectives:

      To evaluate safety and tolerability by using adverse events (AEs) and vital signs
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, male Caucasians between 18 and 45 years of age, inclusive

          -  Normotensive subjects (systolic BP <140 mmHg and diastolic BP <90 mmHg)

          -  Body mass index (BMI) 19-27, minimal weight 60 kg

          -  Negative results in HIV antibody, HBs antigen (HBsAg) and HCV tests, and negative
             result in anti-ß1-receptor-autoantibody screening

          -  Signed Informed Consent Form

          -  Normal or clinically irrelevant laboratory findings

        Exclusion Criteria:

          -  Autoimmune disorders

          -  Kidney diseases

          -  Liver diseases, liver function impairments
Trial for Studying Pharmacokinetic Effects of Ketoconazole on CG100649
Condition: Healthy
Intervention: CG100649; Ketoconazole
Intervention description: I period: CG 100649 II period: Ketoconalzole + CG100649 at the same time; I period: ketoconazole + CG100649 II period: CG 100649
Intervention MeSH terms: Ketoconazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: Male
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: healthy male volunteers

Summary:

      This is a Phase I, open-labeled, randomization and 2x2 Cross trial to compare the
      pharmacokinetic effects between ketoconazole and CG100649 for healthy male volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 19-55 years old and weight 50kg above with within 20% of ideal body weight

          2. No significant chronic/congenital disease

          3. Normal results for lab test

          4. Ability of informed consent

        Exclusion Criteria:

          1. History or presence of liver, kidney, or nervous system disease, respiratory
             disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric
             or cognitive disorders.

          2. History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or
             disorders of absorption, distribution, metabolism, excretion.

          3. History of known hypersensitivity to drugs including CG100649.

          4. After taking a rest in sitting position for 3 minutes, subjects who have low blood
             pressure (Systolic BP ≤ 90 mmHg or Diastolic BP ≤ 50 mmHg) or high blood pressure
             (Systolic BP ≥ 150 mmHg or Diastolic BP ≥ 100 mmHg).
A Dose Escalation/Expansion Study of LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase
Condition: Tumors Characterized by Genetic Abnormalities of ALK
MeSH terms: Congenital Abnormalities
Intervention: LDK378
Intervention description: LDK378 is a selective and a potent inhibitor of anaplastic lymphoma kinase (ALK) activity, is a capsule and is administered orally.
Intervention MeSH terms: Ceritinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 304.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ALK inhibitor,; NSCLC,; LDK378,; ceritinib,; genetic abnormalities

Summary:

      This study assessed the safety and efficacy of LDK378 in adult patients with genetic
      abnormalities in anaplastic lymphoma kinase (ALK).
    

Eligibility criteria:

        Inclusion Criteria:

          -  ECOG Performance Status of ≤ 2 and life expectancy of ≥ 12 weeks.

          -  Diagnosed with a locally advanced or metastatic malignancy that has progressed despite
             standard therapy, or for which no effective standard therapy exists. Only patients
             with tumors characterized by genetic abnormalities in ALK were enrolled.

          -  For NSCLC, an ALK translocation must be detected by FISH in ≥ 15% of tumor cells.

          -  In patients with diseases other than NSCLC, ALK translocation is not required and
             overexpression of ALK protein may be considered indicative of a genetic abnormality in
             ALK.

          -  Patients with measurable or non-measurable disease as determined by modified RECIST
             version 1.0 in dose-escalation phase, and patients with at least one measurable lesion
             as determined by RECIST 1.0 in expansion phase.

        Exclusion Criteria:

          -  Patients with symptomatic central nervous system (CNS) metastases who were
             neurologically unstable or required increasing doses of steroids to control their CNS
             disease were excluded.

          -  Patients with a prior or current history of a second malignancy, impaired GI function,
             history of pancreatitis or increased amylase or lipase, known diagnosis of HIV, and
             clinically significant cardiac disease were excluded.

          -  Patients treated with chemotherapy or biologic therapy or other investigational agent
             < 2 weeks prior to starting study drug for compounds with a half-life ≤ 3 days, and <
             4 weeks prior to starting study drug for compounds with a prolonged half-life were
             excluded.

          -  Further, patients treated with medications that were known to be strong inhibitors or
             inducers of CYP3A4/5 that could not be discontinued at least a week prior to start of
             treatment with LDK378 and for the duration of the study were also excluded.

        Other protocol-defined inclusion/exclusion criteria may apply
Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: PRO 140
Intervention description: Monoclonal antibody to CCR5
Intervention MeSH terms: Leronlimab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to determine the safety and tolerability of PRO 140, an
      investigational anti-HIV drug, administered via intravenous infusion.

      Study hypothesis: Single intravenous doses of PRO 140 can be safely administered to humans
      and will result in measurable concentrations of the product in serum.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Not more than 20% below or 20% above ideal weight for height and estimated frame size

          -  Good health, with no clinically significant abnormal findings on the physical
             examination, medical history, or laboratory tests

        Exclusion Criteria:

          -  History of clinically significant disease

          -  History of clinically significant allergies, including drug allergy

          -  Participated in another clinical trial within the 3 months prior to study entry

          -  HIV infected

          -  Hepatitis B or C virus infected

          -  Active significant infection

          -  Prior exposure, allergy, or known hypersensitivity to PRO 140
Study to Evaluate the Pharmacokinetics of Velpatasvir in Participants With Normal Renal Function and Severe Renal Impairment
Condition: Hepatitis C Virus
MeSH terms: Hepatitis C
Intervention: Velpatasvir
Intervention description: Velpatasvir 100 mg (2 x 50 mg tablets) administered orally
Intervention MeSH terms: Velpatasvir
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of the study is to evaluate the single-dose pharmacokinetics (PK) of
      velpatasvir (formerly GS-5816) in participants with severe renal impairment using matched
      healthy participants as a control group.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  General good health with stable chronic kidney disease in Severe Renal Impairment
             Group

          -  Screening labs within defined thresholds

          -  Creatinine clearance must be < 30 mL/min for Severe Renal Impairment group, and ≥ 90
             mL/min for Normal Renal Function group

        Key Exclusion Criteria:

          -  Females who are pregnant or nursing, or males who have a pregnant partner

          -  Infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV

          -  History of clinically significant illness (including psychiatric or cardiac) or any
             other medical disorder that may interfere with participant treatment and/or adherence
             to the protocol

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.