bioihbjkbjnl/mcl2 huggingface dataset:
A Comparative Bioavailability and Pharmacokinetic Study of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets in Healthy Adults.
Condition: Healthy
Intervention: Treatment A; Treatment B; Treatment C
Intervention description: TNX-102 2.4 mg - 1 gelcap once under fasting conditions.; Cyclobenzaprine 5 mg, 1 tablet once under fasting conditions; TNX-102 2.4 mg, 1 gelcap once given under fed conditions.
Intervention MeSH terms: Amitriptyline; Cyclobenzaprine
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:

      The trial is designed to assess the safety and tolerability of TNX-102 2.4 mg and to compare
      the bio-availability of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed
      conditions.
    

Eligibility criteria:

        Inclusion Criteria: Healthy adults

          -  Male or female

          -  Non-smoker

          -  18-55 years old

          -  BMI > 18.5 and < 30.0

          -  With medically acceptable form of contraception (female only).

        Exclusion Criteria:

          -  Any clinically significant abnormality or vital sign abnormalities

          -  Any abnormal laboratory test

          -  History of alcohol or drug abuse or dependence within 1 year and/or positive drug,
             cotinine, or alcohol tests

          -  Use of any drug (within 30 days), supplement, or food (within 14 days) known to induce
             or inhibit hepatic drug metabolism prior to study medication

          -  Positive pregnancy test, breastfeeding or lactating

          -  Use of medication other than hormonal contraceptives or topical products, including
             OTC, natural health products, MAO inhibitors

          -  Participation in an investigational study within 30 days prior to dosing

          -  Donation of plasma (within 7 days), or donation or loss of blood of 50-499 mL (within
             30 days), or of > 499 mL (within 56 days) prior to dosing.
A Phase 1 Study of MP-424, Peginterferon Alfa 2b, and Ribavirin in Hepatitis C
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: MP-424(H), PEG-IFN-a-2b, RBV; MP-424 (L), PEG-IFN-a-2b, RBV
Intervention description: MP-424 (three tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks; MP-424 (two tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks
Intervention MeSH terms: Interferon-alpha; Interferon alpha-2; Interferon-alfa-1b; Peginterferon alfa-2b
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Chronic Hepatitis C; Protease Inhibitor; Telaprevir

Summary:

      The purpose of this study is to assess the safety, pharmacokinetics, HCV RNA kinetics, and
      other viral characteristics after administration of two arms of MP-424 in combination with
      Peginterferon Alfa 2b (PEG-IFN-a-2b) and Ribavirin (RBV) to patients with chronic hepatitis
      C.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed with genotype 1b chronic hepatitis C

        Exclusion Criteria:

          -  Patients diagnosed with decompensated cirrhosis

          -  Patients diagnosed with positive HBs antigen in the test
Augmenting Flortaucipir Dosimetry Estimates
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Flortaucipir F18
Intervention description: No flortaucipir administered in this study. Subjects received flortaucipir in an Avid-sponsored study.
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will obtain data from urine in subjects administered flortaucipir in an
      Avid-sponsored study to augment the calculation of radiation dosimetry estimates.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who passed screening in an Avid-sponsored study in which flortaucipir will be
             administered

        Exclusion Criteria:

          -  Subjects who have withdrawn informed consent

          -  Investigator or sponsor believes it is in the best interest of the subject to be
             removed from the trials
Relative Bioavailability of a Single Dose of Nintedanib Given Alone and in Combination With Multiple Doses of Rifampicin
Condition: Healthy
Intervention: Nintedanib; Rifampicin; Nintedanib
Intervention description: single dose administration; single dose once daily for 7 days; single dose administration
Intervention MeSH terms: Rifampin; Nintedanib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To investigate the effect of the P-gp inducer rifampicin on the pharmacokinetic parameters of
      nintedanib
    

Eligibility criteria:

        Inclusion criteria:

        1. Healthy male subjects

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions
Study Evaluating CMC-544 In B-Cell Non-Hodgkin's Lymphoma
Condition: Lymphoma, B-Cell
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
Intervention: Inotuzumab ozogamicin [CMC-544]
Intervention description: CMC-544, IV, dose escalation trial
Intervention MeSH terms: Inotuzumab Ozogamicin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: B-Cell; Non-Hodgkin's; Lymphoma

Summary:

      To determine the Maximum Tolerated Dose (MTD), the tolerability, and the initial safety
      profile of CMC-544 in subjects with B-cell Non-Hodgkin's Lymphoma (NHL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have been previously diagnosed with CD22-positive, B-cell NHL, according
             to WHO classification, which has progressed after at least 2 prior therapies of
             probable clinical benefit

          -  At the expanded cohort, part 2 of the study, subjects must have one of the following:

          -  Follicular lymphoma previously treated with at least one dose of rituximab, but have
             not received radioimmunotherapy

          -  Diffuse large B-cell lymphoma

          -  Age 18 years or older

        Exclusion Criteria:

          -  Candidate for potentially curative therapies in the opinion of the investigator

          -  Chronic lymphocytic leukemia

          -  Burkitt's lymphoma, primary effusion lymphoma, and precursor B-cell lymphoblastic
             lymphoma
Pharmacokinetics and Pharmacodynamics of MK-8245 in Participants With Type 2 Diabetes (MK-8245-012)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: MK-8245; Comparator: placebo
Intervention description: MK-8245 50 mg twice daily for 28 days; matching placebo to MK-8245 twice daily for 28 days
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will assess the safety, tolerability, pharmacokinetics, and glucose lowering
      activity of MK-8245 in participants with type 2 diabetes. The primary hypothesis of the study
      is that after 4 weeks of treatment, MK-8245 produces a greater reduction in 24 hour weighted
      mean glucose (WMG) from baseline than placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a diagnosis of type 2 diabetes and is being treated with diet and exercise
             alone, a single oral anti-hyperglycemic agent or a combination of two oral
             anti-hyperglycemic agents

          -  Subject is willing to follow a weight-maintaining diet and exercise program during the
             study

          -  Subject is a nonsmoker or is willing to limit smoking to 10 cigarettes per day while
             in the clinical research unit

        Exclusion Criteria:

          -  Subject has a history of stroke, chronic seizures, or major neurological disorder

          -  Subject has a history of cancer, except certain skin and cervical cancers or cancer
             that was successfully treated 10 or more years prior to screening

          -  Subject has a history of type 1 diabetes

          -  Subject has used contact lenses within the last 6 months

          -  Subject has used any lipid-lowering therapy in the last 3 months, except statins,
             Zetia, or Vytorin

          -  Subject has more than 3 alcoholic beverages per day

          -  Subject has more than 6 servings of caffeine a day

          -  Subject has participated in a previous MK8245 study
Pharmacokinetics and Safety of BI 201335 in Patients With Mild to Severe Renal Impairment
Condition: Hepatitis C
MeSH terms: Hepatitis C
Intervention: BI 201335; BI 201335
Intervention description: Relevant treatment dose capsule (A) for oral administration; Relevant treatment dose capsule (B) for oral administration
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main objective of this study is to investigate the influence of mild, moderate and severe
      renal impairment on the pharmacokinetics and safety of BI 201335 in comparison to a control
      group with normal renal function after single dose of BI 201335.
    

Eligibility criteria:

        Inclusion criteria:

        Male and female healthy subjects with normal renal function and subjects with impaired
        renal function in relatively good health

        Exclusion criteria:

        Any relevant deviation from healthy conditions for healthy volunteers or significant
        diseases other than renal impairment for the renal impaired subjects
A Study of Carbon-14-Labeled LY2835219 ([^14C]-LY2835219) in Healthy Participants
Condition: Healthy Volunteers
Intervention: [^14C]-LY2835219
Intervention description: Administered as oral solution
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
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, LY2835219 (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 help understand how the
      drug appears in the blood, urine, and stool after it is administered.

      In addition, this study will also evaluate the safety and tolerability of a single dose of
      LY2835219 when given to healthy participants. Information about any side effects that may
      occur will also be collected.

      This study will last about 3 weeks for each participant, not including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy male or female participants as determined by medical history and
             physical examination

          -  Male participants will be sterile

          -  Female participants will be surgically sterile or postmenopausal

          -  Have a body mass index (BMI) of 18 to 29 kilograms per square meter (kg/m^2)

          -  Have venous access sufficient to allow for blood sampling

        Exclusion Criteria:

          -  Have a history or presence of cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine, hematological, or neurological disorders capable of
             significantly altering the absorption, metabolism, or elimination of drugs; of
             constituting a risk when taking the study medication; or of interfering with the
             interpretation of data

          -  Gastrointestinal disorders causing clinically significant symptoms such as nausea,
             vomiting, and diarrhea, or malabsorption syndromes
A Study of LY3084077 in Healthy Participants
Condition: Healthy Volunteers
Intervention: Placebo; LY3084077
Intervention description: Given as a SC injection.; Given as a SC injection.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 43.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to evaluate the safety and tolerability of the study drug
      known as LY3084077 in healthy participants. The study will also investigate how much of the
      study drug gets into the blood stream and how long it takes the body to get rid of it.
      Information about any side effects that may occur will also be collected. The study is
      expected to last approximately 8 weeks for each participant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have normal blood pressure

          -  Must be a healthy male or female who cannot become pregnant

          -  Have a body mass index (BMI) of 18.5 to 40.0 kg/m^2, inclusive, at screening

        Exclusion Criteria:

          -  Have known allergies to fibroblast growth factor-21 (FGF21) analogues, glucagon-like
             peptide-1 (GLP1), GLP1-analogues or other related compounds

          -  Have previous exposure to FGF21 analogues or GLP1 analogues

          -  Have received live vaccine(s) within 1 month of screening, or intend to during the
             study

          -  Have previously completed or withdrawn from this study

          -  Have or used to have health problems or laboratory test results or electrocardiogram
             (ECG) readings that in the opinion of the doctor, could make it unsafe to participate,
             or interfere with understanding the results of the study

          -  Have received treatment with biologic agents (such as monoclonal antibodies) within 3
             months or 5 half-lives (whichever is longer) prior to dosing

          -  Have problems with the immune system, due to a disease or treatment

          -  Have a personal or family history of medullary thyroid carcinoma (MTC) or have
             multiple endocrine neoplasia syndrome type 2

          -  Have a history of pancreatitis
Investigation of Food Effect and Gastric ph Increase on the Bioavailability of Faldapravir
Condition: Healthy
Intervention: faldaprevir; faldaprevir; omeprazole; faldaprevir
Intervention description: medium dose of faldaprevir; medium dose of faldaprevir; medium dose of omeprazole; medium dose of faldaprevir
Intervention MeSH terms: Omeprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this trial is to investigate the effect of food and of gastric pH
      increase on the relative bioavailability of faldaprevir.
    

Eligibility criteria:

        Inclusion criteria:

        1. Healthy male and female subjects

        Exclusion criteria:

        1. Any relevant deviation from healthy condition
Relative Bioavailability of 2 Fixed Dose Combinations of Linagliptin/Metformin Compared With Single Tablets
Condition: Healthy
Intervention: 2x500 mg Metformin (Glumetza); 5 mg Linagliptin/1000 mg Metformin FDC; 5 mg Linagliptin (Tradjenta); 5 mg Linagliptin (Tradjenta); 3x500 mg Metformin (Glumetza); 5 mg Linagliptin (Tradjenta); 2 x 500 mg Metformin (Glumetza); 5 mg Linagliptin/1000mg Metformin FDC; 2 x 2.5 mg Linagliptin/750 mg Metformin FDC
Intervention description: 2 tablets; FDC tablet; 1 tablet; 1 tablet; 3 tablets; 1 tablet; 2 tablets; FDC Tablet; 2 FDC tablets
Intervention MeSH terms: Metformin; Linagliptin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the trial is to demonstrate the relative bioavailability of 2 newly developed
      fixed dose combination (FDC) tablets containing linagliptin & metformin and the single
      tablets of linagliptin and metformin when administered singularly.
    

Eligibility criteria:

        Inclusion criteria:

          1. Healthy males or females

          2. Age 18 -50 years (incl)

          3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)

          4. Subjects must be able to understand and comply with study requirements

        Exclusion criteria:

        Any deviation from healthy condition
Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study
Condition: Cocaine Dependence; Cocaine Addiction; Cocaine Abuse; Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Intervention: Clavulanic acid; Intravenous cocaine; Placebo
Intervention description: Clavulanic acid will be administered orally in 250mg capsules; 20/40mg Cocaine will be administered by IV; Placebo will be administered orally in capsules identical to CLAV and be filled with crystalline microcellulose
Intervention MeSH terms: Clavulanic Acids; Clavulanic Acid; Cocaine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Cocaine; Clavulanic Acid

Summary:

      The main purpose of this study is to determine if it is safe to use the study drug,
      clavulanic acid, in combination with cocaine. In this study, subjects will receive
      intravenous (i.v.) cocaine and the study drug, clavulanic acid. The safety of clavulanic acid
      is being studied so future studies can be done to find out if this drug is helpful in
      treating cocaine dependence. Currently, there is no available medication treatment for
      cocaine dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet Diagnostic and Statistical Manual of Mental Disorders Fifth Edition criteria for
             cocaine use disorder, moderate to severe.

          -  Be a non-treatment seeking cocaine user.

          -  If female and of childbearing potential, must have a negative pregnancy test within 48
             hours of beginning the study and be willing to use acceptable contraception or be
             abstinent for 14 days prior to study, through the entire study and 30 days after study
             participation.

        Exclusion Criteria:

          -  Be seeking treatment for substance abuse.

        (For full inclusion/exclusion criteria or for more information, please contact the site
        directly.)
Study of Testosterone and rHGH in FSHD
Condition: Facioscapulohumeral Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Facioscapulohumeral
Intervention: Testosterone Enanthate; Somatropin
Intervention description: Testosterone enanthate in oil (140mg) delivered via intramuscular injections every 2 weeks.; Genotropin (5.0 μg/kg/day) delivered via subcutaneous injections.
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the safety and tolerability of combination
      therapy with recombinant human growth hormone (rHGH) and testosterone in adult male patients
      with facioscapulohumeral muscular dystrophy (FSHD) over 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A genetically confirmed diagnosis of FSHD (or clinical symptoms suggestive of FSHD
             with a first degree relative with genetically confirmed FSHD)

          -  Hematocrit of ≤ 50%

          -  Prostate-specific antigen ≤ 4.0 ng/ml (or ≤ 3.0 ng/ml if the participant has a
             first-degree relative with prostate cancer)

          -  Fasting blood glucose <126 mg/dl

          -  Able to walk continuously for six minutes (cane, walker, orthoses allowed)

          -  Able to independently administer intramuscular and subcutaneous injections (or have a
             family member who is capable and willing to administer these injections)

        Exclusion Criteria:

          -  Diabetes

          -  Obesity (BMI>35 kg/m2)

          -  Cardiovascular disease (heart failure, coronary artery disease, uncontrolled
             hypertension, untreated hypercholesterolemia)

          -  Untreated thyroid disease

          -  Deep vein thrombosis

          -  Untreated severe sleep apnea

          -  Past pituitary disease

          -  Significant musculoskeletal injury and/or pain that affects walking

          -  A systolic blood pressure over 160 or a diastolic pressure over 100

          -  Plans to dramatically change exercise habits

          -  Liver disease

          -  Renal disease

          -  Cancer (other than basal cell skin cancer)

          -  Plans to conceive

          -  Heavy alcohol use (greater than 50g/day)

          -  Current testosterone or HGH use

          -  Current use of medications that interfere with the growth hormone or gonadal endocrine
             axis.