bioihbjkbjnl/mcl2 huggingface dataset:
A Study of a New LY900014 Formulation in Healthy Participants
Condition: Healthy
Intervention: LY900014; Insulin Lispro (Humalog)
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin Lispro
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 24.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is
      administered by injection under the skin of the abdomen. The study will be conducted in
      healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of
      different doses of LY900014 on blood sugar levels. Side effects and tolerability will be
      documented. The study will last for about 8 to 9 weeks for each participant, including
      screening and follow up. Screening is required within 28 days prior to entering the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy male or a female (not pregnant and agreeable to take birth control
             measures until one month after study completion)

          -  Have a body mass index (BMI) of 18.5 to 30 kilogram per square meter (kg/m^2),
             inclusive, at screening

          -  Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine
             laboratory test results that are acceptable for the study

          -  Are nonsmokers, have not smoked for at least 2 months prior to entering the study, and
             agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the
             duration of the study

        Exclusion Criteria:

          -  Are currently participating in or completed a clinical trial within the last 30 days
             or any other type of medical research judged to be incompatible with this study

          -  Have previously participated or withdrawn from this study

          -  Have or used to have health problems or laboratory test results or ECG readings that,
             in the opinion of the doctor, could make it unsafe to participate, or could interfere
             with understanding the results of the study
Effect of Anagrelide Hydrochloride on Any Changes in Heart Function in Healthy Volunteers
Condition: Healthy
Intervention: Anagrelide 0.5 mg; Anagrelide 2.5 mg; Moxifloxacin; Placebo
Intervention description: 0.5mg Anagrelide single oral dose; 2.5mg Anagrelide single oral dose; 400 mg Moxifloxacin single oral dose; Anagrelide placebo + Moxifloxacin placebo single oral dose
Intervention MeSH terms: Moxifloxacin; Anagrelide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      According to the ICH Guidance Document E14, all non-antiarrhythmic drugs should be evaluated
      for their ability to prolong the QT interval which represents the duration of ventricular
      depolarization and subsequent repolarization. The primary objective of the study is to assess
      the effect of anagrelide on QT/QTc interval following a therapeutic and supratherapeutic dose
      of anagrelide when compared to placebo and a positive control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-45 years inclusive at the time of consent. The date of signing informed consent
             is defined as the beginning of the screening period. This inclusion criteria will only
             be assessed at the screening visit.

          -  Subject is willing to comply with any applicable contraceptive requirements of the
             protocol and is: male, or non-pregnant non lactating female, or females must be at
             least 90 days post-partum or nulliparous.

          -  Satisfactory medical assessment with no clinically or relevant abnormalities in
             medical history, physical examination, vital signs, ECG, and clinical laboratory
             evaluation as assessed by the investigator.

        Exclusion Criteria:

          -  Current or recurrent disease that could affect the action, absorption, or disposition
             of the investigational product, or could affect clinical or laboratory assessments.

             a- Current or relevant history of physical or psychiatric illness, any medical
             disorder that may require treatment or make the subject unlikely to fully complete the
             study, or any condition that presents undue risk from the investigational product or
             procedures.

          -  Significant illness, as judged by the Investigator, within 2 weeks of the first dose
             of investigational product.
A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Users When ALO-02 Capsules Are Crushed and Snorted
Condition: Healthy
Intervention: ALO-02 weight-matched placebo; crushed ALO-02 30 mg/3.6 mg; oxycodone weight-matched placebo; crushed oxycodone IR 30 mg
Intervention description: crushed sugar spheres (powder) x 1 dose; crushed ALO-02 30 mg/3.6 mg capsule x 1 dose; crushed lactose tablets (powder) x 1 dose; Three (3) crushed immediate-release (IR) oxycodone 10 mg tablets x 1 dose
Intervention MeSH terms: Naltrexone; Oxycodone
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Relative abuse potential study; Chronic pain; oxycodone; naltrexone; opioid-related disorders; drug abusers

Summary:

      The main purpose of this study is to determine if oxycodone and naltrexone combination
      capsules (ALO-02) have the potential to be abused when they are crushed and snorted.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects

          -  Non-dependent, recreational opioid users. (Must use opioid for non-therapeutic
             purposes on at least 10 occassions within the last year and at least once in the 8
             weeks before Visit 1 (Screening Visit).

          -  Must have experience with intranasal opioid administration (snorted opioid drugs on at
             least 3 occassions within the last year before Visit 1 (Screening Visit).

        Exclusion Criteria:

          -  Diagnosis of substance and/or alcohol dependence

          -  Subject has participated in, is currently participating in, or seeking treatment for
             substance and/or alcohol related disorder.
Study of an Experimental New Drug, PPARγ Agonist Taken by Mouth by Participants With Advanced or Metastatic Cancer
Condition: Neoplasm
Intervention: CS-7017
Intervention description: CS-7017 0.05mg and 1.0mg tablets
Intervention MeSH terms: Efatutazone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PPARγ agonist; advanced or metastatic malignancies; Tumor; Cancer

Summary:

      An open-label, Phase I, dose escalation study of CS-7017 administered by mouth in sequential
      cohorts of 3 to 6 participants with advanced or metastatic malignancies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically diagnosed advanced or metastatic malignancy that is
             refractory to, not curable with, or not eligible for standard treatment(s).

          -  18 years or older

          -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.

          -  Resolution of any toxic effects of prior therapy (except alopecia) to National Cancer
             Institute Common Terminology Criteria for Adverse Events v3.0 grade less than or equal
             to 1.

          -  Adequate organ and bone marrow function.

          -  Willing to use effective contraceptive while on treatment through at least 3 months
             thereafter.

          -  Negative pregnancy test for females of childbearing potential.

          -  Echocardiogram with ejection fraction within normal range.

        Exclusion Criteria:

          -  Anticipation of need for a major surgical procedure or radiation therapy during the
             study.

          -  Treatment with chemotherapy, hormonal therapy, other thiazolidinediones, radiotherapy,
             minor surgery, or any investigational agent within 4 weeks (6 weeks for nitrosoureas,
             mitomycin C, immunotherapy, biological therapy, or major surgery) of study treatment
             start.

          -  Participants with clinically significant pleural or pericardial effusion (participants
             with minimal pleural effusion may be eligible at the Investigator's discretion).

          -  Clinically significant active infection, which requires antibiotic therapy, or human
             immunodeficiency virus (HIV)-positive participants receiving antiretroviral therapy.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Participants With Type 2 Diabetes (MK-8655-002)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: MK-8655; Placebo
Intervention description: Participants will receive MK-8655 as a single dose on Day 1. Participants will receive MK-8655, once a day (q.d.), for 14 consecutive days (Day 3 through Day 16). MK-8655 doses may be adjusted downward based on the results of ongoing studies.; Participants will receive Placebo as a single dose on Day 1. Participants will receive Placebo, q.d., for 14 consecutive days (Day 3 through Day 16).
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes

Summary:

      This study will assess the initial safety, tolerability, pharmacokinetics, and
      pharmacodynamics of MK-8655, after single and multiple daily oral administrations to
      participants with Type 2 Diabetes (T2DM). The study will assess the reduction in fasting
      plasma glucose concentrations from baseline after multiple daily administrations of MK-8655.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female of non-child bearing potential

          -  Body Mass Index ≤40 kg/m^2

          -  Diagnosis of Type 2 Diabetes (T2DM) and is either drug naive or is being treated with
             metformin only

          -  In good health except for T2DM

          -  Willing to follow a standard diet

          -  Nonsmoker and/or no use of nicotine or nicotine-containing products for 6 months

        Exclusion Criteria:

          -  Mentally or legally incapacitated

          -  History of stroke, chronic seizures, or major neurological disorder

          -  History of clinically significant endocrine (except T2DM), gastrointestinal,
             cardiovascular, hematological, hepatic, immunological, renal, respiratory, or
             genitourinary abnormalities or diseases

          -  History of neoplastic or myeloproliferative diseases

          -  Has clinical unstable or rapidly progressing diabetic retinopathy, neuropathy, and/or
             frequent nausea, bloating or vomiting, severe gastroesophageal reflux or early satiety

          -  Has a history of Type 1 Diabetes and/or history of ketoacidosis

          -  Use of any lipid-lowering therapies in the past 3 months

          -  Non-permitted medication for a co-morbid condition

          -  Excessive alcohol or caffeine use

          -  Participation in another investigational study within 4 weeks prior to this study

          -  A history of significant multiple and/or severe allergies or anaphylactic reactions

          -  Regular user of any illicit drugs or history of alcohol abuse within 6 months
To Investigate the Safety, Tolerability, Pharmacokinetics and the Relative Bioavailability of BI 1026706
Condition: Healthy
Intervention: BI 1026706 Placebo; BI 1026706
Intervention description: Placebo to BI 1026706; different dose formulations
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Enrollment: 80.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To investigate the safety, tolerability, pharmacokinetics and the relative bioavailability of
      BI 1026706
    

Eligibility criteria:

        Inclusion criteria:

        1. healthy male subjects

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions
A Pharmacokinetic Study of MK-0941 After Multiple Daily Doses in Subjects With Type 2 Diabetes (MK-0941-012)(COMPLETED)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: MK-0941; Comparator: Placebo
Intervention description: Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.; Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      A study to test the pharmacokinetics after twice daily administration of MK-0941 or placebo
      in subjects with type 2 diabetes who have inadequate control on metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a BMI < 42 kg/m2

          -  Subject is taking >1500 mg metformin per day for at least 8 weeks

          -  Subject has HbA1c value of 7.0% and < 11% at screening

          -  Subject is willing to follow AHA weight maintaining diet and exercise program

          -  Subject is a nonsmoker for at least 6 months

        Exclusion Criteria:

          -  Subject has type 1 diabetes

          -  Subject has a history of stroke or chronic seizure

          -  Subject has a history of neoplastic disease

          -  Subject has a history of gastrointestinal, cardiovascular, blood, liver kidney,
             respiratory, immunological or genitourinary disorders or diseases

          -  Subject is currently taking 2 or more diabetes medications

          -  Subject has glaucoma or is blind

          -  If female, subject is pregnant or breastfeeding

          -  Subject consumes > 3 alcoholic beverages per day

          -  Subject has had major surgery or has donated blood in the last 4 weeks
A Study To Assess The Safety Of PF-06342674 In Adults With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Placebo; PF-06342674 Dose A; PF-06342674 Dose B; PF-06342674 Dose C; PF-06342674 Dose D
Intervention description: Placebo; Multiple SC Doses; Multiple SC Doses; Multiple SC Doses; Multiple SC Doses
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Masking: Double (Participant, Investigator)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phase 1; RN168; Adults; Type 1 Diabetes; T1D

Summary:

      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and
      immunogenicity of multiple doses of PF-06342674. Several dose levels will be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women and men age 18 and older.

          -  Diagnosis of type 1 diabetes within 2 years of randomization.

          -  Peak stimulated C-peptide levels ≥ 0.15 ng/mL.

        Exclusion Criteria:

          -  Anticipated ongoing use of diabetes medications other than insulin.

          -  Evidence or history of diabetic complications with significant end-organ damage.

          -  Episode of severe hypoglycemia within 60 days of randomization.

          -  Multiple hospitalizations for diabetic ketoacidosis.
Pharmacokinetics of Dabigatran Etexilate (Pradaxa®) During Haemodialysis
Condition: Cardiovascular Diseases; Kidney Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Cardiovascular Diseases
Intervention: Dabigatran etexilate; Dabigatran etexilate; Dabigatran etexilate
Intervention description: 150 mg capsule; 75 mg capsule; 110 mg capsule
Intervention MeSH terms: Dabigatran
Phase: Phase 1
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The current study will allow the assessment of pharmacokinetics, pharmacodynamics,
      elimination rate and clearance of dabigatran etexilate during and following haemodialysis in
      ESRD patients.
    

Eligibility criteria:

        Inclusion criteria:

          -  End stage renally disease (ESRD), undergoing haemodialysis

          -  ESRD patients in relatively good health

          -  Age 21 - 60 years inclusive

          -  Signed and dated written informed consent prior to admission to the study

        Exclusion criteria:

          -  Clinically relevant laboratory or physical examination abnormalities (except for renal
             function tests or deviation of clinical laboratory values) that are related to renal
             impairment

          -  Moderate and severe concurrent liver function impairment

          -  Surgery of gastrointestinal tract (except appendectomy or herniotomy) or evidence of
             significant gastrointestinal motility problems

          -  Recent or contemplated diagnostic or therapeutic procedures with potential for
             uncontrollable bleeding

          -  Intake of medication, which influences the blood clotting

          -  Subjects not able to understand and comply with protocol requirements, instructions
             and protocol-stated restrictions

          -  For women with childbearing potential: no reliable contraception

          -  Participation in another trial with an investigational drug (<2 months prior to
             administration or during trial)

          -  Scheduled to receive a donor kidney transplant during the course of the study
A Drug Interaction Study of Lanabecestat (LY3314814) and Warfarin in Healthy Participants
Condition: Healthy
Intervention: Lanabecestat; Warfarin
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Warfarin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to look at how much warfarin gets into the blood stream and how
      long it takes the body to get rid of it when given both with and without lanabecestat.
      Another purpose is to evaluate the effectiveness of warfarin therapy to prevent blood clots
      when given with lanabecestat by measuring international normalized ratio (INR). INR measures
      the time it takes for blood to clot and compares it to an average. Information about any side
      effects that may occur will also be collected. The study will last about 5 weeks from the
      first dose to follow-up for each participant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male participants: will be sterile (including vasectomy) or agree to use an effective
             method of birth control and will not donate sperm during the study and for 3 months
             following the last dose of the investigational product

          -  Female participants: women not of childbearing potential

        Exclusion Criteria:

          -  Have a history of or current, significant ophthalmic disease, as determined by the
             investigator or ophthalmologist

          -  Have vitiligo or any other clinically significant disorder of skin pigmentation as
             determined by the investigator or dermatologist

          -  Have a history or presence of significant bleeding disorders

          -  Have a history of gastrointestinal ulcers with hemorrhage

          -  Have a personal or family history of coagulation or bleeding disorders or reasonable
             suspicion of vascular malformations

          -  Self-reported history of increased bleeding from trauma

          -  Have a history of major head trauma (with loss of consciousness) within the past year
             or minor head trauma (without loss of consciousness) within the last 3 months prior to
             screening

          -  History of major surgery within 3 months of screening

          -  Planned surgery within 14 days after the last day of dosing

          -  International Normalized Ratio (INR)/ Prothrombin Time (PT) or activated partial
             thromboplastin time above the normal reference range at screening

          -  Abnormal Protein S antigen and/or Protein C activity as determined by the investigator

          -  History of deep vein thrombosis and/or pulmonary embolism