bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of Fixed-dose Combinations and Coadministered Individual Tablets of Saxagliptin/Metformin-Brazil
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Saxagliptin/metformin fixed-dose combination (FDC); Saxagliptin; Metformin extended-release (XR); Saxagliptin/Metformin FDC; Metformin
Intervention description: Tablet, oral, 5 mg/500 mg FDC, once on Day 1 only, 1 day; Tablet, oral, 5 mg, once on Day 1 only, 1 day; Tablet, oral, 500 mg, once on Day 1 only, 1 day; Tablet, Oral, 5 mg/1000 mg FDC, once on Day 1 only, 1 day; Tablet, oral, 1000 mg, once on Day 1 only, 1 day
Intervention MeSH terms: Metformin; Saxagliptin
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin,
      5-mg/metformin extended-release (XR), 500-mg, fixed-dose combination (FDC) tablet with
      saxagliptin, 5-mg and metformin, 500-mg XR tablets administered together in both the fasted
      and fed states. In addition, to demonstrate the bioequivalence of saxagliptin and metformin
      in a saxagliptin, 5-mg/metformin XR, 1000-mg, FDC tablet with saxagliptin, 5-mg and
      metformin, 1000-mg XR tablets administered together in both the fasted and fed states.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Healthy men and women

          -  women of childbearing potential who are using acceptable method of contraception

          -  Women who are not pregnant or nursing

          -  Body Mass Index (BMI) of 18 to 29.9 kg/m^2, inclusive. BMI=weight(kg)/height(m)^2.

        Key Exclusion Criteria:

          -  Any significant acute or chronic medical illness.

          -  History of gastrointestinal (GI) disease

          -  Major surgery within 4 weeks of study drug administration

          -  Any GI surgery that could impact study drug absorption

          -  Donation of blood or plasma to a blood bank or in a clinical study (except a screening
             visit) within the 6 months of study drug administration.

          -  Blood transfusion within 3 months of study drug administration for women and within 2
             months for men

          -  Inability to be venipunctured and/or tolerate venous access

          -  Current smoker or recent (within 1 month) history of regular tobacco use

          -  Recent (within 6 months of study drug administration) drug or alcohol abuse

          -  Participation in a bioequivalence study within the last 6 months of study drug
             administration

          -  Estimated creatinine clearance of <80 mL/min using Cockcroft-Gault formula

          -  History of allergy to drug class or related compounds

          -  History of allergy to metformin or other similar acting agents

          -  History of any significant drug allergy
A Study to Compare 2 Formulations of LY900014 in Healthy Participants
Condition: Healthy
Intervention: LY900014-U200; LY900014-U100
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: Double (Participant, Investigator)
Enrollment: 49.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study involves a comparison of a LY900014 U-200 formulation with a LY900014 U-100
      formulation. LY900014 is a type of fast acting insulin. Study participants will be
      administered LY900014 U-100 two times and LY900014 U-200 two times, over 4 study periods, by
      injection under the skin. Blood samples will be taken to compare how the body handles the
      study drugs and how they affect the blood sugar levels. Side effects and tolerability will be
      documented. The study will last about 4 weeks, not including screening and follow up.
      Screening is required within 28 days prior to the start of the study and follow up is
      required at least 2 weeks after the last dose of study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or a female (not pregnant and agreeable to take birth control measures
             until study completion)

          -  Have a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m²)

          -  Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine
             laboratory test results that are acceptable for the study

          -  Have veins suitable for easy blood collection and glucose solution infusion

        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

          -  Had blood loss of more than 450 milliliters (mL) within the last 3 months

          -  Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week
             (female)

          -  Smoke more than 10 cigarettes per day

          -  Are infected with hepatitis B or human immunodeficiency virus (HIV)

          -  Are taking illegal drugs
Ph I Ipilimumab Vemurafenib Combo in Patients With v-Raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF)
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Ipilimumab (BMS-734016); Vemurafenib
Intervention description: Injection, intravenous (i.v.), cohort 1: 3 mg/kg, Escalate to cohort 2: 10 mg/kg, Escalate to cohort 3: at Recommended Phase 2 Dose (RP2D), De-escalate cohort 1A: 3 mg/kg, De-escalate cohort -1B: 10 mg/kg, (every three week) Q3wk, upto 2 yrs; tablets, oral, cohort 1: 960 mg Twice daily (BID) x 28 days after date, cohort 2: 960 mg BID x 28 days after date, cohort 3: at Recommended Phase 2 Dose (RP2D) x 14 days after date, De-escalate cohort 1A: 720 mg BID x 28 days after date, De-escalate cohort -1B: 720 mg BID x 28 days after date , Up to 2 yrs
Intervention MeSH terms: Ipilimumab; Vemurafenib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Treatment of subjects who have metastatic melanoma that expresses an activated mutant form of
      the BRAF oncogene (V600E) with a combination of the specific BRAF inhibitor, Vemurafenib, and
      the Cytotoxic T Lymphocyte Antigen 4 (CTLA-4) inhibitor mAb Ipilimumab will be safe and
      feasible and will show preliminary evidence of anti-tumor efficacy and survival in comparison
      to historical results following treatment with either agent alone.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  Metastatic melanoma with activating V600 BRAF mutation

          -  Measurable Tumor

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1

        Exclusion Criteria:

          -  Autoimmune disease

          -  Active Brain Metastasis (must be stable after radiation for at least one month)

          -  Prior therapy with immune stimulating agents
First-in-Human Trial of Single Ascending Dose, Multiple Ascending Dose and Malaria Challenge Model in Healthy Participants
Condition: Healthy
Intervention: M5717; Placebo; M5717
Intervention description: Participants received single ascending oral dose of M5717 after at least 8 hours of fasting together with water on Day 1, followed by a 4-hour post-dose fast; Participants received placebo matched to M5717; Participants received single ascending oral dose of M5717 from Part A after at least 8 hours of fasting together with water on Day 1, followed by a 4-hour post-dose fast
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy Participants; M5717; Malaria; Plasmodium falciparum

Summary:

      The primary purpose of this study was to investigate the safety and tolerability of M5717 and
      to characterize the Pharmacokinetics (PK) /Pharmacodynamic relationship between M5717 PK and
      parasite clearance in healthy participants following infection with Plasmodium falciparum.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult men and women of non-childbearing potential, with total body weight greater than
             or equal to 50.0 kilogram and body mass index (BMI) between 19.0 kilogram per meter
             square(kg/m^2) and 29.9 kg/m^2.

          -  Healthy as assessed by the Investigator with no clinically significant abnormality
             identified on physical examination or laboratory evaluation and no active clinically
             significant disorder, condition, infection or disease that would pose a risk to
             participant safety or interfere with the trial evaluation, procedures, or completion.

          -  Other protocol defined inclusion criteria could apply.

        Exclusion Criteria:

          -  Participants with history or presence of clinically relevant respiratory,
             gastrointestinal, renal, hepatic, hematological, lymphatic, neurological,
             cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological
             dermatological, connective tissue diseases or disorders.

          -  Participants with history of relevant drug hypersensitivity, ascertained or
             presumptive allergy/hypersensitivity to the active drug substance and/or formulation
             ingredients; history of serious allergic reactions leading to hospitalization or any
             other allergic reaction in general, which the Investigator considers may affect the
             safety of the participant and/or outcome of the trial.

          -  Participants who have any history of malaria.

          -  Participants who have participated in a previous malaria vaccine trial.

          -  Participants who have participated in a previous human malaria challenge trial.
A Study Of 4-1BB Agonist PF-05082566 Plus PD-1 Inhibitor MK-3475 In Patients With Solid Tumors (B1641003/KEYNOTE-0036)
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Intervention: PF-05082566; MK-3475
Intervention description: Starting dose of 0.45 mg/kg q3wks IV, dose escalation; 2 mg/kg q3wks, IV
Intervention MeSH terms: Pembrolizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Solid Tumors

Summary:

      This is a safety, pharmacokinetic and pharmacodynamic study designed to estimate the maximum
      tolerated dose (MTD), and determine the Recommended Phase 2 Dose (RP2D) of PF-05082566, a
      4-1BB agonist monoclonal antibody (mAb), in combination with MK-3475, a PD-1 inhibitor in
      patients with solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy
             which has progressed on standard therapy or for which no standard therapy is
             available.

          -  Measurable disease per RECIST v1.1.

          -  Adequate bone marrow, renal and liver functioning

        Exclusion Criteria:

          -  CNS primary malignancies, active seizure disorder or spinal cord compression, or
             carcinomatous meningitis.

          -  History of any of the following toxicities associated with a prior immunotherapy:

               -  Grade 3 immune mediated adverse event that was considered related to previous
                  immunotherapy and required immune suppressive therapy;

               -  Grade 2 hepatic function related adverse event that persisted more than 1 week,
                  was considered related to immunotherapy, or required treatment discontinuation or
                  immunosuppressive therapy

          -  Any of the following within the 12 months prior to registration: myocardial
             infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic
             congestive heart failure, cerebrovascular accident or transient ischemic attack and 6
             months for deep vein thrombosis or pulmonary embolism.

          -  History of or known presence of extensive, disseminated/bilateral or Grade 3 or 4
             interstitial fibrosis or interstitial lung disease, including a history of
             pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung
             disease, obliterative bronchiolitis, or pulmonary fibrosis, but not including a
             history of prior radiation pneumonitis. Patients with clinically significant lung
             disease requiring oxygen therapy (eg, COPD).
Pharmacokinetic Study of an Acute Gout Regimen
Condition: Pharmacokinetics
Intervention: colchicine tablets
Intervention description: colchicine 1.2mg initially; then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours)
Intervention MeSH terms: Colchicine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: healthy; blood levels

Summary:

      This study aims to characterize the pharmacokinetic profile of colchicine after a regimen of
      1.8 mg over two hours. A secondary goal is to evaluate the safety and tolerability of this
      regimen in healthy volunteers. To this end, all study subjects will be monitored for adverse
      effects throughout the entire study period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults 18-55 years of age, non smoking and non-pregnant (postmenopausal,
             surgically sterile or using effective contraceptive measures) weighing at least 55kg
             and within 15% of ideal body weight.

        Exclusion Criteria:

          -  Recent participation (within 30 days) in other research studies

          -  Recent significant blood donation

          -  Pregnant or lactating

          -  Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface
             antigen (HbsAg), or hepatitis C virus (HCV)

          -  Recent (2-year) history or evidence of alcoholism or drug abuse

          -  History or presence of significant cardiovascular, pulmonary, hepatic, renal,
             haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological,
             or psychiatric disease

          -  Subjects who have used any drugs or substances known to inhibit or induce cytochrome
             (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 30 days prior to the first dose
             and throughout the study
Phase 1 Safety, Pharmacokinetics And Pharmacodynamics Study Of Recombinant Factor VIIa Variant (813d) In Adult Subjects With Hemophilia
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: PF-05280602; PF-05280602; PF-05280602; PF-05280602; PF-05280602
Intervention description: 0.5 micrograms per kilogram of PF-05280602, IV infusion, single dose; 4.5 micrograms per kilogram of PF-05280602, IV infusion, single dose; 9.0 micrograms per kilogram of PF-05280602, IV infusion, single dose; 18.0 micrograms per kilogram of PF-05280602, IV infusion, single dose; 30.0 micrograms per kilogram of PF-05280602, IV infusion, single dose
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: The was an ascending dose trial with one open label treatment, intervention model was sequential dose escalation.
Masking: None (Open Label)
Enrollment: 29.0
Sex: Male
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Phase 1; Safety; Pharmacokinetic; Pharmacodynamic

Summary:

      This study hypothesizes that the study drug, PF-05280602 (at the selected doses) will be safe
      to administer to subjects with severe Hemophilia A or B with or without inhibitors and will
      demonstrate evidence of hemostatic activity. This is supported by the preclinical findings in
      hemophilic animal models.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male subjects 18 to <65 years old with severe hemophilia A or B with or without
             inhibitors to FVIII or FIX.

          -  Subjects is willing and able to comply with the mandatory washout periods prior to
             screening and prior to dosing and through 48 hours post dosing. At screening this
             includes a washout of FIX for 96 hours and FVIII for 72 houts. At dosing this includes
             a washout of FIX for 96 hours and FVIII and other hemostatic agents for 72 hours
             through 48 hours post dosing.

          -  Subjects must agree and commit to using a a highly effective method of birth control
             from the time of screening through four weeks after study drug administration.

        Exclusion Criteria:

          -  Presence of a bleeding disorder in addition to hemophilia A or B.

          -  Regular, concomitant therapy with immunomodulating drugs (eg, intravenous
             immunoglobulin, and routine systemic corticosteroids).

          -  History of coronary artery disease, thrombolic disease or diagnosis of prothrombic
             disorder.
4-Week, Multiple-dose, Dose-escalating Study In Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; PF-06882961; PF-06882961; PF-06882961; PF-06882961; PF-06882961; PF-06882961; PF-06882961; PF-06882961
Intervention description: Tablet, 0 mg, twice daily, 28 days; Tablet, 15 mg twice daily, 28 days; Tablet, 50 mg twice daily, 28 days; Tablet, 150 mg twice daily, 28 days; Tablet, 300 mg twice daily, 28 days; Tablet, dose TBD, twice daily, Cohort 5, 28 days; Tablet, dose TBD, twice daily, Cohort 6, 28 days; Tablet, dose TBD, twice daily, Cohort 7, 28 days; Tablet, dose TBD, twice daily, Cohort 8, 28 days
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Type 2 diabetes mellitus

Summary:

      This is a dose-escalating study in patients with Type 2 diabetes on metformin. Participants
      will receive an investigational product or placebo for 28 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes treated with a stable dose of metformin at least 500 mg

          -  HbA1c value between 7.0 and 10.5%

        Exclusion Criteria:

        - Type 1 diabetes or secondary forms of diabetes
Tolerability and Efficacy of Ibuprofen 800 mg in a Walking Model of Osteoarthritis Pain (0000-057)
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: ibuprofen; Placebo
Intervention description: Patients will receive 800 mg ibuprofen in one of the three treatment periods.; Patients will receive placebo to ibuprofen in two of the three treatment periods.
Intervention MeSH terms: Ibuprofen
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to see if generic ibuprofen has an effect on osteoarthritis knee
      pain during a series of timed walks on a treadmill.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The primary source of pain is the study knee of one lower extremity

          -  Patient is willing to limit alcohol and caffeine intake

          -  Aside from osteoarthritis, patient is in generally good health

          -  Patient is capable of completing protocol specified walks

          -  Patient is able to understand and complete questionnaires in English

          -  Patient has previously benefited from the use of either NSAIDs, COX-2 inhibitors, or
             acetaminophen

        Exclusion Criteria:

          -  Patient has another condition which could interfere with evaluating pain in the knee
             being tested

          -  Patient is not able to take a non-steroidal anti-inflammatory drug (NSAID) such as
             ibuprofen

          -  Patient has a history or current evidence of stroke, transient ischemic attack, liver
             disease or cancer

          -  Patient has a history or current evidence of dizziness, unsteadiness, or falling

          -  Patient has congestive heart failure, unstable angina or uncontrolled high blood
             pressure

          -  Patient has a history of stomach, digestive track, or small intestine surgery

          -  Patient is unable to complete the study questionnaires in English