bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of Fixed Dose Combination of 2.5 mg Saxagliptin/850 mg Metformin Tablet Relative to 2.5 mg Onglyza and 850 mg Glucophage Tablets Co-Administered
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: saxagliptin; metformin; saxagliptin + metformin (FDC tablet)
Intervention description: Tablets, Oral, 2.5 mg, once daily, single dose; Tablets, Oral, 850 mg, once daily, single dose; Tablet, oral, (saxagliptin 2.5 mg) (metformin 850 mg), once daily, single dose
Intervention MeSH terms: Metformin; Saxagliptin
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To demonstrate bioequivalence of a 2.5 mg saxagliptin/850 mg metformin fixed dose combination
      (FDC) tablet relative to the 2.5 mg saxagliptin tablet and 850 mg metformin (Glucophage
      Marketed by Merck-Serono) tablet co-administered to healthy subjects in the fasted and fed
      condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ages 18 to 55 inclusive

          -  Healthy subjects as determined by no clinically significant deviation from normal in
             medical history, physical examination, electrocardiograms (ECGs), and clinical
             laboratory determinations

          -  Body Mass Index (BMI) of 18 to 32 kg/m^2, inclusive. BMI = weight (kg)/ [height (m)]^2

        Exclusion Criteria:

          -  Any significant acute or chronic medical illness

          -  Current or recent (within 3 months) gastrointestinal disease

          -  Any major surgery within 4 weeks of study drug administration

          -  History of allergy to a dipeptidyl peptidase-IV (DPP4) inhibitor or related compound

          -  History of allergy or intolerance to metformin or other similar acting agents

          -  Prior exposure to saxagliptin

          -  Prior exposure to metformin within 3 months of study drug administration

          -  Estimated creatinine clearance (Clcr) of < 80 mL/min using the Cockcroft Gault formula
Drug-Drug Interaction Study Between Colchicine and Diltiazem ER
Condition: Healthy; Adult; Volunteer; Colchicine; Pharmacokinetics; Diltiazem; Cytochrome p450 3A4; P-glycoprotein
Intervention: Colchicine; Diltiazem ER; Colchicine
Intervention description: A single dose of 0.6 mg colchicine administered alone at 7:15 am on Day 1 after an overnight fast of at least 10 hours.; One 240 mg diltiazem ER capsule administered daily at 7:15 am on Days 15 to 21.; A single dose of 0.6 mg colchicine administered along with diltiazem ER at 7:15 am on Day 21 after an overnight fast of at least 10 hours.
Intervention MeSH terms: Colchicine; Diltiazem
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: healthy; adult; volunteer; colchicine; diltiazem; blood levels over time

Summary:

      Colchicine is a substrate for both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp).
      Extended-release diltiazem (diltiazem ER) is a potent inhibitor of both CYP3A4 and P-gp. This
      study will evaluate the effect of multiple doses of diltiazem ER on the pharmacokinetic
      profile of a single 0.6 mg dose of colchicine. A secondary objective is to evaluate the
      safety and tolerability of this regimen in healthy volunteers. All study subjects will be
      monitored for adverse events throughout the study period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults 18-45 years of age, non-smoking and non-pregnant (post-menopausal,
             surgically sterile or using effective contraceptive measures) with a body mass index
             (BMI) greater than or equal to 18 and less than or equal to 32, inclusive.

        Exclusion Criteria:

          -  Recent participation (within 28 days) in other research studies

          -  Recent significant blood donation or plasma 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, gallbladder or
             biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic,
             dermatologic, neurologic, 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 28 days prior to the first dose
             and throughout the study

          -  Drug allergies to colchicine or diltiazem.
A Safety Study of MM-121 With Cetuximab and Irinotecan in Patients With Advanced Cancers
Condition: Colorectal Cancer; Squamous Cell Head and Neck Cancer; Non-small Cell Lung Cancer; Triple Negative Breast Cancer; Other Tumors With EGFR Dependence
MeSH terms: Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Head and Neck Neoplasms; Triple Negative Breast Neoplasms
Intervention: MM-121; Irinotecan; Cetuximab
Intervention description: escalating doses MM-121 IV QW; 180 mg/m2 IV Q2W; escalating doses cetuximab IV QW
Intervention MeSH terms: Irinotecan; Cetuximab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic Colorectal cancer; Kras wild-type; Squamous cell head and neck cancer; Non-small cell lung cancer; Triple negative breast cancer; EGFR; ErbB3; MM-121; Cetuximab; Irinotecan

Summary:

      The purpose of this study was to evaluate the safety and tolerability of escalating doses of
      the MM-121 plus cetuximab and the MM-121 plus cetuximab plus irinotecan combination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  No standard options remaining

          -  Adequate liver and kidney functions

          -  18 years of age or above

        Exclusion Criteria:

          -  History of any secondary active cancer in the last 3 years.

          -  Pregnant or breast feeding

          -  History of severe allergic reactions or contraindications to cetuximab or irinotecan
Phase I Trial of Vorinostat (MK-0683, SAHA) in Combination With Decitabine in Patients With AML or MDS (MK-0683-055 EXT1)
Condition: Leukemia, Myelocytic, Acute Myelodysplastic Syndromes; Myelodysplastic Syndromes
MeSH terms: Leukemia; Preleukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Syndrome
Intervention: vorinostat; decitabine
Intervention MeSH terms: Decitabine; Vorinostat
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Leukemia; Myelocytic; Acute Myelodysplastic Syndromes

Summary:

      This study is to evaluate the safety and tolerability of vorinostat in combination with
      decitabine as well as the in vivo molecular and biological effects of vorinostat in patients
      with refractory or relapsed Acute Myelogenous Leukemia (AML) and intermediate or high risk as
      defined by International Prognostic Scoring System (IPSS) Myelodysplastic Syndrome (MDS).
      Participants with Acute Myelogenous Leukemia or Myelodysplastic Syndrome are eligible.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is at least 18 years old with refractory/relapsed AML

               -  If untreated AML, patient is older than 60 years old and not a candidate for
                  standard chemotherapy

          -  Patient is at least 4 weeks from prior treatment and has recovered from all prior
             treatment side effects

          -  Patient has no known liver or kidney problems

          -  Patient knows of no reason they can not receive transfusions of blood clotting cells
             (platelets)

          -  Patient is able to swallow capsules

          -  Patients both male and female are willing to practice birth control during the study

        Exclusion Criteria:

          -  Patient has received prior treatment with valproic acid, decitabine or azacitidine

          -  Being is less than 18 years of age or if patient has untreated AML is below 60 years
             of age

          -  Patient is a women who is pregnant or breastfeeding. Patient has an active infection
             that requires antibiotics

          -  Patient has uncontrolled illness including but not limited to the following: heart
             problems (congestive heart failure, unstable angina pectoris, cardiac arrhythmia),
             inflammation of the pancreas; a mental or social condition that may interfere with
             patient following study procedures

          -  Patient has known human immunodeficiency virus (HIV) infection or HIV-related
             malignancy. Patient has a known history of hepatitis B or C infection

          -  Patient currently has another active cancer other than certain types of skin cancer

          -  Patient is heterosexual and able to have a child and is unwilling to practice birth
             control during the study
A Study of LY900014 Versus Insulin Lispro (Humalog) on High Blood Sugar in Participants With Type 1 Diabetes Who Use Insulin Pumps
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY900014; Insulin Lispro
Intervention description: Administered by CSII; Administered by CSII
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: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to compare LY900014 to insulin lispro (Humalog) in
      participants with type 1 diabetes who are using an insulin pump and have high blood sugar
      after eating. For each participant, the study will last about two to nine weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants with type 1 diabetes

          -  Body mass index (BMI) between 18.5 and 30.0 kilograms per square meter, inclusive

          -  Hemoglobin A1c (HbA1c) less than or equal to 8.5 percent (%)

          -  Using CSII and stable insulin regimen for at least 3 months prior to inclusion into
             the trial

        Exclusion Criteria:

          -  Known or suspected hypersensitivity to investigational medical product(s) or related
             products

          -  Receipt of any medicinal product in clinical development within 30 days or at least 5
             half-lives of the related substances and their metabolites (whichever is longer)
             before randomization in this trial

          -  Known slowing of gastric emptying and or gastrointestinal surgery that, in the opinion
             of the investigator, might change gastrointestinal motility and food absorption

          -  Proliferative retinopathy or maculopathy as judged by the Investigator based on a
             recent (less than 1.5 years) ophthalmologic examination

          -  Widespread subcutaneous lipodystrophy in the abdomen

          -  Current use of any glucose-lowering agents other than insulin within 3 months prior to
             screening

          -  Chronic or recent use of corticosteroids
A Study of Single Dose MK-3614 (MK-3614-001)(COMPLETED)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: MK-3614; Comparator: Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will determine if MK-3614, given as single doses, is safe and well tolerated in
      healthy males and male participants with mild to moderate hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy participants between 18 to 45 years of age; otherwise healthy participants
             between 18 to 55 years of age newly diagnosed with grade 1 or 2 hypertension

          -  Participant is in good general health

          -  Participant is a nonsmoker

        Exclusion Criteria:

          -  Participant has a history of stroke, seizure or major neurological disease

          -  Participant has functional disability that can interfere with rising from a sitting
             position to a standing position

          -  Participant has a family history of a bleeding or clotting disorder

          -  Participant has a history of cancer

          -  Participant is unable to refrain from or anticipates the use of any prescription or
             non-prescription medication during the study

          -  Participant consumes excessive amounts of alcohol or caffeine

          -  Participant has had major surgery, donated blood or participated in another
             investigational study in the past 4 weeks.
Eletriptan Pharmacokinetics In Korean Males
Condition: Healthy
Intervention: Eletriptan commercial tablet; Eletriptan commercial tablet; Eletriptan commercial tablet; Eletriptan commercial tablet
Intervention description: 20 mg tablet, single dose; 40 mg tablet, single dose of 1 X 40 mg; 40 mg tablet, single dose of 2 X 40 mg; 40 mg tablet, 1 X 40 mg given two times: the second 2 hours after the first
Intervention MeSH terms: Eletriptan
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pharmacokinetic; eletriptan; Korean; crossover

Summary:

      The hypothesis of this study is that Korean subjects have similar Pharmacokinetics (PK)
      characteristics to those seen in other populations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy male subjects, 18-55 years old

          -  Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

          -  provide informed consent

        Exclusion Criteria:

          -  blood pressure >140/90 mm Hg

          -  any condition possibly affecting drug absorption

          -  positive urine drug screen
Pharmacokinetic Study of Oral ALXN1840 in Japanese and Non-Japanese Adult Healthy Participants
Condition: Wilson Disease
MeSH terms: Hepatolenticular Degeneration
Intervention: ALXN1840
Intervention description: Tablet for oral use.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of the study is to confirm how long ALXN1840 stays in the body of Japanese
      and non-Japanese healthy participants (that is, pharmacokinetic [PK] profile).
    

Eligibility criteria:

        Key Inclusion Criteria: - Body weight ≤80 kilograms (kg) and body mass index (BMI) within
        the range 18-25 kg/m^2, inclusive, at screening. - Negative serum pregnancy test. - Female
        participants of childbearing potential and male participants with a female spouse or
        partner of childbearing potential must be willing to follow protocol-specified
        contraception guidance starting at least one menstrual cycle before first study drug
        administration and continuing for up to 3 months after the end of systemic exposure of the
        study drug (that is, 3 months after end of study visit).

        Key Exclusion Criteria: - Current or recurrent/chronic disease (for example,
        cardiovascular, hematological, neurological, endocrine, immunological, rheumatological,
        renal, hepatic, or gastrointestinal (GI) or other conditions) that or could affect clinical
        assessments or clinical laboratory evaluations. - Current or relevant history of physical
        or psychiatric illness that are not stable or may require a change in treatment, use of
        prohibited therapies during the study or make the participant unlikely to fully comply with
        the requirements of the study or complete the study, or any condition that presents undue
        risk from the study drug or study procedures. - Any other significant disease or disorder
        which, in the opinion of the Investigator, may put the participant at risk. - History of
        significant allergic reaction (for example, anaphylaxis or angioedema) to any product (for
        example, food, pharmaceutical). - Use of prescription medications (excluding oral
        contraceptives) within 14 days prior to dosing on Day 1, except with prior approval of
        Alexion. - Use of non-prescription/ over-the-counter medications including vitamins and
        dietary or herbal supplements, within 7 days prior to dosing on Day 1. - Donated or lost
        400 milliliters (mL) blood or more within the last 16 weeks preceding the first day of
        dosing.
Study To Assess The Effect Of Gabapentin, Diphenhydramine And Morphine On Cold Pain In Healthy Male Volunteers
Condition: Healthy
Intervention: Gabapentin; Diphenhydramine; Morphine; Placebo
Intervention description: Capsule, single 1200mg dose; Tablet, single 50mg dose; IV, single 10mg dose; Placebo formulations (Capsule, tablet, IV to match the active treatments and to be administered in a double-dummy fashion).
Intervention MeSH terms: Diphenhydramine; Promethazine; Morphine; Gabapentin
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 19.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cold pain methodology; Healthy male volunteers; gabapentin; Diphenhydramine; morphine

Summary:

      Human experimental pain models are useful in understanding the mechanisms underlying clinical
      pain conditions and can be used to test the analgesic efficacy of drugs used in the
      management of pain. Once established these models can be used as mechanism biomarkers in
      early development clinical studies to establish proof of mechanism for novel compounds. The
      cold pain model is a mechanistic pain biomarker with potential application in proof of
      mechanism studies. In this study we aim to set up this cold pain model at a Clinical Research
      Unit and demonstrate we can effectively screen subjects for this model and examine the effect
      of morphine, diphenhydramine, and gabapentin in the cold pain model.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male volunteers having given consent to participate in the study who have no
             clinically significant anomalies and whose vital signs are within normal range.

          -  Subject having performed the cold pain test reproducibly ie, if the area under the
             pain-time curve (AUC) must be within 20% during successive tests within one cold pain
             test screening visit and within 30% between the two cold pain test screening visits.

        Exclusion Criteria:

          -  Subject who have had a serious adverse reaction or significant hypersensitivity to any
             of the study drugs.

          -  Subjects with a history of or evidence of any neurological condition which could
             affect pain sensation.

          -  Subjects with an AUCcpt 0-120 sec in the cold pain test of <1000 in any of the
             screening tests (excluding familiarization).
A First In Patient, Study Of Investigational Drug PF-03446962 In Patients With Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Intervention: PF-03446962
Intervention description: To determine the maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of PF-03446962 administered in patients with advanced solid tumors.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Solid Tumors Transforming Growth Factor Beta Activin Receptor-like Kinase 1

Summary:

      The purpose of this study is to test the safety and effectiveness of PF-03446962 when given
      as a single agent. Tumors require new blood vessels to support their ability to grow and to
      spread (metastasize). New treatments aimed at preventing these blood vessels have the ability
      to improve the clinical management of cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced measurable or non-measurable solid tumors

          -  Adequate bone marrow function

          -  Adequate liver function

          -  Adequate renal function

          -  Be able and willing to comply with the study scheduled visits, treatment plans,
             laboratory tests and other procedures

        Exclusion Criteria:

          -  Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of
             first dose of study medication

          -  Active bleeding disorder, including gastrointestinal bleeding, as evidenced by
             hematemesis, hemoptysis or melena in the past 6 months

          -  Any of the following within the 12 months prior to starting study treatment:
             myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
             graft, congestive heart failure, cerebrovascular accident including transient ischemic
             attack, or pulmonary embolus; or any other active thromboembolic event

          -  QTc prolongation defined as QTc >450 msec

          -  Patients with known brain metastasis

          -  Patients with peritoneal carcinosis at risk of bleeding

          -  Major surgical procedure within 4 weeks of treatment

          -  Pregnancy or breastfeeding