bioihbjkbjnl/mcl2 huggingface dataset:
Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Sitagliptin phosphate/metformin hydrochloride FDC; Sitagliptin phosphate; Metformin hydrochloride
Intervention description: Single dose sitagliptin/metformin 50/500 mg FDC tablet after consumption of a high-fat meal in one of two treatment periods.; Single dose sitagliptin 50 mg tablet after consumption of a high-fat meal in one of two treatment periods.; Single dose metformin 500 mg tablet after consumption of a high-fat meal in one of two treatment periods.
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will demonstrate the bioequivalence of metformin after single dose administration
      of sitagliptin/metformin 50/500 mg fixed dose combination (FDC) tablet and concomitant
      administration of single doses of sitagliptin 50 mg and metformin 500 mg as individual
      tablets after consumption of a high-fat meal.
    

Eligibility criteria:

        Inclusion Criteria:

          -  is in good health

          -  is a nonsmoker

          -  is willing to follow all study guidelines

        Exclusion Criteria:

          -  has or has a history of any illness or condition that might confound the results of
             the study or make participation unsafe for the participant

          -  is a nursing mother

          -  is unwilling to consume the required high-fat breakfast
First in Patient Study for PF-06840003 in Malignant Gliomas
Condition: Oligodendroglioma; Astrocytoma; Malignant Glioma
MeSH terms: Glioma; Astrocytoma; Oligodendroglioma
Intervention: PF-06840003
Intervention description: Daily Oral PF-06840003
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: GBM; malignant glioma; glioma; anaplastic glioma; astrocytoma; IDO; IDO1; PF-06840003

Summary:

      This study will evaluate the safety and tolerability of increasing doses of PF-06840003 in
      patients with malignant gliomas.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of WHO Grade IV glioblastoma or WHO Grade III anaplastic gliomas

          -  For patients with Grade IV GBM, recurrent disease at the time of the first or second
             recurrence or progression. For patients with Grade III anaplastic gliomas, recurrent
             disease at the time of at least a first recurrence but no more than a fourth
             recurrence or progression

          -  Karnofsky performance score greater than or equal to 70%

          -  Adequate bone marrow, kidney and liver function

        Exclusion Criteria:

          -  History of CNS bleeding within 6 months of registration

          -  Previous anti-angiogenics or anti-vascular endothelial growth factor within 12 months
             of registration

          -  Requires treatment with high dose systemic corticosteroids defined as >2 mg/day

          -  Radiation therapy within 12 weeks of registration
A Drug-Drug Interaction Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Apremilast
Condition: Healthy Subjects
Intervention: Apremilast; Rifampin Oral Capsules; Rifampin IV Solution
Intervention description: Tablets for oral administration; Capsules for oral administration; Intravenous (IV) solution
Intervention MeSH terms: Rifampin; Apremilast
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Apremilast; drug interaction; pharmacokinetics

Summary:

      The purpose of this study is to evaluate how the pharmacokinetics of apremilast may be
      affected by a single intravenous dose of rifampin and multiple oral doses of rifampin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or female subjects of any ethnic origin between ages of 18 and 55 with a
             body mass index between 18 and 33

        Exclusion Criteria:

          -  Recent history (i.e., within 3 years) of any clinically significant neurological,
             gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, endocrine,
             hematological, dermatological, psychological, allergic or other major disorders.

          -  Use of any prescribed or non-prescribed systemic or topical medication (including
             vitamins and herbal medicines, e.g. St. John's Wort) within 30 days of the first dose,
             unless an exception is granted by the sponsor.

          -  Presence of any surgical or medical conditions possibly affecting drug absorption,
             distribution, metabolism, and excretion, or plans to have elective or medical
             procedures during the conduct of the trial.

          -  Exposure to an investigational drug (new chemical entity) within 30 days prior to the
             first dose administration
Study To Evaluate The Effect Of Two Steady State Doses of PF 06882961 On Rosuvastatin And Midazolam Pharmacokinetics In Otherwise Healthy Adult Participants With Obesity
Condition: Obesity
MeSH terms: Obesity
Intervention: PF-06882961; Rosuvastatin; Midazolam
Intervention description: 120 mg and 200 mg BID; 10 mg single dose; 2mg single dose
Intervention MeSH terms: Midazolam; Rosuvastatin Calcium
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Crossover Assignment
Intervention model description: Crossover
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: obesity

Summary:

      A Phase 1 Study To Evaluate The Effect Of Two Steady State Doses of PF 06882961 On
      Rosuvastatin And Midazolam Pharmacokinetics In Otherwise Healthy Adult Participants With
      Obesity
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body Mass Index (BMI) ≥ 30.0 kg/m2 and not more than 45.4 kg/m2 at Screening.

          -  Stable body weight, defined as <5 kg change (per participant report) for 90 days
             before Screening

        Exclusion Criteria:

          -  Known prior participation in a trial involving PF-06882961.

          -  Known intolerance or hypersensitivity to GLP-1R agonists.

          -  Known hypersensitivity to rosuvastatin or midazolam.

          -  Diagnosis of type 1 or type 2 diabetes mellitus or secondary forms of diabetes at
             screening. Note: prior diagnoses of gestational diabetes during pregnancy only are
             eligible if they meet the other eligibility criteria

          -  Any lifetime history of a suicide attempt.

          -  Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
             within 60 days prior to dosing.

          -  Participation in a formal weight reduction program (eg, Weight Watchers) within 90
             days prior to Screening.
Effect of Denosumab on Cellular Biomarkers in the Human Breast
Condition: Healthy Volunteer, Female, Breast
Intervention: Denosumab; Percutaneous core needle breast biopsy
Intervention description: Single sucutaneous dose
Intervention MeSH terms: Denosumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 82.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To evaluate whether administration of denosumab results in a decrease compared to the control
      group in proliferation of mammary epithelial cells as measured by the Ki-67 proliferation
      index.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Willing to use, in combination with her partner, 2 non-hormonal methods of effective
             contraception or practice sexual abstinence. Subjects who are surgically sterile (eg,
             history of hysterectomy) or whose sexual partner is sterile (eg, history of vasectomy)
             are not required to use contraceptive measures

          -  Laboratory tests are within clinically acceptable range

          -  Clinically acceptable physical exam and no history or evidence of any clinically
             significant medical disorder that would pose a risk to subject safety or interfere
             with study evaluations or procedures.

        EXCLUSION CRITERIA:

          -  Female subject with a prior history of breast cancer; breast implant in the breast to
             be biopsied; Known history of fibrocystic breast disease

          -  Subject is unable or unwilling to provide breast biopsy tissue from the upper outer
             quadrant of her breast

          -  Pregnant or plans to become pregnant while exposed to investigational product

          -  Lactating/breastfeeding or plans to breastfeed while exposed to investigational
             product

          -  Recent use of any non-approved medications or devices

          -  Uncontrolled thyroid disorder

          -  Significant dental/oral disease

          -  Planned invasive dental procedures

          -  Positive urine screen for alcohol and/or drugs
An Open-Label, Single Dose Safety Study of Quadrivalent HPV Vaccine in Chinese Female Subjects (V501-035)
Condition: HPV Infections
MeSH terms: Papillomavirus Infections
Intervention: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Intervention description: HPV 6,11,16,18 VLP, 0.5 mL 1 dose injection.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: Female
Minimum age: 9 Years
Maximum age: 26 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To prove that quadrivalent HPV (types 6, 11, 16, 18) L1 virus-like particle (VLP) vaccine is
      generally safe and well tolerated in the Chinese population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject Is Female, Between The Ages Of 9 Years And 0 Days And 26 Years And 364 Days On
             The Day Of Enrollment

          -  Subject (Or, For Minor Subjects, Parent/Legal Guardian And Subject) Fully Understands
             Study Procedures, Alternative Treatments Available, The Risks Involved With The Study,
             And Voluntarily Agrees To Participate By Giving Written Informed Consent

          -  Subject Is Able To Read, Understand, And Complete The Vaccination Report Card

        Exclusion Criteria:

          -  Subject Is, At The Time Of Signing Informed Consent, A User Of Recreational Or Illicit
             Drugs Or Has Had A Recent History (Within The Last Year) Of Drug Or Alcohol Abuse Or
             Dependence. Alcohol Abusers Are Defined As Those Who Drink Despite Recurrent Social,
             Interpersonal, And/Or Legal Problems As A Result Of Alcohol Use

          -  Subject Has A History Of Severe Allergic Reaction (E.G., Swelling Of The Mouth And
             Throat, Difficulty Breathing, Hypotension Or Shock) That Required Medical Intervention

          -  Subject Has Known Allergy To Any Vaccine Component, Including Aluminum, Yeast, Or
             Benzonase (Nuclease, Nycomed [Used To Remove Residual Nucleic Acids From This And
             Other Vaccines])
A Pilot Study of Moderate Hyperbilirubinemia in Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hyperbilirubinemia
Intervention: Atazanavir
Intervention description: The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug.
Intervention MeSH terms: Atazanavir Sulfate
Phase: Phase 1
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Specific Aim: To establish the feasibility of studying the change in endothelial function
      caused by induced moderate hyperbilirubinemia in type 1 diabetes. Atazanavir, a drug that
      inhibits bilirubin conjugation, will be used to induce moderate hyperbilirubinemia.
      Endothelial function will be measured before and after atazanavir therapy. In addition,
      plasma markers of antioxidant capacity and oxidant stress will be measured as
      proof-of-concept that induced moderate hyperbilirubinemia has favorable effects on oxidative
      stress in type 1 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Symptoms of diabetes plus casual plasma glucose concentration ≥ 200 mg/dl (11.1
             mmol/l), or;

          2. FPG ≥ 126 mg/dl (7.0 mmol/l), or;

          3. 2-h postload glucose ≥ 200 mg/dl (11.1 mmol/l) during an OGTT. In addition, subjects
             would be required to be at increased risk of cardiovascular events, defined as:

               -  microalbuminuria, or;

               -  T1DM duration of > 20 years.

        Exclusion Criteria:

          1. HIV infection

          2. Gilbert's syndrome

          3. Hepatic failure or active hepatitis,

          4. Unstable cardiovascular disease, including angina, heart failure or arrhythmia

          5. drug abuse including alcoholism or addiction to cocaine, heroin or amphetamines

          6. Use of medications that significantly with atazanavir

          7. Pregnancy, or inability to practice adequate contraception
Ph1 Marinol Interaction Study - Part 2 - 1
Condition: Marijuana Dependence
MeSH terms: Marijuana Abuse
Intervention: Placebo; Dronabinol
Intervention MeSH terms: Dronabinol
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Marijuana dependence

Summary:

      This study will examine the effects of oral dronabinol tetrahydrocannabinol (THC) on
      withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety,
      pharmacokinetics (PK), and cardiovascular effects of the combination of oral dronabinol and
      smoked marijuana to determine if there are potential significant drug interactions before
      conducting outpatient studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be between 18 and 45 years of age

          -  Must be in good general health and who meet DSM-IV diagnostic criteria for marijuana
             dependence

          -  Must be seeking treatment at time of study entry

          -  Must be able to understand and provide written informed consent

          -  Must provide 1 marijuana positive urine specimen (> 50 ng/mL) within the 28-day
             screening period

          -  If female and of child bearing potential, agrees to use birth control.

        Exclusion

        Criteria:

          -  Please contact site for more information
A Study of Treprostinil and a New Formulation of LY900014 in Healthy Japanese Participants
Condition: Healthy
Intervention: Treprostinil; Placebo; LY900014; Insulin Lispro
Intervention description: Administered SC.; Administered SC.; Administered SC.; Administered SC.
Intervention MeSH terms: Insulin Lispro; Treprostinil
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The aims of this study are to evaluate:

        -  The safety and tolerability of a single dose of treprostinil given subcutaneously (as an
           injection just under the skin)

        -  The pharmacokinetic profile (how the body absorbs, breaks down, and gets rid of) of a
           single subcutaneous dose of a new LY900014 formulation in healthy Japanese participants.

      The study has two parts. Participants may only enroll in one part.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy Japanese

          -  Body mass index (BMI) 18.5 - 25 kilograms per square meter (kg/m²)

          -  Fasting plasma glucose ≥71 milligrams per deciliter (mg/dL) (3.9 millimoles per liter
             [mmol/L]) and <108 mg/dL (6.0 mmol/L) (Part B only)

          -  Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine
             laboratory test results that are acceptable for the study

        Exclusion Criteria:

          -  Are currently enrolled in a clinical trial involving an investigational product or any
             other type of medical research judged not to be scientifically or medically compatible
             with this study

          -  Have participated in a clinical trial involving an investigational product within the
             30 days before study entry.

          -  Have previously completed or withdrawn from this study or any other study
             investigating treprostinil or LY900014, and have previously received the
             investigational product

          -  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
Relative Bioavailability of Pimasertib in Cancer Patients
Condition: Neoplasms
MeSH terms: Neoplasms
Intervention: Pimasertib Capsule (Part A); Pimasertib Tablet (Part A); Pimasertib Tablet (Part A); Pimasertib Capsule (Part A); Pimasertib Capsule (Part B and trial extension phase)
Intervention description: Pimasertib capsule administration at a single dose of 60 milligram (mg) orally on Day 1 in Part A.; Pimasertib tablet administration at a single dose of 60 mg orally on Day 3 in Part A.; Pimasertib tablet administration at a single dose of 60 mg orally on Day 1 in Part A.; Pimasertib capsule administration at a single dose of 60 mg orally on Day 3 in Part A.; Subjects completing Part A to receive pimasertib capsule at a dose of 60 mg orally twice daily in cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
Intervention MeSH terms: Niacinamide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Neoplasms; Pimasertib; Cancer

Summary:

      This is a Phase 1, multi-center, open-label, single-dose, 2 period, 2 sequence cross-over
      trial to investigate the relative bioavailability of 2 solid oral pimasertib formulations in
      cancer subjects (Part A), followed by open-label pimasertib administration (Part B and trial
      extension phase).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically confirmed solid tumors, either refractory to standard therapy or for
             which no effective standard therapy is available, with a measurable disease as defined
             by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

          -  An Eastern Cooperative Oncology Group Performance Status (ECOG PS) of less than or
             equal to (<=) 1

          -  Other protocol defined inclusion criteria could apply

        Exclusion Criteria:

          -  Disease conditions or concomitant medication that may significantly influence the
             conduct of the trial or an abnormal electrocardiogram (ECG) or blood pressure at
             Screening as defined in the protocol

          -  Treatment with strong inhibitors or inducers of cytochrome P450 2C19 (CYP2C19) and
             CYP3A4 including fruit juices or beverages containing these substances

          -  History of prior mitogen-activated protein kinase/extracellular signal-regulated
             kinase (MAPK/ERK) kinase (MEK) inhibitor exposure (including, pimasertib) or
             progression of disease on MEK inhibitors

          -  Evidence of a retinal vein occlusion (RVO) on fluorescein angiogram or a history of
             RVO

          -  Life expectancy of less than 12 weeks

          -  Other protocol defined exclusion criteria could apply
DDI Between BI Empagliflozin (10773) and Verapamil
Condition: Healthy
Intervention: Verapamil; BI 10773; BI 10773
Intervention description: single dose verapamil; single dose BI 10773; single dose BI 10773
Intervention MeSH terms: Empagliflozin; Verapamil
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Relative bioavailability of BI 10773 given alone and together with verapamil
    

Eligibility criteria:

        Inclusion criteria:

        healthy male and female subjects

        Exclusion criteria:

        Any relevant deviation from healthy conditions