bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Coadministration of Sotorasib on the Pharmacokinetics of Rosuvastatin in Healthy Participants
Condition: Healthy Participants
Intervention: Rosuvastatin; Sotorasib
Intervention description: Oral dose; Oral dose
Intervention MeSH terms: Sotorasib; Rosuvastatin Calcium
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: AMG 510; Sotorasib; Rosuvastatin; Healthy participants

Summary:

      A study to determine the effect of sotorasib on the pharmacokinetics (PK) of rosuvastatin,
      and to assess the PK of rosuvastatin when administered alone, in healthy participants.
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy male subjects or female subjects, between 18 and 60 years of age (inclusive),
             at the time of Screening.

          -  Body mass index, between 18 and 30 kg/m2 (inclusive), at the time of Screening.

          -  Females of nonchildbearing potential

        Exclusion criteria:

          -  Inability to swallow oral medication or history of malabsorption syndrome.

          -  History of hypersensitivity, intolerance, or allergy to any drug compound, food, or
             other substance, unless approved by the Investigator (or designee) and in consultation
             with the Sponsor.

          -  Poor peripheral venous access.

          -  History or evidence, at Screening or Check in, of clinically significant disorder,
             condition, or disease, including history of myolysis, not otherwise excluded that, in
             the opinion of the Investigator (or designee), would pose a risk to subject safety or
             interfere with the study evaluation, procedures, or completion.
A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: LY3819253; Placebo
Intervention description: Administered IV.; Administered IV.
Intervention MeSH terms: Bamlanivimab
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test the safety and tolerability of LY3819253 when it is
      given by injection into a vein to participants hospitalized with COVID-19. Blood tests will
      be done to check how much LY3819253 is in the bloodstream and how long the body takes to
      eliminate it. Participation could last about 8 weeks and may include up to 15 visits in the
      hospital or the home.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are hospitalized or in the process of being admitted to hospital and have an initial
             laboratory determination of current COVID-19 infection less than or equal to (≤)72
             hours prior to randomization

          -  Are men or non-pregnant women

          -  Women of childbearing potential must agree to use at least one highly effective form
             of contraception for the entirety of the study

          -  Agree to the collection of nasopharyngeal swabs and venous blood

        Exclusion Criteria:

          -  Require mechanical ventilation or anticipated impending need for mechanical
             ventilation

          -  Received convalescent COVID-19 plasma treatment prior to enrollment

          -  Were resident in a nursing home or long-term care facility immediately prior to
             current hospitalization

          -  Suspected or proven serious, active bacterial, fungal, viral, or other infection
             (besides COVID-19) that in the opinion of the investigator could constitute a risk
             when taking investigational product

          -  Have an oxygen saturation (SpO2) less than (<)88 percent (%) while breathing room air
             at rest at randomization.
A Study of Mirikizumab in Participants With Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Drug Cocktail; Mirikizumab
Intervention description: Drug cocktail consists of caffeine, warfarin plus vitamin K, omeprazole, dextromethorphan, and midazolam, administered orally; Administered SC
Intervention MeSH terms: Mirikizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is known as a "drug interaction study." The purpose is to learn how commonly used
      drugs or substances (midazolam, warfarin, dextromethorphan, omeprazole, and caffeine) and
      their breakdown products get into the bloodstream after taking a "cocktail" (combination) of
      them before and after multiple doses of mirikizumab.

      The study will last about 23 weeks for each participant. Screening must be completed within 4
      weeks prior to study start.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females with chronic plaque psoriasis for at least 6 months who are
             candidates for systemic therapy or phototherapy

          -  Have greater than or equal to (≥) 10 percent body surface area (BSA) involvement at
             screening and first admission to the clinical site

        Exclusion Criteria:

          -  Pregnant or nursing (lactating)

          -  History of an ongoing, chronic or recurrent infectious disease, or evidence of
             tuberculosis infection

          -  Have major surgery within 8 weeks prior to first admission to the clinical site or
             during the study

          -  Have a history of lymphoma, leukemia, or any malignancy

          -  Require treatment with the cocktail drugs within 14 days prior to the first
             administration of the drug cocktail through the end of Week 12 assessments

          -  Have participated in any other study with mirikizumab
Evaluation of MK-1075 in Participants With Hepatitis C Virus (HCV) Infection (MK-1075-002)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: MK-1075
Intervention description: MK-1075 supplied as 10 mg or 100 mg tablets for oral administration.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: In each panel (A, B, C, and D), participants will receive a single dose of MK-1075 (100, 200, 400, and 800 mg, respectively) in a fasted state. Safety and viral load (VL) data from the previous panel will be assessed before dosing the subsequent panel.
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and pharmacokinetics of MK-1075, and to
      determine the ability of MK-1075 to reduce HCV viral load, following administration of a
      single dose in HCV-infected participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female of non-child bearing potential

          -  In good health other than HCV genotype (GT) 1 infection

        Exclusion Criteria:

          -  Is mentally incapacitated or legally institutionalized

          -  Has a history of clinically significant and not stably controlled endocrine,
             gastrointestinal, cardiovascular, hematological, hepatic (excepting HCV infection),
             immunological, renal, respiratory, genitourinary or major neurological (including
             stroke and chronic seizures) abnormalities or diseases

          -  Has a history of cancer

          -  Is positive for hepatitis B surface antigen (HBsAg) or human immunodeficiency virus
             (HIV)

          -  Has participated in another investigational trial within 4 weeks (or 5 half-lives)
             prior to Screening

          -  Consumes >2 alcoholic beverages a day or uses illegal drugs

          -  Has evidence or history of chronic hepatitis not caused by HCV including but not
             limited to non-HCV viral hepatitis, non-alcoholic steatohepatitis (NASH), drug-induced
             hepatitis, or autoimmune hepatitis

          -  Has clinical or laboratory evidence of advanced or decompensated liver disease,
             evidence of bridging fibrosis or higher grade fibrosis (Metavir score ≥3) from prior
             liver biopsy
Monoclonal Antibody Therapy in Treating Patients With Progressive Small Cell Lung Cancer (SCLC)
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: monoclonal antibody hu3S193
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent small cell lung cancer (SCLC)

Summary:

      RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver
      tumor-killing substances to them without harming normal cells.

      PURPOSE: This phase I trial is studying the side effects of monoclonal antibody therapy in
      treating patients with progressive small cell lung cancer (SCLC).
    

Eligibility criteria:

        Inclusion Criteria:

        Small cell lung cancer, pathologically confirmed. Measurable disease, including at least
        one lesion measuring ≥ 2 cm that has not been previously irradiated.

        Progression of disease after one, two, or three prior chemotherapy regimens. At least 4
        weeks since the last chemotherapy or radiation treatment. Karnofsky performance status ≥
        70% (ECOG 0 or 1).

        The following laboratory results within the last 2 weeks prior to study day 1:

        White Blood Cell Count (WBC) ≥ 3,500/mm3; Platelet count ≥ 100 x 10^9/L; Serum creatinine ≤
        2.0 mg/dL; Serum bilirubin ≤ 2.0 mg/dL; International normalized ratio (INR) ≤ 1.3; Women
        of childbearing potential with confirmed negative quantitative serum HCG on the day of
        administration of study agent.

        Negative stool guaiac test (read by laboratory). Tumor tissue positive for Lewis Y
        expression.

        Exclusion Criteria:

        Clinically significant cardiac disease (New York Heart Association Class III/IV).

        Uncontrolled brain or leptomeningeal metastases. GI bleed within the preceding 6 months.
        Patients with history of receiving mouse monoclonal antibody. Participation in any other
        clinical trial involving another investigational agent within 4 weeks prior to enrollment.

        Women who are pregnant or breast-feeding.
Effect of Copanlisib on Metformin Pharmacokinetics and Pharmacodynamics
Condition: Healthy Volunteers
Intervention: Copanlisib (Aliqopa, BAY80-6946); Metformin
Intervention description: The copanlisib dose for this study is the standard dose recently approved and also used in Phase 1, 2 and 3 studies across the copanlisib development program: 60 mg i.v. infusion administered intermittently on Days 1, 8 and 15 of a 28-day cycle.
In this study subjects will receive a single i.v. dose of 60 mg copanlisib on day 8.; Single dose of 1000 mg is administered orally.
Intervention MeSH terms: Metformin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to learn about a drug-drug interaction. When two medications are
      taken together at the same time, one medication may change the activity of the other
      medication in the body - this is called a drug-drug interaction. This study is looking at the
      effect the Bayer study drug, copanlisib, has on metformin, a commonly used medication to
      treat diabetes. During the study, blood and urine samples will be collected and analyzed to
      learn about pharmacokinetics (how copanlisib changes metformin levels in the body) and
      pharmacodynamics (the effect metformin has on the body when taken together with copanlisib)
      when someone takes both copanlisib and metformin together.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or female subjects - as determined by the investigator or medically
             qualified designee based on medical evaluations, including medical history, physical
             examination, laboratory tests and cardiac monitoring

          -  Aged 18 to 45 years at the first screening visit

          -  Body Mass Index (BMI) of 18.0 - 34 kg / m*2 , with body weight ≥ 50 kg

          -  Creatinine clearance ≥ 90 mL/min using the Modification of Diet in Renal Disease

          -  Adequate end organ and bone marrow function

        Exclusion Criteria:

          -  Existing relevant diseases of vital organs (e.g. liver diseases, heart diseases),
             central nervous system (for example seizures) or other organs (e.g. diabetes mellitus)

          -  Incompletely cured pre-existing diseases for which it can be assumed that the
             absorption, distribution, metabolism, elimination and effects of the study drugs will
             not be normal

          -  Relevant respiratory insufficiency / disorder

          -  Administration of strong CYP3A4 inhibitors or inducers within 2 weeks prior to dosing

          -  Known history of hypersensitivity (or known allergic reaction) to copanlisib,
             metformin, related compounds, or any components of the formulation
Relative Bioavailability of Two Different Capsule Formulations of Sitravatinib in Healthy Adults
Condition: Tumor
Intervention: Sitravatinib; Sitravatinib
Intervention description: Administered orally as a free base capsule; Administered orally as a malate salt capsule
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of the study was to investigate the relative bioavailability and
      pharmacokinetics (PK) of sitravatinib free base and malate salt capsule formulations
      following oral administration in healthy adults.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Body mass index between 18.0 and 32.0 kg/m2, inclusive.

          2. In good health, determined by no clinically significant findings from medical history,
             physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory
             evaluations at Screening and/or Check-in as assessed by the Investigator (or
             designee).

          3. Able to swallow multiple capsules.

        Key Exclusion Criteria:

          1. History of stomach or intestinal surgery or resection

          2. Have previously completed or withdrawn from this study or any other study
             investigating sitravatinib and have previously received the investigational product.

          3. Participants who, in the opinion of the Investigator (or designee), should not
             participate in this study.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Interaction of Bexagliflozin With Metformin, Glimepiride and Sitagliptin
Condition: Type2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Bexagliflozin; Metformin; Glimepiride; Sitagliptin
Intervention description: Bexagliflozin tablets, 20 mg; 1000 mg metformin; 4 mg glimepiride; 100 mg sitagliptin
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Glimepiride; Bexagliflozin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to examine the drug-drug interaction in your body when given the
      study drug, bexagliflozin, with three commonly used ant-diabetic medications, metformin,
      glimepiride or sitagliptin. The study will also evaluate how safe the study drug is and how
      well the study drug is tolerated when taken with metformin, glimepiride or sitagliptin.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects with body-mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2

          2. Subjects who are non-smokers for at least 3 months prior to screening

          3. Subjects who are willing and able to be confined to the clinical research facility as
             required by the protocol

        Exclusion Criteria:

          1. Subjects with a clinically significant history of allergy to drugs or latex.

          2. Subjects with a history of alcohol or drug dependence in the past 12 months.

          3. Subjects who have donated a significant amount of blood in the past 2 months

          4. Female subjects who are pregnant or breastfeeding

          5. Subjects who are not willing to use an adequate form of birth control during the study
             and for 30 days after discharge from clinic

          6. Subjects who have taken an investigational drug in the past 30 days or 7 half-lives of
             the investigational drug, whichever is longer

          7. Subjects who had previously received anti-diabetic medication, including metformin,
             sitagliptin, glimepiride or drugs of the same class (i.e. biguanides, DPP-4 inhibitors
             or sulfonylureas), or SGLT2 inhibitors, in the past 3 months
A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers
Condition: Healthy Volunteers
Intervention: Omeprazole; Sotorasib
Intervention description: Omeprazole will be administered as an oral capsule.; Sotorasib will be administered as an oral tablet.
Intervention MeSH terms: Sotorasib; Omeprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy volunteers; Sotorasib; AMG 510; Omeprazole

Summary:

      The primary objective of the study is to evaluate the effects of omeprazole (a proton-pump
      inhibitor) and an acidic beverage (Coca-Cola) on sotorasib pharmacokinetics (PK) when
      administered orally in healthy volunteers.
    

Eligibility criteria:

        Inclusion:

          -  Healthy male participants or female participants, between 18 and 60 years of age
             (inclusive), at the time of Screening.

          -  Body mass index, between 18 and 30 kg/m^2 (inclusive), at the time of Screening.

          -  Females of nonchildbearing potential.

        Exclusion:

          -  Inability to swallow oral medication or history of malabsorption syndrome.

          -  History of hypersensitivity, intolerance, or allergy to any drug compound, food, or
             other substance, unless approved by the Investigator (or designee) and in consultation
             with the Sponsor.

          -  Poor peripheral venous access.

          -  History or evidence, at Screening or Check in, of clinically significant disorder,
             condition, or disease, including history of myolysis, not otherwise excluded that, in
             the opinion of the Investigator (or designee), would pose a risk to participant safety
             or interfere with the study evaluation, procedures, or completion.
Safety And Tolerability Study Of RN6G In Subjects With Advanced Dry, Age-Related Macular Degeneration Including Geographic Atrophy
Condition: Age-Related Maculopathy; Age-Related Maculopathies; Eye Diseases; Retinal Degeneration; Macular Degeneration
MeSH terms: Macular Degeneration; Eye Diseases; Geographic Atrophy; Retinal Degeneration; Atrophy
Intervention: RN6G; Placebo
Intervention description: Intravenous, multiple dose, dose ranging from 5 mg/kg up to a maximum of 15 mg/kg; Intravenous, multiple dose with experimental dose
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 60 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Phase 1b Advanced Dry Age-Related Macular Degeneration RN6G

Summary:

      The purpose of this study is to determine the safety and tolerability of multiple doses of
      RN6G in subjects with advanced dry, age-related macular degeneration including geographic
      atrophy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be of non-child bearing potential

          -  Diagnosis of dry AMD including uni- or multi-focal geographic atrophy without foveal
             involvement

          -  BCVA of 20/50 or better in the study eye

        Exclusion Criteria:

          -  Evidence of ocular disease other than advanced AMD or GA in the study eye

          -  History or diagnosis of exudative (wet) AMD, with subretinal or choroidal neovascular
             lesions in the study eye

          -  Presence of disease or condition that might compromise the cardiovascular,
             hematological, renal, hepatic, pulmonary, endocrine, central nervous immune, or
             gastrointestinal system

          -  Requires ocular or systemic medications that are known to be toxic to the lens, retina
             or optic nerve