bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic Study of AG200-15 Transdermal Patch to Three Anatomical Sites in Healthy Females
Condition: Healthy
Intervention: AG200-15
Intervention description: A transdermal contraceptive delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). . A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.
Intervention MeSH terms: Contraceptive Agents
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PK and safety; Pharmacokinetic profile (PK) and safety

Summary:

      This is a pharmacokinetics and safety study over 3 weekly applications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy women, ages 18-45 years

          -  Body mass index 18 - 32, and weight ≥ 110 lbs.

          -  Willing to use a non-hormonal method of contraception if of childbearing potential, Or
             have already undergone previous bilateral tubal ligation or hysterectomy

          -  Willing to refrain from use of alcohol and grapefruit juice from 48 hours prior to
             patch application until completion of each treatment period

          -  Willing to give informed consent to participate in study

          -  Hemoglobin within normal range.

        Exclusion Criteria:

          -  Known or suspected pregnancy

          -  A cervical cytology smear of Papanicolaou (Pap) class III or greater or a Bethesda
             System report of low grade squamous intraepithelial lesions (SIL) or greater

          -  Smoking

          -  Hypertension (blood pressure >140 mm Hg systolic and/or >90 mm Hg diastolic)

          -  Diabetes Mellitus

          -  History of headaches with focal neurological symptoms

          -  Current or history of clinically significant depression in the last year

          -  Acute or chronic hepatocellular disease with abnormal liver function

          -  History of or existing venous and arterial thrombotic and thromboembolic disorder,
             vascular disease, cerebral vascular, or coronary artery disease

          -  Chronic use of any medication that might interfere with the efficacy of hormone
             contraceptives (including barbiturates, bosentan, carbamazepine, felbamate,
             griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's Wort, topiramate, and HIV
             protease inhibitors), OR use of these medications within the past 3 months prior to
             screening visit
Lorlatinib Renal Impairment Study
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: Lorlatinib
Intervention description: Lorlatinib single oral dose
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 1, open-label, multi-center, single treatment study in subjects with normal
      renal function and varying degrees of renal impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subjects of non-childbearing potential

          -  Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)

          -  Evidence of a personally signed and dated informed consent document indicating that
             the subject has been informed of all pertinent aspects of the study

          -  Subjects who are willing and able to comply with all scheduled visits, treatment plan,
             laboratory tests, and other study procedures.

          -  Demonstrate stable renal function

        Exclusion Criteria:

          -  Renal allograft recipients

          -  Any condition possibly affecting drug absorption (eg, gastrectomy)

          -  A positive urine drug test

          -  History of regular alcohol consumption exceeding 7 drinks/week for female subjects or
             14 drinks/week for male subjects (1 drink = 5 ounces [150 mL] of wine or 12 ounces
             [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before
             screening.

          -  Treatment with an investigational drug within 30 days (or as determined by the local
             requirement) or 5 half lives preceding the first dose of investigational product
             (whichever is longer).

          -  Screening supine triplicate 12 lead ECG demonstrating a corrected QT (QTc) interval
             >450 msec or a QRS interval >120 msec

          -  Second-degree or third-degree AV block (unless paced) or baseline PR interval >180
             msec at any time prior to dosing of study treatment.

          -  Abnormalities in clinical laboratory tests at screening

          -  Pregnant or breastfeeding female subjects

          -  History of HIV, Hepatitis B, Hepatitis C, HIT, sensitivity to heparin

          -  Other acute or chronic medical or psychiatric condition including recent (within the
             past year) or active suicidal ideation or behavior or laboratory abnormality that may
             increase the risk associated with study participation
Crizotinib Plus Pembrolizumab In Alk-Positive Advanced Non Small Cell Lung Cancer Patients
Condition: ALK-positive Advanced NSCLC
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Crizotinib; Pembrolizumab
Intervention description: To test 3 dose levels of crizotinib in combination with pembrolizumab 200 mg iv infusion every 3 weeks; To test pembrolizumab at 200 mg every 3 weeks in combination with crizotinib at 3 dose levels.
Intervention MeSH terms: Pembrolizumab; Crizotinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: crizotinib; pembrolizumab; ALK-positive NSCLC; Lung Cancer; ALK-translocated NSCLC; Non Small Cell Lung Cancer

Summary:

      The purpose of this study has 2 phases, a Dose Finding Phase will determine the maximum
      tolerated dose . The Dose Expansion Phase will explore the safety, tolerability, and
      anti-tumor activity of the combination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically proved diagnosis of locally advanced recurrent or
             metastatic non-squamous NSCLC that is not suitable for local curative treatment.

          -  Alk-positive NSCLC as determined by a test that is approved or validated for use as a
             companion diagnostic test.

          -  No prior systemic therapy for metastatic disease.

          -  Adjuvant chemotherapy more than 12 months prior to study enrollment.

          -  Measurable disease as per RECIST 1.1

          -  ECOG PS 0 or 1.

        Exclusion Criteria:

          -  Prior exposure to ALK receptor tyrosine kinase inhibitor, anti-PD1, anti-PDL1 or any
             drug targeting T-cell checkpoint pathways.

          -  known diagnosis of immunodeficiency or is receiving systemic steroid therapy or other
             form of immunosuppressive therapy within 7 days of clinical trial treatment.

          -  Active autoimmune disease that has required systemic treatment in the past 3 months.

          -  History of extensive disseminated interstitial fibrosis or any grade of interstitial
             lung disease.
Reinforcing Effects of Cocaine During Phendimetrazine Maintenance
Condition: Cocaine Use Disorder
Intervention: Phendimetrazine; Cocaine; Placebo
Intervention description: Phendimetrazine will be administered in divided doses twice daily.; Intranasal cocaine will be administered during experimental sessions.; Placebo capsules will contain only cornstarch.
Intervention MeSH terms: Cocaine; Phendimetrazine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will determine the initial efficacy of phendimetrazine as a pharmacotherapy for
      cocaine dependence. A rigorous, inpatient human laboratory study will be conducted in which
      the subjective, physiological and reinforcing effects of cocaine are evaluated during
      maintenance on placebo and phendimetrazine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recent cocaine use

        Exclusion Criteria:

          -  Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians
             deem clinically significant

          -  Current or past histories of substance abuse or dependence that are deemed by the
             study physicians to interfere with study completion

          -  History of serious physical disease, current physical disease, impaired cardiovascular
             functioning, chronic obstructive pulmonary disease, history of seizure or current or
             past histories of serious psychiatric disorder that in the opinion of the study
             physician would interfere with study participation will be excluded from participation

          -  Females not currently using effective birth control

          -  Contraindications to cocaine or phendimetrazine
Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis
Condition: Systemic Lupus Erythematosus; Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Lupus Erythematosus, Systemic
Intervention: PF-06835375; Placebo
Intervention description: Intravenous (IV) or subcutaneous (SC) administration. Subjects will receive one or two doses. Doses will be ascending and determined by emerging data.; Matching placebo for PF-06835375 IV or SC. Subjects will receive one or two doses.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This is a Phase 1 single and multiple dose escalation study to evaluate the safety,
      tolerability, pharmacokinetics, and pharmacodynamics of PF-06835375 in subjects with
      seropositive SLE or RA. The design is double-blind, sponsor open and placebo controlled. This
      study will include two parts: Part A and Part B. Part A will consist of single ascending dose
      cohorts, Part B of multiple ascending dose cohorts. This study will enroll up to a total of
      approximately 112 subjects at approximately 10 sites.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with Rheumatoid Arthritis: confirmed diagnosis according to 2010 ACR/EULAR
             criteria with symptom duration at least 6 months and positive with Rheumatoid Factor
             and/or anti citrullinated peptide antibody

          -  Patients with Systemic Lupus Erythematosus: Confirmed diagnosis according to the SLICC
             Classification Criteria with symptom duration at least 6 months and at least one of
             the following: positive antinuclear antibody titer, positive anti-dsDNA, anti-Smith
             antibodies

        Exclusion Criteria:

          -  Active central nervous system manifestations, systemic vasculitis or
             pleuro/pericarditis

          -  Active lupus nephritis

          -  Treatment with B cell depleting agents within 52 weeks prior to screening
A Study of Lasmiditan in Healthy Participants When Co-administered With Topiramate
Condition: Healthy
Intervention: Lasmiditan; Placebo; Topiramate
Intervention description: Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Topiramate; Lasmiditan
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will assess the safety, tolerability and blood concentrations of lasmiditan and
      topiramate together compared to lasmiditan and topiramate separately. Information about any
      side effects that may occur will be collected.

      Participants will be admitted to the Clinical Research Unit (CRU) one day prior to the start
      of the study and will remain through Day 14.

      This study is expected to last approximately 25 days, not including screening. Screening is
      required within 28 days prior to the start of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are healthy males or females (of non-child bearing potential), as determined by
             medical history and physical examination

          -  Have a body mass index of 19.0 to 35.0 kilograms per meter squared (kg/m²) inclusive

        Exclusion Criteria:

          -  Have known allergies to lasmiditan, topiramate, related compounds or any components of
             the formulation of lasmiditan or topiramate

          -  Have an abnormal supine blood pressure, defined as systolic blood pressure less than
             (<) 90 or great (>) 140 millimeters of mercury (mmHg) or diastolic blood pressure <60
             or >90 mmHg at screening

          -  Have known or ongoing psychiatric disorders considered clinically significant by the
             investigator or demonstrate suicidal ideation on the Columbia Suicide Severity Rating
             Scale (C-SSRS)

          -  Have a clinically significant abnormality in the neurological examination

          -  Have current or a history of orthostatic hypotension (>20-mmHg drop in systolic blood
             pressure, or >10-mmHg drop in diastolic blood pressure) with or without dizziness
             and/or syncope at screening or admission to the Clinical Research Unit (CRU) upon
             repeat testing

          -  Have an estimated glomerular filtration rate using Modification of Diet in Renal
             Disease <60 milliliter per minute (mL/min) per 1.73 meter squared (m²)

          -  Have a history of glaucoma

          -  Have a history of galactose intolerance, Lapp lactase deficiency, or glucose-galactose
             malabsorption
A Study of Abemaciclib in Participants With Cancer That is Advanced or Has Spread to Another Part(s) of the Body
Condition: Neoplasm Metastasis
MeSH terms: Neoplasm Metastasis
Intervention: Drug Cocktail; Abemaciclib
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Midazolam; Dextromethorphan; Caffeine; Warfarin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is known as a "drug interaction study" and is being done to see how abemaciclib
      may affect the blood levels of a drug mixture of commonly used drugs (caffeine, warfarin,
      dextromethorphan, and midazolam) when taken in combination with abemaciclib. Each participant
      will complete screening and four study periods in a fixed sequence, with the option to
      continue to receive abemaciclib in a safety extension phase. All participants will complete a
      safety follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histological or cytological evidence of a diagnosis of cancer that is advanced
             and/or metastatic

          -  Have adequate organ function

          -  Have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale

          -  Have discontinued all previous therapies for cancer (including chemotherapy,
             radiotherapy, immunotherapy, cancer-related hormone therapy, and investigational
             therapy) for at least 21 days for myelosuppressive agents or 14 days for
             nonmyelosuppressive agents prior to receiving study drug and have recovered from the
             acute effects of therapy(treatment related toxicity resolved to baseline), except for
             residual alopecia

        Exclusion Criteria:

          -  Require treatment with inducers or inhibitors of cytochrome P450 (CYP)1A2, CYP2C9,
             CYP2D6, and CYP3A within 14 days before the first dose of study drug through the end
             of Period 2

          -  History or presence of significant bleeding disorders

          -  Have known active uncontrolled or symptomatic CNS metastases

          -  Have a primary liver tumor

          -  Have lymphoma or leukemia
A Study of Lasmiditan (LY573144) in Children Aged 6 to 17 With Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Lasmiditan
Intervention description: Administered orally.
Intervention MeSH terms: Lasmiditan
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of the study is the measure the levels of lasmiditan in the body of children aged
      6 to 17 with migraine. The study also will also examine the safety and tolerability of
      lasmiditan in children aged 6 to 17 with migraine.

      The study will last about 6 weeks, and includes 4 visits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have a history of migraine headaches for more than 6 months

          -  Participants must have a history of 2 to 15 migraine headaches per month in the past 2
             months

          -  Participants must weigh between 15 and 55 kilograms (kg)

          -  Participants must not have a migraine headache on the day of lasmiditan administration

        Exclusion Criteria:

          -  Participants must not be pregnant or nursing

          -  Participants must not have any acute, serious, or unstable medical condition

               -  Participants must not be actively suicidal or at significant risk for suicide, in
                  the opinion of the investigator

          -  Participants must not be on a medicine that acts in the brain and spinal cord
A Study to Evaluate the Effect of Hepatic Impairment on the Single Dose Pharmacokinetics (PK) of Intravenous TAK-954
Condition: Hepatic Impairment; Healthy Volunteers
MeSH terms: Liver Diseases
Intervention: TAK-954
Intervention description: TAK-954 intravenous infusion.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to evaluate the effect of varying degrees of hepatic function on
      the single dose PK of IV TAK-954.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female participants (non-childbearing potential), with a body mass index
             (BMI) between 18 to 35 kilogram per square meter (kg/m^2) (All participants).

          2. Participants with hepatic impairment who are medically stable as determined by the
             investigator, based on medical history and clinical evaluations including physical
             examinations, clinical laboratory tests, vital sign measurements, and 12-lead ECGs
             performed at the Screening Visit and at check-in on Day -1 (Group 1 to 3).

          3. Healthy participants (Group 4).

        Exclusion Criteria:

        Participants who have:

          1. A history of hepatic carcinoma, hepatorenal syndrome, or presence of a liver mass by
             ultrasound, CT or MRI, or acute liver disease caused by an infection or drug toxicity
             (Group 1 to 3).

          2. Have severe hepatic encephalopathy ([greater than] > Grade II Portal Systemic
             Encephalopathy Score) (Group 1 to 3).

          3. Surgical porto-systemic shunts, including transjugular intrahepatic portosystemic
             shunt (Group 1 to 3).

          4. A history of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers
             less than 1 month prior to trial entry (Group 1 to 3).

          5. Bilirubin levels above 5 times the upper limit of normal (ULN) at screening or Day -1
             for Groups 1 and 2, there is no limit for Group 3.

          6. Severe/advanced ascites and/or pleural effusion which requires emptying and albumin
             supplementation, as judged by the investigator (Group 1 to 3).

          7. Renal creatinine clearance (CLcr) less than or equal to (<=) 50 milliliter per minute
             (mL/min), calculated using the Cockcroft-Gault equation from the serum creatinine
             measurement taken at screening (Group 1 to 3).

          8. Who have a history of clinically significant endocrine, gastrointestinal (GI)
             (including motility disorder and intestinal obstruction), cardiovascular,
             hematological, hepatic, immunological, renal, respiratory, genitourinary, or major
             neurological (including stroke and chronic seizures) abnormalities or diseases will be
             excluded from the trial (Group 4).