bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: TRK-250; Placebo
Intervention description: single and multiple doses (4 weeks); single and multiple doses (4 weeks)
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: TRK-250; Idiopathic Pulmonary Fibrosis

Summary:

      TRK-250 is a nucleic acid medicine that inhibits the progression of pulmonary fibrosis by
      selectively suppressing the expression of transforming growth factor-beta 1 (TGF-β1) protein,
      at the gene expression level. This study is a double-blind, randomized, placebo-controlled
      Phase I study. The primary objective of the study is to assess the safety and tolerability of
      single and multiple inhaled doses of TRK-250 in subjects with idiopathic pulmonary fibrosis
      (IPF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical, radiographic, and histologic features consistent with the diagnosis of IPF

          -  SpO2 ≥90% at rest by pulse oximetry while breathing ambient air.

          -  FVC ≥50% of predicted.

          -  FEV1 ≥50% of predicted.

          -  Ratio of FEV1 to FVC ≥0.7.

          -  DLCO corrected for hemoglobin 30% to 79% of predicted, inclusive.

        Exclusion Criteria:

          -  History of acute exacerbation of IPF or respiratory tract infection within 3 months
             prior to Screening.

          -  Planned surgery during the study.

          -  History of malignant tumor within 5 years prior to Screening.

          -  History of emphysema or clinically significant respiratory diseases (other than IPF).

          -  Other known causes of interstitial lung disease (eg, drug toxicities, environmental
             exposures, connective tissue diseases).

          -  End-stage fibrotic disease expected to require organ transplantation within 6 months.

          -  Taking a systemic corticosteroid, cytotoxic therapy, vasodilator therapy for pulmonary
             hypertension, or unapproved treatment for IPF within 4 weeks prior to Screening.
             (Treatment with pirfenidone or nintedanib, though not both concurrently, is permitted,
             provided that the subject has been on a stable dose for at least 4 weeks prior to
             Screening and it is anticipated the dose will remain unchanged throughout enrollment.)
PP100-01 (Calmangafodipir) for Overdose of Paracetamol
Condition: Paracetamol Overdose
MeSH terms: Drug Overdose
Intervention: PP100-01 (calmangafodipir); Acetylcysteine
Intervention description: PP100-01; NAC
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      Investigate the safety and tolerability of PP100-01 add-on treatment to the 12hr NAC
      treatment regime in patients treated for paracetamol/acetaminophen overdose (POD) when NAC
      treatment is initiated before 24hours post POD.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Any patient with capacity admitted to hospital within 24 hrs either a single acute POD
             or more than one dose of paracetamol (staggered) and deemed to require treatment with
             NAC.

          2. Provision of written informed consent

          3. Males and females of at least 16 years of age

        Exclusion Criteria:

          1. Patients that do not have the capacity to consent to participate in the study

          2. Patients detained under the Mental Health Act or deemed unfit by the Investigator to
             participate due to mental health.

          3. Patients with known permanent cognitive impairment

          4. Patients who are pregnant or nursing

          5. Patients who have previously participated in the study

          6. Unreliable history of POD

          7. Patients presenting after 24hrs of POD

          8. Patients who take anticoagulants (e.g. warfarin) therapeutically or have taken an
             overdose of anticoagulants

          9. Patients who, in the opinion of the responsible clinician/nurse, are unlikely to
             complete the full course of NAC e.g. expressing wish to self-discharge

         10. Prisoners

         11. Non-English speaking patients. (Study information material will only be produced in
             English in view of the known and stable demographic of the Edinburgh self-harm
             population).
Pharmacokinetics and Safety Study of BI 695502 in Healthy Subjects
Condition: Healthy
Intervention: BI 695502; bevacizumab; bevacizumab
Intervention description: BI 695502 single i.v. infusion; bevacizumab single i.v. infusion; bevacizumab single i.v. infusion
Intervention MeSH terms: Bevacizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Enrollment: 91.0
Sex: Male
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This trial will investigate the pharmacokinetics and safety of BI 695502 and to establish
      pharmacokinetic biosimilarity of BI 695502 compared to bevacizumab.
    

Eligibility criteria:

        Inclusion criteria:

          1. Healthy males.

          2. Complete medical history, including physical examination, vital signs, 12-lead
             electrocardiogram (ECG), and clinical laboratory tests.

          3. Aged 21 to 50 years.

          4. Body mass index below or equal to 30.

          5. Body weight 65 to 95 kg, inclusive.

        Exclusion criteria:

          1. Any finding of the medical examination (including blood pressure, pulse rate and ECG)
             deviating from normal and of clinical relevance.

          2. Any evidence of a clinically relevant concomitant disease, as judged by the
             investigator.

          3. History of relevant orthostatic hypotension, fainting spells, or blackouts.

          4. Chronic or relevant acute infections.

          5. History of relevant allergy/hypersensitivity (including allergy to the study
             medications or its excipients).

          6. Intake of prescribed or over-the-counter drugs within less than 6 half-lives of the
             respective drug prior to study drug administration or during the trial.

          7. Participation in another trial with a study medication within two months prior to
             administration or during the trial (six half-lives).

          8. Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day).

          9. Inability to refrain from smoking during days of confinement at the study center.

         10. Current alcohol abuse as judged by the investigator.

         11. Current drug abuse, as judged by the investigator.
Dose Escalation Study With MK-2206 in Patients With Locally Advanced or Metastatic Solid Tumors (MK-2206-002)
Condition: Locally Advanced Tumors; Metastatic Solid Tumors; Cancer; Neoplasms
MeSH terms: Neoplasms
Intervention: MK-2206
Intervention description: MK-2206 administered as an oral formulation in rising dose levels on a QOD schedule (30 mg, 60 mg, 75 mg, and 90 mg) or QW schedule (90 mg, 135 mg, 200 mg, 250 mg, and 300 mg) in repeating 4 week cycles, depending upon allocation.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to investigate the Dose Limiting Toxicities (DLTs),
      pharmacokinetics (PK), and pharmacodynamics (PD) of MK-2206 administered orally to
      participants with advanced solid tumors. The preliminary efficacy of MK-2206 will also be
      investigated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must have confirmed locally advanced or metastatic solid tumors that have
             failed to respond to standard therapy, have gotten worse or have come back after
             existing therapy

          -  Has normal organ function; is no greater than 2 on the ECOG Performance Scale

          -  Has a negative blood or urine pregnancy test within 72 hours of receiving the first
             dose of study drug if participant is female

          -  Is able to swallow capsules and has no surgical or bodily condition that will prevent
             the patient from swallowing and absorbing oral medications on an ongoing basis

        Exclusion Criteria:

          -  Participant has had chemotherapy, radiotherapy, biological therapy or surgery within 4
             weeks of starting the study and has not recovered from adverse events caused by the
             treatment

          -  Is currently participating or has participated in a study with an investigational
             compound or device within 30 days

          -  Has a primary central nervous system tumor

          -  Has a history or current evidence of heart disease, slow heart rate or untreated high
             blood pressure

          -  Is a known diabetic who is taking insulin or oral antidiabetic therapy

          -  Is pregnant or breastfeeding or planning to become pregnant during the study

          -  Is HIV-positive

          -  Has known history of Hepatitis B or C or active Hepatitis A

          -  Is receiving treatment with oral corticosteroids
Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTT-662 in Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: JTT-662; Placebo
Intervention description: Active drug tablets containing JTT-662; Placebo tablets matching in appearance to the active drug tablets
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: JTT-662; Diabetes; Safety; Tolerability; Pharmacokinetics; Pharmacodynamics

Summary:

      This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of
      JTT-662 administered once daily for 28 days in subjects with Type 2 diabetes mellitus (T2DM)
      who are receiving metformin monotherapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of T2DM for at least 12 weeks prior to the Screening Visit

          -  Currently treated with a stable oral dose of metformin monotherapy for at least 12
             weeks prior to the Screening Visit and until Day -3

          -  Have a glycosylated hemoglobin (HbA1c) value of between 6.5% and 10.0% at the
             Screening Visit

          -  Have a fasting plasma glucose (FPG) value of no more than 280 mg/dL at the Screening
             Visit and on Day -3

          -  Body Mass Index (BMI) of 25 to 40 kg/m2 (inclusive)

        Exclusion Criteria:

          -  Known medical history or presence of Type 1 diabetes mellitus, Maturity Onset Diabetes
             of the Young or secondary forms of diabetes

          -  Known medical history or presence of diabetic complications

          -  Have taken anti-diabetic medications (other than metformin) or medications that act
             mainly in the gastrointestinal tract (e.g., orlistat, acarbose) within 12 weeks prior
             to the Screening Visit or from the Screening Visit to Day -3

          -  Have uncontrolled hypertension (systolic blood pressure of at least 160 mmHg or
             diastolic blood pressure of at least 95 mmHg) at the Screening Visit

          -  Have impaired renal function (estimated glomerular filtration rate (eGFR) <60
             mL/min/1.73 m2)
A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerabiltiy of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: Betrixaban
Intervention description: 80 mg betrixaban qd for 8 days
Intervention MeSH terms: Betrixaban
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Betrixaban; Renal impairment; Healthy; Kidney dysfunction

Summary:

      The purpose of the study is to compare the pharmacokinetics, pharmacodynamics, and
      tolerability of betrixaban in patients with mild, moderate, and severe renal impairment to
      healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to understand and sign the written informed consent.

          -  Subjects should have either normal renal function or have stable renal disease

        Exclusion Criteria:

          -  Subjects require dialysis

          -  Evidence of active bleeding or bleeding disorder

          -  Unstable or clinically significant other disorders such as respiratory, hepatic,
             metabolic, psychiatric or gastrointestinal disorder
A Study to Investigate the Influence of Hepatic Impairment on MK-8189 Treatment (MK-8189-012)
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Intervention: MK-8189
Intervention description: Administered at a dose of 4 mg via oral tablet
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the pharmacokinetics (PK) of MK-8189 in participants
      with moderate hepatic impairment (based on the Child-Pugh classification) to healthy
      participants. This is Part 1 of the study; following review of the safety and PK data from
      Part 1, a decision will be made as to whether Part 2 of the study will be initiated. If done,
      Part 2 of the study will compare the PK of MK-8189 in participants with mild hepatic
      impairment to healthy participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is a continuous non-smoker or moderate smoker (of fewer than 20 cigarettes/day or
             equivalent)

          -  Female participant is not pregnant or breastfeeding and is not woman of childbearing
             potential (WOCBP) or is a WOCBP using contraception or abstinent from heterosexual
             intercourse during the intervention period and for at least 14 days after the last
             dose of study intervention

          -  (For hepatically impaired participants) Has a diagnosis of chronic (>6 months), stable
             (no acute episodes within the previous 2 months due to deterioration in hepatic
             function) hepatic impairment

        Exclusion Criteria:

          -  Has a history of clinically significant endocrine, gastrointestinal, cardiovascular,
             hematological, hepatic, immunological, renal, respiratory, genitourinary or major
             neurological abnormalities or diseases

          -  Has a history of cancer; exceptions include (1) adequately treated non-melanomatous
             skin carcinoma or carcinoma in situ of the cervix, (2) other successfully treated
             malignancies

          -  Has a history of significant multiple and/or severe allergies or has had significant
             intolerability to prescription or non-prescription drugs or food

          -  Is positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)

          -  Has had major surgery or lost 1 unit of blood within 4 weeks prior to prestudy visit

          -  Consumes greater than 3 glasses of alcoholic beverages per day

          -  Consumes greater than 6 servings (1 serving is ~120 mg of caffeine) caffeinated
             beverages per day

          -  (For hepatically impaired participants) Is taking medications to treat chronic medical
             conditions and has not been on a stable regimen for at least 1 month and/or is unable
             to withhold the use of the medications during study
Study to Compare 2 Formulations of LY900014 in Healthy Participants
Condition: Healthy
Intervention: LY900014 U-200; LY900014 U-100
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: 69.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study involves a comparison of 2 formulations of LY900014, which 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

          -  Had donated blood of more than 450 milliliters (mL) or participated in a clinical
             trial with similar blood loss 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
A Study of the Biodistribution and Safety of [18F]GTP1 in Healthy Japanese Participants
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: [18F]GTP1
Intervention description: [18F]GTP1 IV bolus injection of up to 370 megabecquerel (MBq) (10 millicurie [mCi]), with a maximum drug mass dose of 10 microgram (μg).
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the biodistribution, safety and tolerability of a
      single dose of [18F]GTP1 as a tau targeted radiopharmaceutical in healthy Japanese
      participants.
    

Eligibility criteria:

        Key inclusion criteria:

          -  Healthy with no clinically relevant finding on physical examination at screening and
             prior to radiopharmaceutical administration

          -  Female participants must be willing to avoid pregnancy and refrain from donating eggs
             during the treatment period and for 30 days after the final dose

          -  Male participants with partners of childbearing potential must commit to the use of
             two methods of contraception for the study duration and 90 days after the last dose

          -  Male participants must not donate sperm for the duration of the study and 90 days
             after the last dose

          -  Participants must have both Japanese parents and all Japanese grandparents

        Key exclusion criteria:

          -  Participants with any significant medical disorder or disease expected to interfere
             with the study

          -  Current or prior history (within a six-month period) of exposure to nicotine products

          -  History of drug or alcohol abuse within 12 months prior to screening

          -  Prior participation in other research protocols or clinical care in the last year,
             such that radiation exposure combined with that from the present study exceeds an
             effective dose of 50 millisievert (mSv), the allowable annual limit for research
             participants as established by the US Federal Guidelines

          -  Use of any prescription drugs, herbal supplements, within 4 weeks prior to initial
             dosing

          -  Use of over the counter (OTC) medication, dietary supplements, or vitamins, within 2
             weeks prior to initial dosing

          -  Known hypersensitivity to any component of the formulation of [18F]GTP1 or related
             compounds

          -  Major surgery, or donation or loss of 400 mL or more of blood within 4 weeks prior to
             initial dosing

          -  History of immunodeficiency diseases, including positive human immunodeficiency virus
             (HIV) test

          -  Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody

          -  Women who are pregnant, lactating or breastfeeding

          -  Unsuitable veins for repeated venipuncture