bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Milvexian Using an IV Microtracer With Additional Formulation and Food Effect Comparison in Healthy Participants
Condition: Healthy Volunteers
Intervention: BMS-986177 Oral Solution; [14C]BMS-986177 Solution for Infusion; BMS-986177 Spray-dried Dispersion Capsules
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Pharmaceutical Solutions
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioavailability; BMS-986177; 14C-Microtracer; Milvexian

Summary:

      The purpose of this study is to evaluate the absolute oral bioavailability (amount of drug
      entering the bloodstream) of spray-dried dispersion (SDD) milvexian capsules in the fed and
      fasted states, and to bridge the exposures seen using only the oral solution.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, 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 18.0 to 32.0 kg/m², inclusive. BMI = weight (kg)/ (height
             [m])²

        Exclusion Criteria:

          -  History of gastrointestinal (GI) disease, upper or lower GI bleeding within 6 months,
             intracranial bleeding, tumor, aneurysms

          -  History or evidence of abnormal bleeding or coagulation disorder and/or evidence of
             coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent
             unexplained bruising or thrombus formation, or a history of spontaneous bleeding, such
             as epistaxis, or family history of coagulopathies

          -  Any acute or chronic medical illness considered clinically significant by the
             investigator

          -  History of clinically significant cardiovascular, renal, hepatic, dermatological,
             chronic respiratory, neurological or psychiatric disorder, as judged by the
             investigator

        Other protocol-defined inclusion/exclusion criteria apply
A Study of LY2510924 and Durvalumab in Participants With Solid Tumors
Condition: Solid Tumor
MeSH terms: Neoplasms
Intervention: LY2510924; Durvalumab
Intervention description: Administered SQ; Administered IV
Intervention MeSH terms: Durvalumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: immuno-oncology

Summary:

      The main purpose of this study is to evaluate the safety and tolerability of chemokine (C-X-C
      Motif) receptor 4 (CXCR4) peptide antagonist LY2510924 and durvalumab for phase 1a and 1b in
      participants with advanced refractory solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Phase 1a: Have histologic or cytologic confirmation of advanced solid tumor

          -  Have at least 1 measurable lesion assessable using standard techniques by Response
             Evaluation Criteria in Solid Tumours (RECIST) v1.1

          -  Have adequate organ function

          -  Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
             scale

          -  Have provided tissue from a newly obtained core or excisional biopsy of a tumor lesion
             or a recent biopsy defined by ≤3 years since last documented progression of disease

          -  Have an estimated life expectancy of ≥12 weeks, in the judgment of the investigator

        Exclusion Criteria:

          -  Have a serious concomitant systemic disorder including human immunodeficiency virus
             (HIV), active hepatitis B virus (HBV), active HCV, active autoimmune disorder or
             disease requiring high dose of steroids

               -  Have a bowel obstruction, history or presence of inflammatory enteropathy or
                  extensive intestinal resection or chronic diarrhea

               -  Have evidence of interstitial lung disease that is symptomatic or may interfere
                  with the detection or management of suspected drug-related pulmonary toxicity or
                  active, noninfectious pneumonitis

               -  Have an active infection requiring systemic therapy

          -  Have had prior therapy with an anti-programmed cell death 1 (PD-1), anti-PD-L1,
             anti-PD-L2, or anticytotoxic T lymphocyte-associated antigen-4 antibody

          -  Moderate or severe cardiovascular disease

          -  Have symptomatic or uncontrolled brain metastases, spinal cord compression, or
             leptomeningeal disease requiring concurrent treatment

          -  Have received a live vaccine within 30 days before the first dose of study treatment
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male Subjects
Condition: Healthy
Intervention: SB4; EU sourced Enbrel; US sourced Enbrel
Intervention description: SC administration; SC administration; SC administration
Intervention MeSH terms: Etanercept
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 138.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pharmacokinetics

Summary:

      The purpose of this study is to compare the pharmacokinetics, safety and immunogenicity of
      SB4 and Enbrel (EU sourced Enbrel and US sourced Enbrel) in healthy male subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male subjects

          -  Have a body weight between 60 and 94.9 kg and a body mass index between 20.0 and 29.9
             kg/m², inclusive.

        Exclusion Criteria:

          -  history and/or current presence of clinical significant atopic allergy,
             hypersensitivity or allergic reactions, also including known or suspected clinically
             relevant drug hypersensitivity to any components of the test and reference IP
             formulation or comparable drugs.

          -  active or latent Tuberculosis or who have a history of TB.

          -  history of invasive systemic fungal infections or other opportunistic infections

          -  systemic or local infection, a known risk for developing sepsis and/or known active
             inflammatory process

          -  serious infection associated with hospitalisation and/or which required intravenous
             antibiotics

          -  history of and/or current cardiac disease

          -  have received live vaccine(s) within 30 days prior to Screening or who will require
             live vaccine(s) between Screening and the final study visit.

          -  Intake medication with a half-life > 24 h within 1 month or 10 half-lives of the
             medication prior to the first administration of IP.
PF-06671008 Dose Escalation Study in Advanced Solid Tumors
Condition: Neoplasms
MeSH terms: Neoplasms
Intervention: PF-06671008; PF-06671008
Intervention description: Dose Escalation Phase - Part 1; Dose Expansion Phase - Part 2
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: P-cadherin; PF-06671008; solid tumors; lung cancer; breast cancer; colorectal cancer; NSCLC; TNBC; CRC; neoplasms; Triple negative breast cancer; Non-small cell lung cancer

Summary:

      The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses
      of PF-06671008 in patients with advanced solid tumors with the potential to have P-cadherin
      expression. The study will then expand to look at the selected dose in patients with
      P-cadherin expressing TNBC, CRC or NSCLC.
    

Eligibility criteria:

        Key Inclusion Criteria

          -  Diagnosis of tumor type with the potential to have P-cadherin expression that is
             resistant to standard therapy or for which no standard therapy is available

          -  Performance status of 0 or 1

          -  Adequate bone marrow, kidney and liver function

        Key Exclusion Criteria

          -  Known CNS disease including, but not limited to, metastases

          -  Current or history of seizure disorder

          -  History of or active autoimmune disorders

          -  Active bacterial, fungal or viral infection

          -  Major surgery, anti-cancer therapy, or radiation therapy within 4 weeks of study
             treatment

          -  Requirement for systemic immune suppressive medication

          -  Grade 2 or greater peripheral neuropathy
Phase 1 TAK-925 Study in Healthy Adult and Elderly Volunteers and Participants With Narcolepsy
Condition: Healthy Participants and Patients With Narcolepsy
MeSH terms: Narcolepsy
Intervention: TAK-925; Placebo
Intervention description: TAK-925 Intravenous Infusion; TAK-925 Placebo Intravenous Infusion
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to investigate safety, tolerability, and pharmacokinetics of
      TAK-925 when a single dose of TAK-925 is administered to healthy adult participants, healthy
      elderly participants and patients with type 1 narcolepsy.
    

Eligibility criteria:

        Inclusion Criteria:

        Healthy adult participants and Healthy elderly participants:

        - Participant weighs at least 50 kilogram (kg) (Healthy adults participants) / 40 kg
        (Healthy elderly participants) and has a body mass index (BMI) from 18.5 to 30 kilogram per
        square meter (kg/m^2), inclusive at Screening.

        Narcolepsy patients:

          -  Patient weighs at least 40 kg inclusive at Screening.

          -  A diagnosis of narcolepsy Type 1, as defined by the International Classification of
             Sleep Disorders, Third Edition (ICSD-3).

          -  HLA narcolepsy test positivity.

          -  At Day -1, Epworth sleepiness scale (ESS) score greater than or equal to (>=) 10

          -  Blood pressure less than (<) 140 systolic and < 90 diastolic. The patient may have a
             history of hypertension and be on antihypertensive medication treatment as long as the
             BP meets these criteria.

        Exclusion Criteria:

        All Participants:

          -  Participant has a history of drug abuse (defined as any illicit drug use) or a history
             of alcohol abuse within 2 years prior to the Screening visit.

          -  Past or current epilepsy, convulsion, tremor or the disorders of related symptoms.

          -  Has a lifetime history of major psychiatric disorder, such as major depressive
             disorder, bipolar disorder, or schizophrenia.

        HV (only Cohort 4):

        - Participant has had CSF collection performed within 14 days prior to check-in (Day -1).

        Narcolepsy patients

          -  Medical disorder associated with excessive sleepiness other than narcolepsy (including
             sleep apnea syndrome).

          -  Excessive caffeine (greater than [>] 400 milligram per day [mg/day]) use one week
             prior to study.
Study of Quizartinib in Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Quizartinib; Cytarabine; Idarubicin; Daunorubicin
Intervention description: [Induction period, Cycle 1] Once-daily repeated oral administration Day 8 to Day 21.
[Induction period, Cycle 2] Once-daily repeated oral administration Day 6 to Day 19.
[Consolidation period] Once-daily repeated oral administration Day 6 to Day 19.; [Induction period, Cycle 1] Once-daily intravenous injection of 100 mg/m^2 cytarabine on Day 1 to 7.
[Induction period, Cycle 2] Once-daily intravenous injection of 100 mg/m^2 cytarabine on Day 1 to 5.
[Consolidation period] Twice-daily intravenous injection of 3.0 g/m^2 cytarabine at 12-hour intervals on Days 1, 3, and 5.; Either Idarubicin or Daunorubicin will be used [Induction period, Cycle 1] Once-daily intravenous injection of 12 mg/m^2 idarubicin on Day 1 to 3.
[Induction period, Cycle 2] Once-daily intravenous injection of 12 mg/m^2 idarubicin on Day 1 and 2.; Either Idarubicin or Daunorubicin will be used [Induction period, Cycle 1] Once-daily intravenous injection of 60mg/m^2 daunorubicin on Day 1 to 3.
[Induction period, Cycle 2] Once-daily intravenous injection of 60mg/m^2 daunorubicin on Day 1 and 2.
Intervention MeSH terms: Cytarabine; Daunorubicin; Idarubicin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: AML; phase 1; hematology; malignancy; newly diagnosed

Summary:

      This is a phase 1b, dose escalation, study of quizartinib to evaluate the safety profile, the
      pharmacokinetics, and the recommended dose of quizartinib for subsequent clinical studies of
      the combination of quizartinib and induction and consolidation chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  No prior treatment for AML (including quizartinib)

          -  ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 to 2

        Exclusion Criteria:

          -  Diagnosis of acute promyelocytic leukemia

          -  Active acute or chronic systemic fungal, bacterial, or viral infection not well
             controlled by antifungal, antibacterial or antiviral therapy.
Treatment Development for Glucose Transporter Type I Deficiency Syndrome (G1D)
Condition: Glucose Transporter Type 1 Deficiency Syndrome; GLUT1 Deficiency Syndrome
MeSH terms: Syndrome
Intervention: Triheptanoin
Intervention description: Triheptanoin is a 7-carbon medium chain triglyceride
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 1 Month
Maximum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: G1D; Glut1 Disorder; Glucose Transporter Type 1 Disorder; Glucose Transporter Type I Disorder

Summary:

      The purpose of this trial is to determine if an alternative energy source will impact brain
      metabolism in a disorder characterized by glucose metabolism failure in the brain.

      The central hypothesis tested in this investigation is whether circumventing impaired glucose
      metabolism is feasible, safe and potentially promising by supplying anaplerotic precursors
      through metabolism of odd-carbon fatty acids that can enter the citric acid cycle (CAC)
      through alternative metabolic pathways.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female

          -  Ages 1 month to <21 years of age

          -  Diagnosed with glucose transporter type I deficiency.

          -  Age matched (within 1 year) controls not diagnosed with G1D.

        Exclusion Criteria:

          -  All subjects carrying body metal implants incompatible with the exposure to a magnetic
             field

          -  Subjects unable to tolerate the MRI and MRS procedures due to anxiety

          -  Subjects receiving oxygen supplementation or those confined to a bed or stretcher

          -  Subjects currently receiving a ketogenic diet, due to a high risk of seizure
             recurrence while transitioning off ketosis.

          -  Patients behaviorally unable to hold still for imaging procedures (rather than limited
             by seizure activity) will be excluded.
A Study of LY3314814 in Healthy Participants
Condition: Healthy
Intervention: LY3314814; [13C415N3] LY3314814
Intervention description: Administered orally; Administered as an IV infusion
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: Open label
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to measure how much LY3314814 gets into the bloodstream when it
      is given as a single dose by mouth and as an intravenous (IV) infusion over two hours. The
      study will last at least two weeks for each participant, not including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males or females

          -  Have venous access sufficient to allow for blood sampling and intravenous (IV)
             administration of the investigational product

        Exclusion Criteria:

          -  Have a history of significant ophthalmic disease

          -  Have vitiligo or any other clinically significant disorder of skin pigmentation

          -  Have a history of use of antipsychotic drugs, or chronic use of antidepressant or
             anxiolytic drugs, prescribed as well as non-prescribed
Single Dose CHG Pharmacokinetic Study
Condition: Surgical Skin Preparation
Intervention: Chlorhexidine Gluconate
Intervention description: 2% CHG
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Masking description: laboratory-blinded, 3-period, 3-sequence, crossover study
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A single 2% topical application of ReadyPrep® CHG was applied on either the abdomen
      (Treatment-1) or the groin (Treatment-2) whereas Treatment-3 consisted of a control treatment
      where the same procedure as Treatment-1 and -2 was performed, but without the topical
      application of ReadyPrep® CHG. The treatments were separated by a wash-out of 7 calendar
      days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects were male or female, aged ≥ 18 and ≤ 60 years (inclusive). The main inclusion
             criteria were:

               -  non- or ex-smokers

               -  body mass index (BMI) ≥19.00 kg/m2 and ≤32.00 kg/m2 and a body weight ≥ 55 kg

               -  negative pregnancy test for female subjects

               -  healthy according to medical history, complete physical examination (including
                  vital signs and skin examination) and laboratory tests (general biochemistry,
                  hematology and urinalysis)
Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy
Condition: Japanese Patients With ALS
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Intervention: MT-1186
Intervention description: Suspension
Intervention MeSH terms: Edaravone
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Amyotrophic
      Lateral Sclerosis Patients with gastrostomy
    

Eligibility criteria:

        Inclusion Criteria:

        The key criteria are listed below.

          -  Patients aged between 20 and 80 years at the time of informed consent

          -  Japanese patients

          -  Among patients with ALS, those "Clinically definite ALS," "Clinically probable ALS" or
             "Clinically probable-laboratory-supported ALS" according to El Escorial Revised Airlie
             House criteria

          -  ALS Patients with gastrostomy

          -  Patients who can consent to contraception

          -  Patients who have thoroughly understood the contents of the study and voluntarily
             provided written informed consent to participate in the study

        Exclusion Criteria:

        The key criteria are listed below.

          -  Patients in whom the possibility could not be ruled out that the current symptoms were
             symptoms of a disease requiring differential diagnosis, such as cervical spondylosis
             and multifocal motor neuropathy

          -  Patients undergoing treatment for malignancy.

          -  Patients who have presence of clinically significant liver, heart, or renal disease
             requiring hospitalization (except ALS) and infections requiring antibiotics. Patients
             who have a problem in general condition and are judged ineligible by the Investigator

          -  Body mass index (BMI) of <15.0 or >30.0, or a body weight of <40 kg

          -  Patients judged by the investigator (or subinvestigator) to be unsuitable for the
             study for any other reason