bioihbjkbjnl/mcl2 huggingface dataset:
A Study of LY900014 Administered in Participants With Type 1 Diabetes Using an Insulin Pump
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY900014; Insulin Lispro (Humalog)
Intervention description: Administered subcutaneously (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: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study will be conducted in participants with type 1 diabetes mellitus to investigate how
      the human body processes LY900014, a new blood sugar lowering insulin, and its effect on
      blood sugar levels when it is delivered via an insulin pump. Side effects and tolerability
      will be documented. The study will last about 4 to 11 weeks for each participant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants with Type 1 Diabetes Mellitus (T1DM) who are receiving
             insulin therapy via an approved insulin pump

          -  Have a screening body mass index (BMI) of greater than 18.5 to 33.0 kilograms per
             meter squared (kg/m²), inclusive

          -  Have medical and laboratory test results that are acceptable for the study

          -  Have had no episodes of severe hypoglycemia (requiring assistance in treatment by a
             second party) in the past 6 months

          -  Have venous access sufficient to allow for blood sampling

          -  Have provided written consent and are willing to follow study procedures and commit to
             the study duration

        Exclusion Criteria:

          -  Are currently participating or recently participated in a clinical trial or any other
             type of medical research judged to be incompatible with this study

          -  Had blood loss of more than 500 milliliters (mL) within the last month

          -  Have known allergies to LY900014, insulin lispro, related compounds or any components
             in the study drug formulations

          -  Have previously participated or withdrawn from this study

          -  Have or used to have health problems or medical test results that, in the opinion of
             the doctor, could make it unsafe to participate, or could interfere with understanding
             the results of the study
A Pharmacokinetic Study of TAK-438 in Healthy Adult Chinese Participants
Condition: Healthy Participants
Intervention: TAK-438
Intervention description: TAK-438 tablets.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to determine the pharmacokinetics (PK) of TAK-438 in healthy
      adult Chinese participants after both single and multiple dose administration.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is a healthy adult male or female Chinese participant.

          2. Is aged 18 to 45 years, inclusive, at the time of signing the informed consent form.

          3. Weighs at least 50 kilogram (kg) and has a body mass index (BMI) between 19 and 26
             kilogram per square meter (kg/m^2), inclusive at Screening (Check-In Day -1).

          4. Is willing to abstain from caffeine and alcohol from 72 hours before first dose (Day
             1) until the Follow-up Visit on Day 18.

          5. Is willing to abstain from strenuous exercise from 72 hours before first dose (Day 1)
             until the Follow-up Visit on Day 18.

          6. Is willing to provide a sample for pharmacogenetic analysis (for cytochrome [CYP2C19]
             genotyping).

        Exclusion Criteria:

          1. Has uncontrolled, clinically significant cardiovascular disease or other abnormality,
             which may impact the ability of the participant to participate or potentially confound
             the study results.

          2. Is lactose intolerant or has a known hypersensitivity to any component of the
             formulation of TAK-438.

          3. Has poor peripheral venous access.

          4. Has donated or lost 400 milliliter (mL) or more of his or her blood volume (including
             plasmapheresis), or had a transfusion of any blood product within 90 days prior to Day
             1; or participant has donated or lost more than 200 mL or more of his or her blood in
             the last 28 days.

          5. Has a history of symptomatic gastroesophageal reflux disease (GERD), Erosive
             Esophagitis, duodenal ulcer (DU), gastric ulcer (GU), dyspepsia, Barrett's Esophagus,
             or Zollinger-Ellison (ZE) syndrome or has current or recent (within 6 months)
             gastrointestinal disease that would be expected to influence the absorption of drugs.
Staccato Loxapine Thorough QT/QTc Study
Condition: Thorough QT/QTc Study
Intervention: Inhaled loxapine; Inhaled placebo; Oral moxifloxacin; Oral placebo
Intervention description: Inhaled Staccato Loxapine 10 mg single dose; Inhaled Staccato placebo single dose; Oral moxifloxacin 400 mg; Oral placebo similar in appearance to moxifloxacin 400 mg
Intervention MeSH terms: Moxifloxacin; Loxapine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double blind, double dummy
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Staccato loxapine; QT/QTc; healthy volunteers; Thorough QT/QTc study; ADASUVE; inhaled loxapine

Summary:

      The purpose of the present Phase 1 study was to assess the cardiac safety of Staccato
      Loxapine administered to healthy volunteers in a 3 period crossover study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who are in good general health and agree to use a medically acceptable and
             effective birth control method throughout the study.

        Exclusion Criteria:

          -  Subjects who have taken prescription or nonprescription medication within 5 days of
             treatment,

          -  Subjects who have had an acute illness within the last 5 days of treatment,

          -  Subjects who are smokers, OR

          -  Subjects who have an ECG abnormality at baseline.
A Study of Tirzepatide at Different Injection Sites in Participants With Different Body Sizes
Condition: Healthy
Intervention: Tirzepatide
Intervention description: Tirzepatide administered SC
Intervention MeSH terms: Tirzepatide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the amount of tirzepatide that gets into the blood
      stream and how long it takes the body to get rid of it, when injected under the skin of the
      upper arm and thigh compared to the abdomen. The study will be conducted in healthy males and
      females with different body sizes. The tolerability of tirzepatide will be evaluated and
      information about any side effects experienced will be collected. For each participant, the
      study will last about 20 weeks, including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males or females of nonchildbearing potential as determined by medical
             history, physical examination, and other screening procedures

          -  Are between the body mass index (BMI) of 18.5 and 45.0 kilograms per meter squared
             (kg/m²), inclusive, at screening

          -  Are agreeable to receiving study treatment by injections under the skin

        Exclusion Criteria:

          -  Have known allergies to tirzepatide or related compounds

          -  Have a personal or family history of medullary thyroid carcinoma or have multiple
             endocrine neoplasia syndrome type 2

          -  Have a history or presence of pancreatitis (history of chronic pancreatitis or
             idiopathic acute pancreatitis), elevation in serum amylase or lipase or
             gastrointestinal (GI) disorder (eg, relevant esophageal reflux or gall bladder
             disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery,
             pyloric stenosis, with the exception of appendectomy) or could be aggravated by
             glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors

          -  Have a prior history of malignant disease(s) in the past 5 years prior to screening

          -  Smoke more than the equivalent of 10 cigarettes per day

          -  Is a known user of drugs of abuse
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06882961 in Japanese Adults With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; PF-06882961
Intervention description: 3 matching placebo tablets taken twice a day (BID); Participants will be randomized to one of 3 active doses (40, 80, or 120 mg), taking 3 tablets twice daily for 8 weeks.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 37.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This is a Phase 1, randomized, double blind (sponsor open), parallel, placebo controlled,
      twice daily oral dosing study of PF 06882961 in adult Japanese participants with T2DM
      inadequately controlled on diet and exercise alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with T2DM who are treated with diet and exercise

          -  HbA1c greater than or equal to 7% and less than or equal to 10.5%

          -  Total body weight >50 kg (110 lb) with BMI 22.5 to 45.4 kg/m^2

        Exclusion Criteria:

          -  Any condition possibly affecting drug absorption

          -  Diagnosis of Type 1 diabetes

          -  History of myocardial infarction, unstable angina, arterial revascularization, stroke,
             heart failure, or transient ischemic attack within 6 months of screening

          -  Any malignancy not considered cured

          -  Personal or family history of MTC or MEN2, or participants with suspected MTC

          -  Acute pancreatitis or history of chronic pancreatitis

          -  Symptomatic gallbladder disease

          -  Known medical history of active proliferative retinopathy and/or macular edema

          -  Known history of HIV, hepatitis B, hepatitis C or syphilis

          -  Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or
             equal to 100 mmHg (diastolic)

          -  Clinically relevant ECG abnormalities

          -  Positive urine drug test
Phase 1 Study of ALXN1840 on the Metabolism of a CYP2C9 Substrate in Healthy Participants.
Condition: Wilson Disease
MeSH terms: Hepatolenticular Degeneration
Intervention: ALXN1840; Celecoxib
Intervention description: ALXN1840 was administered orally as a single dose as 4 x 15 milligram (mg) enteric-coated tablets with 240 milliliters (mL) of water (fasting), for a total dose of 60 mg.; Celecoxib was administered orally as a single dose as one 200-mg tablet with 240 mL of water (fasting).
Intervention MeSH terms: Celecoxib; Tetrathiomolybdate; Choline
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants were randomized to 1 of 2 treatment sequences: A-B or B-A.
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cytochrome P450; Healthy; ALXN1840; Celecoxib; CYP2C9

Summary:

      This was a Phase 1, randomized, 2-period, 2-sequence, cross-over study designed to determine
      the effect of ALXN1840 on the metabolism of celecoxib, a sensitive cytochrome P450 2C9
      (CYP2C9) substrate, in healthy male and female participants. The safety and tolerability of
      ALXN1840 were determined along with ALXN1840 pharmacokinetics (PK) in plasma as measured via
      total molybdenum with the coadministration of celecoxib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adequate venous access in the left or right arm to allow the collection of blood
             samples.

          -  Bodyweight ≥ 45 to ≤ 100 kilograms (kg) and body mass index within the range of 18 to
             < 30 kg/meter squared.

          -  Willing and able to follow protocol-specified contraception requirements.

          -  Capable of giving signed informed consent.

        Exclusion Criteria:

          -  History or presence of/significant medical history.

          -  Clinically significant multiple or severe allergies.

          -  Lymphoma, leukemia, or any malignancy within 5 years.

          -  Breast cancer within the past 10 years.

          -  Serum creatinine > upper limit of normal (ULN) of the reference range.

          -  Alanine aminotransferase, aspartate aminotransferase, or total bilirubin > ULN.

          -  Current or chronic history of liver disease or known hepatic or biliary abnormalities
             (with the exception of Gilbert's syndrome or asymptomatic gallstones).

          -  QTc > 450 milliseconds (msec) for male participants or > 470 msec for female
             participants.
To Demonstrate Similarity of Pharmacokinetics and Evaluate Safety of CT-P16, EU-Approved Avastin and US-licensed Avastin
Condition: Healthy
Intervention: CT-P16; EU-approved Avastin; US-licensed Avastin
Intervention description: CT-P16 is a biosimilar product for Avastin; EU-approved Avastin; US-licensed Avastin
Intervention MeSH terms: Bevacizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 141.0
Sex: Male
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: safety; Pharmacokinetics; Immunogenicity

Summary:

      This study is a Phase 1 Randomized, Double-blind, Three-arm, Parallel Group, Single-dose
      Study to compare the PK, safety and immunogenicity of the proposed biosimilar test product
      CT-P16 with EU-approved Avastin and US-licensed Avastin after a single IV infusion of 5mg/kg
      of each product to healthy male subjects
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male subjects between the ages of 19 and 55 years, both inclusive

          -  Body Mass Index (BMI) between 18.0 and 29.9 kg/m2 (both inclusive) and a body weight ≥
             50 kg

        Exclusion Criteria:

          -  Subject is a female.

          -  Clinically significant allergic reactions, hypersensitivity

          -  A disease classed as significant by the Investigator

          -  Non-healing wound, ulcer, bone fracture, a major surgical procedure, significant
             traumatic injury

          -  Any malignancy

          -  Undergone treatment with an investigational drug or participated in another clinical
             trial

          -  Plans to father a child or donates sperms
To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects
Condition: Healthy
Intervention: CT-P39; EU-approved Xolair; CT-P39; EU-approved Xolair; US-licensed Xolair
Intervention description: 150 mg/mL, Solution for injection in PFS; 150 mg/mL, Solution for injection in PFS; 150 mg/mL, Solution for injection in PFS; 150 mg/mL, Solution for injection in PFS; 150 mg/mL, Solution for injection in PFS
Intervention MeSH terms: Omalizumab; Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 176.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare
      the Pharmacokinetics and Safety of Three Formulations of Omalizumab (CT-P39, EU-approved
      Xolair, and US-licensed Xolair) in Healthy Subjects
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subject (male or female) between the ages of 18 and 55 years.

          -  Subject with a body weight of > 40 kg and ≤ 90 kg and a BMI between 18.0 kg/m2 and
             32.0 kg/m2(both inclusive).

          -  Subject with a total IgE level of ≤ 100 IU/mL.

        Exclusion Criteria:

          -  Subject has a medical history and/or current presence of disease including one or more
             of the allergic reaction.
A Study of Tirzepatide Administered by Two Different Devices in Healthy Participants
Condition: Healthy
Intervention: Tirzepatide; Prefilled syringe (PFS); Auto-injector (AI)
Intervention description: Administered SC; PFS used to administer tirzepatide; AI used to administer tirzepatide
Intervention MeSH terms: Tirzepatide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the amount of tirzepatide that gets into the blood
      stream and how long it takes the body to get rid of it, when given as a solution formulation
      via an autoinjector versus a conventional prefilled syringe. The tolerability of tirzepatide
      will also be evaluated and information about any adverse effects experienced will be
      collected.

      Screening is required within 28 days prior to the start of the study. For each participant,
      the total duration of the clinical trial will be about 14 weeks, including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males or females of nonchildbearing potential as determined by medical
             history, physical examination, and other screening procedures

          -  Are between the body mass index (BMI) of 18.0 and 32.0 kilograms per meter squared
             (kg/m²), inclusive, at screening

          -  Are agreeable to receiving study treatment by injections under the skin

        Exclusion Criteria:

          -  Have known allergies to tirzepatide or related compounds

          -  Have a personal or family history of medullary thyroid carcinoma or have multiple
             endocrine neoplasia syndrome type 2

          -  Have a history or presence of pancreatitis (history of chronic pancreatitis or
             idiopathic acute pancreatitis), elevation in serum amylase or lipase or GI disorder
             (eg, relevant esophageal reflux or gall bladder disease) or any GI disease which
             impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the
             exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1)
             analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors

          -  Have a prior history of malignant disease(s) in the past 5 years prior to screening

          -  Smoke more than the equivalent of 10 cigarettes per day

          -  Is a known user of drugs of abuse
A Phase 1 Study of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: OCV-103 and OCV-104; OCV-103 and OCV-104; OCV-103 and OCV-104; OCV-103 and OCV-104
Intervention description: 0.3 mg of each; 1 mg of each; 3 mg of each; 6 mg of each
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: 20 Years
Healthy volunteers: No
Keywords: OCV-C02; Colorectal Cancer; Antigen specific cancer immunotherapeutic

Summary:

      To assess the safety and tolerability of OCV-C02 in Patients With Advanced or Relapsed
      Colorectal Cancer Who Are Refractory or Intolerant to Standard Chemotherapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have human leukocyte antigen (HLA)-A*24:02

          -  Patients who have histologically-confirmed colorectal cancer (adenocarcinoma)

          -  Patients with advanced or relapsed colorectal cancer who are refractory or intolerant
             to standard chemotherapy

          -  Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of
             0 to 1 at the time of enrollment in the trial.

        Exclusion Criteria:

          -  Patients who are HIV antibody test positive

          -  Patients with an active infection

          -  Patients who have or are suspected to have CNS metastasis of colon cancer (such as
             metastatis of the brain)