bioihbjkbjnl/mcl2 huggingface dataset:
Clearance of 25-hydroxyvitamin D in Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: D6-25-hydroxyvitamin D3
Intervention description: Intravenous administration of a deuterium-labeled 25(OH)D3 to evaluate the metabolic clearance of 25(OH)D3
Intervention MeSH terms: Hydroxycholecalciferols; Calcifediol
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chronic kidney disease; vitamin d catabolism

Summary:

      The goal of this study is to better understand vitamin D catabolism and how it is affected by
      CKD and race.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Self-reported race Caucasian, African American, or African

          -  Serum total 25(OH)D 10-50 ng/mL

          -  Estimated GFR:

               -  60 mL/min/1.73m2 (N=40) 15-45 mL/min/1.73m2 (N=40) <15 mL/min/1.73m2, treated
                  with hemodialysis (N=40)

        Exclusion Criteria:

          -  Primary hyperparathyroidism

          -  Gastric bypass

          -  Tuberculosis or sarcoidosis

          -  Current pregnancy

          -  Child-Pugh Class B or C cirrhosis (i.e. cirrhosis with ascites, hepatic
             encephalopathy, bilirubin >=2 mg/dL, serum albumin <=3.5 g/dL, or PT >= 4 seconds)

          -  Use of vitamin D3, or vitamin D2 supplements exceeding a mean daily dose of 400 IU,
             within 3 months (wash-out allowed)

          -  Use of 1,25(OH)2D3 or an analogue, calcimimetics, or medications known to induce
             CYP24A1 within 4 weeks (wash-out allowed)

          -  Serum calcium > 10.1 mg/dL

          -  Hemoglobin < 10 g/dL
Study to Evaluate Safety and Tolerability of sc Immunotherapy With DM-101 in Adults With Birch Pollen Allergy
Condition: Birch Pollen Allergy
MeSH terms: Rhinitis, Allergic, Seasonal; Hypersensitivity
Intervention: DM-101; Placebo to match DM-101
Intervention description: DM-101 administered by subcutaneous (SC) injection; Placebo to match DM-101 administered by SC injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: 4 sequential study cohorts with ascending DM-101 doses. In each cohort two treatment arms: placebo and active drug
Masking: Double (Participant, Investigator)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Randomized, double-blind placebo-controlled phase I study to investigate the safety and
      tolerability of ascending doses of DM-101 in adult subjects with birch pollen allergy.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Males or females, aged 18 to 65 years

          -  Good general health

          -  A documented clinical history of birch pollen-induced allergic rhinitis or
             rhinoconjunctivitis with symptoms that interfere with daily activities or sleep and
             remain bothersome despite the use of relevant symptomatic medication, and have been
             present over, at least, 2 allergy seasons.

          -  Bet v 1 specific serum IgE ≥ 0.7 kU/L

          -  Positive SPT to birch pollen allergen, with a wheal diameter ≥ 5 mm

          -  Body weight ≥50 kg and body mass index (BMI) within the range 18-35 kg/m2.

        Key Exclusion Criteria:

          -  History or findings on physical examination of any significant disease or disorder
             which, in the opinion of the Investigator, may put the subject at risk because of
             participation in the study, influence the results of the study or the subject's
             ability to participate in the study.

          -  Current diagnosis of asthma (other than seasonal during the birch pollen allergy
             season), requiring Global Initiative for Asthma (GINA) Step 2 or higher treatment, or
             asthma partially controlled or uncontrolled according to GINA classification in the 6
             months before Screening.

          -  History of asthma deterioration that resulted in emergency treatment or
             hospitalisation in the 12 months before screening, or a life-threatening asthma attack
             at any time in the past.

          -  Forced Expiratory Volume in one second (FEV1) < 70% of predicted, regardless of asthma
             status at screening or baseline assessment at the first dosing visit.

          -  History of severe drug allergy, severe angioedema or systemic allergic reaction of
             Grade 3 or greater, according to the World Allergy Organization (WAO) scale, due to
             any cause.
A Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets
Condition: Healthy Participants
Intervention: Sotorasib
Intervention description: Oral Tablet
Intervention MeSH terms: Sotorasib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 146.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Sotorasib; AMG 510

Summary:

      The primary objective of the study is to compare the pharmacokinetics (PK) of sotorasib
      administered orally as 1 tablet under fasted conditions to sotorasib administered orally as 2
      tablets under fasted conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 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 participants
             safety or interfere with the study evaluation, procedures, or completion.
A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY900014; Insulin Lispro
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: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which
      is a drug that lowers blood sugar. The study will look at how the body processes LY900014,
      and the effect of LY900014 on blood sugar levels following a standard meal. For each
      participant, the study will consist of 4 periods and there will be approximately 12 weeks
      from screening to final study follow up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are male or female participants with Type 1 Diabetes Mellitus (T1DM) for at least 1
             year

          -  Have a body mass index (BMI) of 18.5 kilogram per meter square (kg/m²) to 35.0 kg/m²

          -  Have a glycated hemoglobin (HbA1c) ≤9.0% at screening

          -  Are on stable prandial insulin and basal insulin (neutral protamine Hagedorn [NPH]
             insulin, insulin glargine or insulin detemir) for at least 3 months before screening
             with a total insulin dose demand of less than or equal to (≤) 1.5 units per kilogram
             per day (U/kg/day)

        Exclusion Criteria:

          -  Are currently enrolled, or have participated within the last 30 days, in a clinical
             trial or any other type of medical research

          -  Have or used to have health problems that, in the opinion of the doctor, could make it
             unsafe to participate in the study

          -  Have donated blood of more than 450 millilitre (mL) or more in the last 3 months or
             provided any blood donation within the last month before screening.

          -  Any significant changes in insulin regimen and/or unstable blood glucose control
             within the past 3 months prior to screening as assessed by the investigator.

          -  Are treated with a CSII (insulin pump)
Study to Assess Safety, Tolerability and Phamacokinetics of KAE609 Administered Intravenously in Healthy Subjects
Condition: Malaria
MeSH terms: Malaria
Intervention: KAE609; Placebo
Intervention description: iv bolus administration over approximately 2 min for doses < 75 mg (Cohorts A1, A2 and B1)
iv infusion over approximately 10 min for doses ≥ 75 mg (Cohorts A3, A4, A5 and B2); matching placeo for iv administration
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: safety; tolerability; pharmacokinetics; healthy volunteers; phase 1; malaria; intravenous; iv; KAE609; Placebo

Summary:

      This was a randomized, subject and investigator-blinded, placebo-controlled, single and
      multiple ascending intravenous (iv) dose study in healthy subjects to assess the safety and
      tolerability of KAE609 given in the vein.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Healthy male and female subjects 18 to 55 years of age inclusive, and in good health
             as determined by past medical history, physical examination, vital signs,
             electrocardiogram, and laboratory tests.

          -  Subjects must weigh at least 50 kg to participate in the study, and must have a body
             mass index (BMI) within the range of 18.0 - 30.0 kg/m2.

        Key Exclusion Criteria:

          -  Use of other investigational drugs within 5 half-lives of Screening, or within 30 days
             of dosing, whichever is longer; or longer if required by local regulations.

          -  Significant illness which has not resolved within two (2) weeks prior to initial
             dosing.

          -  Pregnant or nursing (lactating) women.

          -  Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant.

          -  Sexually active males unwilling to use a condom during intercourse while taking
             investigational drug and for at least 2 weeks after last dose of investigational drug.
A Study of Single Dose MK-3614 (MK-3614-001)(COMPLETED)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: MK-3614; Comparator: Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will determine if MK-3614, given as single doses, is safe and well tolerated in
      healthy males and male participants with mild to moderate hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy participants between 18 to 45 years of age; otherwise healthy participants
             between 18 to 55 years of age newly diagnosed with grade 1 or 2 hypertension

          -  Participant is in good general health

          -  Participant is a nonsmoker

        Exclusion Criteria:

          -  Participant has a history of stroke, seizure or major neurological disease

          -  Participant has functional disability that can interfere with rising from a sitting
             position to a standing position

          -  Participant has a family history of a bleeding or clotting disorder

          -  Participant has a history of cancer

          -  Participant is unable to refrain from or anticipates the use of any prescription or
             non-prescription medication during the study

          -  Participant consumes excessive amounts of alcohol or caffeine

          -  Participant has had major surgery, donated blood or participated in another
             investigational study in the past 4 weeks.
A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants
Condition: Healthy Participants
Intervention: Sotorasib
Intervention description: Oral tablet
Intervention MeSH terms: Sotorasib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 145.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Sotorasib; AMG 510; Bioequivalence

Summary:

      The primary objective of this study is to compare the pharmacokinetics (PK) of sotorasib dose
      A administered orally as 3 tablets (test) to sotorasib dose A administered orally as 8
      tablets (reference).
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 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 participant safety
             or interfere with the study evaluation, procedures, or completion.
A Study of LY900014 in Healthy Chinese Participants
Condition: Healthy
Intervention: LY900014; Insulin Lispro
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: Single (Participant)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which
      is a drug that lowers blood sugar. The study will look at how the body processes LY900014 and
      the effect of LY900014 on blood sugar levels. For each participant, the study will consist of
      3 periods and will last about 51 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy native Chinese males or females

          -  Female participants:

               -  Women of child-bearing potential who are abstinent or use effective methods of
                  contraception for the entirety of the study.

               -  Women not of child-bearing potential who are infertile or post-menopausal

          -  Have a body mass index (BMI) of 18 to 28 kilograms per square meter (kg/m²)

          -  Are nonsmokers

          -  Have a fasting plasma glucose value >71 milligrams per deciliter (mg/dL) (3.9
             millimoles per liter [mmol/L]) and <108 mg/dL (6.0 mmol/L)

        Exclusion Criteria:

          -  Are currently enrolled in a clinical study, or have participated, within the last 30
             days, in a clinical study involving an investigational product

          -  Have previously completed or withdrawn from this study or any other study
             investigating LY900014

          -  Have known allergies to LY900014 or any components of the formulation

          -  Have a significant history of cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine, hematological, or neurological disorders capable of
             significantly altering the absorption, metabolism, or elimination of drugs; of
             constituting a risk when taking the investigational product; or of interfering with
             the interpretation of data

          -  Intend to use over-the-counter or prescription medication within 7 and 14 days,
             respectively, prior to dosing or during the study.

          -  Have donated blood of more than 400 milliliters (mL) within the previous 6 months of
             study screening or donated more than 100 mL within the last 30 days.

          -  Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14
             units per week (females)
Safety, Tolerability and Pharmacokinetics of ERX-963 in Adults With Myotonic Dystrophy Type 1
Condition: Myotonic Dystrophy, Type 1 (DM1); Myotonic Dystrophy
MeSH terms: Myotonic Dystrophy
Intervention: ERX-963; Placebo
Intervention description: Active medicine; Comparator
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Excessive Daytime Sleepiness; hypersomnia

Summary:

      Participants in this study will receive two treatments, placebo and ERX-963, on different
      days in a randomized fashion.

      The primary purpose of this study is to investigate the safety and tolerability of ERX-963 in
      participants diagnosed with Myotonic Dystrophy, Type 1 (DM1).

      The secondary purpose is to evaluate the potential of ERX-963 treatment to reduce excessive
      daytime sleepiness / hypersomnia and improve cognitive function in DM1 participants compared
      to placebo treatment.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  18 to 65 years of age

          -  DM1 defined by genetic testing or clinical-confirmation

          -  Epworth Sleepiness Scale (ESS) of > 11 or participants who have long sleep periods of
             an average of > 10 hours a day

          -  Age of onset of DM1 greater than 16 years

        Key Exclusion Criteria:

          -  Significant respiratory compromise

          -  Significant cardiac disease

          -  Diagnosis of symptomatic Restless Leg Syndrome or significant untreated nocturnal
             hypoxias

          -  Significant moderate to severe hepatic insufficiency

          -  Clinically active depression, anxiety, or other medical condition that, in the
             investigator's opinion, would interfere with the safety and efficacy assessments

          -  History of seizures

          -  History of panic disorders
A Study To Evaluate The Effect Of PF-04447943 On Qtc Interval In Healthy Adult Subjects
Condition: Healthy
Intervention: PF-04447943; Placebo; Moxifloxacin
Intervention description: Single oral dose of PF-04447943 administered as an extemporaneously prepared solution; Single oral dose of matching placebo for PF-04447943 administered as an extemporaneously prepared solution; Single oral dose of moxifloxacin administered as tablet
Intervention MeSH terms: Moxifloxacin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a study designed to ascertain the effect of PF-04447943 on QT interval in healthy
      adult subjects. This is conducted as part of standard drug development.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy female subjects of non childbearing potential and/or healthy male subjects,
             between the ages of 18 and 55 years.

          -  Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg.

        Exclusion Criteria:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
             allergic disease (including drug allergies, but excluding untreated, asymptomatic,
             seasonal allergies at the time of dosing).

          -  History of cerebrovascular accident, transient ischemic attack (TIA), or traumatic
             brain injury.

          -  History of seizures or history or physical examination findings (eg localizing signs
             on neurologic examination) suggestive of structural central nervous system (CNS)
             abnormalities which may place patient at increased risk of seizures.

          -  History of orthostatic blood pressure changes or clinically significant orthostatic
             symptoms.

          -  Self reported history or risk factors for QT prolongation or torsades de pointes (eg,
             organic heart disease, congestive heart failure, hypokalemia, hypomagnesaemia,
             congenital long QT syndrome, myocardial ischemia or infarction), congenital deafness,
             family history of sudden death, and family history of long QT syndrome.