bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence of Pramipexole Extended Release (PPX ER) 1.5mg x 1 Tablet Once Daily (q.d.) vs. PPX ER 0.375mg x 4 Tablets Under Fasted and Fed Conditions in Japanese Healthy Volunteers
Condition: Healthy
Intervention: PPX ER; PPX ER
Intervention description: PPX ER 0.375mg - 1.5mg for 32 days totally; PPX ER 0.375mg - 1.5mg for 32 days totally
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: Male
Minimum age: 20 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Bioequivalence between PPX ER 1.5 mg x 1 tablet q.d. and 0.375 mg PPX ER x 4 tablets q.d.
      under fasted and fed conditions Food effect of 1.5 mg ER x 1 tablet q.d.
    

Eligibility criteria:

        Inclusion criteria:

          -  Japanese healthy male

          -  20 to 40 years of age

          -  body mass index (BMI) between 17.6 and 26.4 kg/m2 (BMI calculation: weight in
             kilograms divided by the square of height in meters)

        Exclusion criteria:

          1. Any clinical relevance findings of the medical examination as follows

               1. Blood pressure (systolic blood pressure is lower than 110 mmHg and diastolic
                  blood pressure is lower than 60 mmHg at the screening in either a supine or a
                  sitting position),

               2. pulse rate,

               3. electrocardiogram [ECG]

               4. laboratory test parameters) of clinical relevance

          2. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders

          3. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or
             neurological disorders

          4. History of orthostatic hypotension, fainting spells or blackouts

          5. Chronic or acute infections
Interactions Between Cannabinoids and Cytochrome P450-Metabolized Drugs
Condition: Drug-Interactions
Intervention: Inje cocktail; THC Cannabis extract; THC/CBD Cannabis Extract
Intervention description: Acute drug exposure; Acute drug exposure; Acute drug exposure
Intervention MeSH terms: Dronabinol
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking description: Placebo controlled, double blind
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate drug-drug interactions between cannabis extracts containing
      Tetrahydrocannabinol (THC) and THC+ Cannabinoids (CBD) and probe drugs for select CYP450
      pathways including: caffeine (CYP1A2), omeprazole (CYP2C19), losartan (CYP2C9),
      dextromethorphan (CYP2D6), and midazolam (CYP3A).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult between 18-50 years old

          -  BMI between 18 to 34 kg/m2

          -  Willing to use birth control

          -  Willing to abstain from all medications and citrus fruits for the duration of the
             study

        Exclusion Criteria:

          -  Medical or psychiatric illness judged by the investigator to put the participant at
             greater risk of experiencing an adverse event due to drug exposure or completion of
             other study procedures.

          -  Use of medications which, in the opinion of the investigator or medical staff, will
             interfere with the study outcomes or the safety of the participant.

          -  Clinically significant impairment of kidney, liver, or thyroid function (serum
             creatinine >1.2 mg/ml (kidney), liver function tests >3x the upper limit of normal
             (alanine amino transferase >99 U/L; aspartate amino transferase > 99 U/L), and thyroid
             stimulating hormone > 4.2 uIU/ml), or evidence of current anemia based on blood
             chemistry testing.

          -  History of adverse events associated with the ingestion of cannabis or any medications
             in the Inje cocktail judged by the investigator to present an undue risk of harm to
             the participant.
Study Of Sunitinib Plus FOLFOX In Patients With Solid Tumors
Condition: Colorectal Neoplasms; Neoplasms
MeSH terms: Neoplasms; Colorectal Neoplasms
Intervention: sunitinib + FOLFOX; sunitinib + FOLFOX; sunitinib + FOLFOX; sunitinib + FOLFOX; sunitinib + FOLFOX; sunitinib + FOLFOX; sunitinib + FOLFOX
Intervention description: 37.5 mg sunitinib + modified FOLFOX6 (Schedule 2/2); 50 mg sunitinib + modified FOLFOX6 (Schedule 2/2); 50 mg sunitinib + modified FOLFOX6 ( CRC, only Schedule 2/2); 37.5 mg sunitinib + modified FOLFOX6 (Schedule 4/2); 50 mg sunitinib + modified FOLFOX6 (Schedule 4/2); 37.5 mg sunitinib + modified FOLFOX6 (Continuous Dosing); 25 mg sunitinib + modified FOLFOX6 (Continuous Dosing)
Intervention MeSH terms: Leucovorin; Sunitinib; Fluorouracil; Oxaliplatin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: advanced solid tumors,; colorectal cancer,; sunitinib (SUTENT),; FOLFOX

Summary:

      This study determined the maximum tolerated dose and safety of SU011248 (sunitinib malate,
      SUTENT) in combination with FOLFOX [Leucovorin + Fluorouracil (5-FU) + Oxaliplatin]. Three
      different dosing regimens with starting doses of sunitinib at 37.5 mg/day (Schedule 2/2,
      Schedule 4/2, and Continuous Dosing) were tested in patients with advanced solid tumors,
      including colorectal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced solid tumor malignancy (during expansion at the maximum tolerated dose, entry
             will be limited to patients wtih adenocarcinoma of the colon or rectum)

          -  Eastern Cooperative Oncology Group (ECOG) 0 or 1

        Exclusion Criteria:

          -  Prior treatment with more than 6 cycles of traditional alkylating agent-based
             chemotherapy regimens

          -  Prior treatment with more than 2 cycles of carboplating-based chemotherapy regimens

          -  For colorectal cancer patients in the expanded cohorts, prior treatment with more than
             2 systemic chemotherapy regimens in the metastatic setting
A Bioavailability Study of Nicotine Delivered by an Electronic Vapour Product
Condition: Healthy Volunteers
Intervention: EVP unflavoured; EVP flavoured; Nicotine inhalator; Conventional cigarette
Intervention description: 15 mg nicotine Nicorette
Intervention MeSH terms: Nicotine
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Electronic Vapour Products (EVPs) are a relatively new class of consumer products that are
      otherwise known as electronic cigarettes. These may look like conventional cigarettes but do
      not contain tobacco.

      The 'vapour' produced by such devices typically consists of humectants (propylene glycol or
      glycerol), nicotine, water, and flavours.

      This trial is to evaluate the pharmacokinetic profile of an EVP.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI of 18-35kg/m2

          -  Subjects must be established smokers

          -  Subjects must have smoked five to 30 cigarettes per day for at least one year

        Exclusion Criteria:

          -  Subjects who have used nicotine replacement therapy within 14 days of the screening

          -  Subjects who have donated blood within 12 months preceding study

          -  Subjects with relevant illness history

          -  Subjects positive for hepatitis or HIV

          -  Subjects with history of drug or alcohol abuse

          -  Subjects with lung function test or vital signs considered unsuitable

          -  Subjects who are trying to stop smoking
A Study to Compare Two Different Formulations of Mirikizumab in Healthy Participants
Condition: Healthy
Intervention: Mirikizumab
Intervention description: Reference and test formulations of mirikizumab administered as a SC injection.
Intervention MeSH terms: Mirikizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare two different formulations of mirikizumab in healthy
      participants. This study will compare how much of each formulation gets into the blood stream
      and how long it takes the body to remove it. Information about any side effects that may
      occur will also be collected. Participants will remain in the study for about 12 weeks, after
      receiving study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males or females, as determined through medical history and
             physical examination

        Exclusion Criteria:

          -  Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and
             14 units/week (females)

          -  Must not show evidence of active or latent tuberculosis (TB)

          -  Must not have received live vaccine(s) (including attenuated live vaccines and those
             administered intranasally) within 8 weeks of screening, or intend to during the study

          -  Must not have been treated with steroids within 1 month of screening, or intend to
             during the study

          -  Must not be immunocompromised

          -  Must not have received treatment with biologic agents (e.g. monoclonal antibodies,
             including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior
             to Day 1

          -  Must not have clinically significant multiple or severe drug allergies, or intolerance
             to topical corticosteroids, or severe post treatment hypersensitivity reactions

          -  Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except
             for basal cell or squamous epithelial carcinomas of the skin that have been resected
             with no evidence of metastatic disease for 3 years

          -  Must not have had breast cancer within the past 10 years

          -  Must not have significant allergies to humanized monoclonal antibodies

          -  Must not have clinically significant multiple or severe drug allergies, or intolerance
             to topical corticosteroids, or severe post treatment hypersensitivity reactions
Study to Determine the Safety, Tolerability, and Pharmacokinetic (PK) Profile of EGT0001474 in Healthy Volunteers
Condition: Safety and Tolerability of EGT0001474 in Healthy Volunteers
Intervention: EGT0001474; Placebo
Intervention description: Oral ascending doses given daily as capsules for up to 14 days; Placebo to match EGT0001474
Intervention MeSH terms: Sodium-Glucose Transporter 2 Inhibitors
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diabetes Mellitus Type 2

Summary:

      This study evaluated the safety, tolerability and pharmacokinetics of single or multiple
      doses of EGT0001474.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female volunteers between the ages of 18 and 55 years inclusive.

          -  In good health.

          -  Female subjects must be surgically sterilized or postmenopausal.

          -  Body mass index (BMI) between 18 kg/m2 and 30 kg/m2 inclusive.

          -  Non-smoker.

          -  Negative drug and alcohol screens.

        Exclusion Criteria:

          -  Abnormal ECG

          -  Sitting blood pressure above 140/90 mmHg on 2 evaluations at least 10 minutes apart at
             screening

          -  Treatment with an investigational drug within 30 days or 7 half-lives, whichever is
             longer.

          -  Previous treatment with EGT0001474.

          -  History of drug abuse.

          -  Febrile illness within 5 days prior to the first dose of study medication.
AZD8108 SAD/MAD in Healthy Volunteers
Condition: Healthy Volunteers
Intervention: AZD8108; Placebo
Intervention description: Drug: AZD8108 Single or Multiple doses administered orally as a solution.; Placebo to match AZD8108 Single or Multiple doses of matching placebo administered orally as a solution
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 258.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a randomized, double-blind, placebo-controlled study of single and multiple ascending
      dosage levels of AZD8108 in healthy volunteers. The study includes an up to 28-day screening
      period, an in-house period during which AZD8108 or placebo will be administered orally as a
      solution, and a 4- to 10-day follow-up period after discharge.
    

Eligibility criteria:

        Inclusion Criteria: Inclusion Criteria: 1. Subjects must understand the nature of the study
        and must provide signed and dated written informed consent in accordance with local
        regulations before the conduct of any study-specific procedures. 2. Men and postmenopausal
        or surgically sterile women age 18-55 years inclusive. 3. Subjects must have a body mass
        index (BMI) between 19 and 30, inclusive and weigh between 50kg and 100kg inclusive.
        4.Subjects must be fluent in English.

        -

        Exclusion Criteria:1. A history or presence of a clinically significant hepatic, renal,
        gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic,
        dermatologic, or neurologic abnormality. 2. A clinically significant abnormality on
        physical examination, neurological examination, EEG, ECG, vital signs or laboratory
        evaluations at screen or between screen and dose administration. 3. A history of seizure.
        4.A history of head trauma, including closed head injury with loss of consciousness. 5.Any
        history of suicide attempt or suicidal behavior, or, in the opinion of the investigator,
        clinically significant risk of suicide or violent behavior. 6. Urine drug screen positive
        for a drug of abuse 7. A family history of schizophrenia, schizoaffective disorder, or
        psychosis in first degree relatives.
RDEA3170 Bioavailability Study
Condition: Gout
Intervention: RDEA3170 10 mg; RDEA3170 2.5 mg
Intervention MeSH terms: Verinurad
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 1, randomized, open-label, 4-way crossover pharmacokinetic (PK) and
      pharmacodynamic (PD) study in healthy adult male subjects designed to assess the relative
      bioavailability of RDEA3170 2.5 mg tablets administered as a 10 mg dose (2.5 mg × 4 tablets)
      and of a single RDEA3170 10 mg tablet. This study will also assess the effect of a low-fat
      and high-fat meal on the PK and PD of RDEA3170 10 mg tablets.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is able to understand the study procedures and the risks involved and is
             willing to provide written informed consent before the first study-related activity

          -  Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2

          -  Subject has a Screening serum urate level ≤ 7 mg/dL

          -  Subject is free of any clinically significant disease or medical condition, per the
             Investigator's judgment

        Exclusion Criteria:

          -  Subject has a history or suspicion of kidney stones

          -  Subject has undergone major surgery within 3 months prior to Screening

          -  Subject donated blood or experienced significant blood loss (> 450 mL) within 12 weeks
             prior to Day 1 or gave a plasma donation within 4 weeks prior to Day 1

          -  Subject has inadequate venous access or unsuitable veins for repeated venipuncture

          -  Subject has a Screening serum creatinine value above the upper limit of normal during
             Screening or at Day -2 (Admission)

          -  Subject cannot swallow multiple tablets

          -  Subject is a heavy caffeine drinker

          -  Subject is unwilling to comply with the dietary restrictions of the study

          -  Subject is unable or unwilling to comply with the study requirements or has a
             situation or condition that, in the opinion of the Investigator, may interfere with
             participation in the study
A Dose-escalating Clinical Trial With KH176
Condition: MELAS; LHON; Leigh Syndrome; Mitochondrial Disease; Mitochondrial DNA tRNALeu(UUR) m.3243A<G Mutation
MeSH terms: Leigh Disease; Mitochondrial Diseases
Intervention: KH176; placebo
Intervention MeSH terms: 6-hydroxy-2,5,7,8-tetramethylchroman-2-carboxylic acid
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 32.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Mitochondrial Diseases are rare progressive, multi-system, often early fatal disorders
      affecting both children and adults. KH176 is a novel chemical entity currently under
      development for the treatment of inherited mitochondrial diseases, including MELAS
      (Mitochondrial Encephalomyopathy, Lactic acidosis, and Stroke-like episodes), Leigh's Disease
      and Leber's Hereditary Optic Neuropathy (LHON). KH176 is a potent intracellular redox
      modulating agent targeting the reactive oxygen species which are important in the
      pathogenesis of disorders of mitochondrial oxidative phosphorylation. After demonstrating a
      favourable safety profile in the pre-clinical testing, the safety, tolerability and
      pharmacokinetic and pharmacodynamic characteristics of the compound will now be evaluated in
      healthy male subjects in this trial
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy as assessed by medical history, physical examination, Vital Signs, Clinical
             Laboratory, ECG

        Exclusion Criteria:

          -  Allergies,

          -  Concomitant medication,

          -  concomitant disease,

          -  relevant surgery,

          -  recent blood donation
Trial of MSC1936369B in Subjects With Solid Tumors
Condition: Solid Tumors; Cancer
MeSH terms: Neoplasms
Intervention: MSC1936369B; MSC1936369B; MSC1936369B; MSC1936369B
Intervention MeSH terms: Niacinamide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 182.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: MEK inhibitor; Cancer; Solid tumors

Summary:

      This is a first in man trial with a primary objective being the determination of the Maximum
      Tolerated dose (MTD) and the dose-limiting toxicity (DLT) in several regimens of MEK
      inhibitor MSC1936369B administered orally once a day, in subjects with malignant solid tumors
      to see how safe is treatment with MSC1936369B.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically-confirmed solid tumor which is locally advanced or metastatic, and
             either refractory after standard therapy for the disease or for which no effective
             standard therapy is available. In the regimen 3, regimen 2 food-effect, and BID
             cohorts, the tumor type will be restricted to melanoma.

          -  Age greater than or equal to (>=) 18 years

          -  Has read and understands the informed consent form and is willing and able to give
             informed consent. Fully understands requirements of the trial and willing to comply
             with all trial visits and assessments

        Exclusion Criteria:

          -  Bone marrow impairment as evidenced by Haemoglobin less than (<) 9.0 gram per
             deciliter (g/dL), Neutrophil count < 1.0*10^9/Liter, platelets < 100*10^9/Liter

          -  Renal impairment as evidenced by serum creatinine > 1.5*upper limit normal (ULN),
             and/or calculated creatinine clearance < 60 milliliter per minute (mL/min)

          -  Liver function abnormality as defined by total bilirubin > 1.5*ULN, or aspartate
             aminotransferase (AST)/alanine aminotransferase (ALT) > 2.5*ULN, for subjects with
             liver involvement AST/ALT > 5*ULN

          -  INR > 1.5*ULN

          -  Serum calcium > 1*ULN

          -  History of central nervous system (CNS) metastases, unless subject has been previously
             treated for CNS metastases, is stable by computer tomography (CT) scan without
             evidence of cerebral oedema, and has no requirements for corticosteroids or
             anticonvulsants

          -  History of difficulty swallowing, malabsorption or other chronic gastro-intestinal
             disease or conditions that may hamper compliance and/or absorption of the tested
             product

          -  Eastern Cooperative Oncology Group Performance status (ECOG PS) greater than (>) 1

          -  Known human immunodeficiency virus (HIV) positivity, active hepatitis C, or active
             hepatitis B