bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of Oral Suspension and Intravenous Formulation of Edaravone in Healthy Adult Subjects
Condition: Healthy Adult Subjects
Intervention: MT-1186; MCI-186
Intervention description: Oral suspension; Intravenous formulation
Intervention MeSH terms: Edaravone
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To evaluate the single-dose bioequivalence of oral suspension and intravenous (IV)
      formulation of edaravone in the fasting state in healthy adult subjects
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult male or female volunteers

          -  Japanese

          -  Subjects aged between 20 and 45 years at the time of informed consent

          -  Subjects who have thoroughly understood the contents of the study and voluntarily
             provided written informed consent to participate in the study

        Exclusion Criteria: Additional screening criteria check may apply for qualification:

          -  Subjects with a current or previous history of cardiac, hepatic, renal,
             gastrointestinal, respiratory, psychiatric/nervous, hematopoietic, or endocrine
             diseases, and those whom the investigator (or subinvestigator) deems unsuitable for
             the study

          -  Body mass index (BMI) of <18.0 or >30.0, or body weight of <50 kg (BMI formula: body
             weight [kg]/height [m]2, rounded to one decimal place)

          -  Subjects who have undergone any surgery known to affect the gastrointestinal
             absorption of drugs

          -  Female subjects who do not agree to use an effective method of contraception from
             screening or 2 weeks before the start of investigational product administration,
             whichever comes earlier, to 14 days after the completion (or discontinuation) of
             investigational product administration. Male subjects who do not agree to use an
             effective method of contraception from the start of investigational product
             administration to 14 days after the completion (or discontinuation) of investigational
             product administration

          -  Subjects who have previously received edaravone

          -  Subjects who have participated in another clinical study and received an
             investigational product within 12 weeks before providing informed consent
A Study of Infusion Site Pain After Infusion of Excipients in Participants With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Sodium Citrate; Treprostinil; Humalog diluent; Magnesium Chloride
Intervention description: Administered SC infusion.; Administered SC infusion.; Administered SC infusion.; Administered SC infusion.
Intervention MeSH terms: Insulin Lispro; Treprostinil; Citric Acid; Sodium Citrate
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: Humalog - Insulin lispro; Citrate; Infusion Site Pain; Excipients

Summary:

      The main purpose of this study is to evaluate the effect of excipients sodium citrate and
      treprostinil without insulin on local infusion site pain in participants with type 1 diabetes
      mellitus (T1DM) on continuous subcutaneous insulin infusion (CSII). The study may last up to
      36 days including a screening period and 3 visits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  T1D for at least 1 year and continuously using insulin for at least 1 year

          -  Using an insulin pump for at least the last 6 months

          -  Have hemoglobin A1c (HbA1c) value of ≤ 9.0%

          -  Have a body mass index (BMI) within the range of 18.5 to 35.0 kilograms per square
             meter (kg/m²)

          -  Have medical and laboratory test results that are acceptable for the study

          -  Have venous access sufficient to allow for blood sampling

        Exclusion Criteria:

          -  Hemophilia or any other bleeding disorder

          -  Have a pathologic tuning fork test as assessed with a Rydel-Seiffer tuning fork

          -  Are taking anesthetics or pain medication regularly or intermittently which could
             interfere with interpretation of pain scale

          -  Have had more than 1 episode of severe hypoglycemia (defined as requiring assistance
             due to neurologically disabling hypoglycemia) within the last 90 days prior to
             screening

          -  Have had more than 1 emergency room visit or hospitalization due to poor glucose
             control (hyperglycemia or diabetic ketoacidosis) within the last 6 months prior to
             screening

          -  Have any hypersensitivity or allergy to any of the diluents or excipients used in this
             trial

          -  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

          -  Have participated, within the last 30 days, in a clinical trial involving an
             investigational product

          -  Have used or are currently using Lyumjev® as part of their standard insulin therapy
Bioavailability Study of Enoxaparin Sodium Chemi and Clexane s.c.
Condition: Enoxaparin Sodium is Administered to Healthy Volunteers
Intervention: Enoxaparin Sodium; Enoxaparin Sodium
Intervention description: comparison of bioavailability of generic Enoxaparin Sodium and Clexane; comparison of bioavailability of generic Enoxaparin Sodium and Clexane
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      -  The primary objective of the trial is to assess the single-dose relative bioavailability
           of Chemi Enoxaparin (80 mg/0.8 mL) and Clexane® (80 mg/0.8 mL) administered by
           subcutaneous (s.c.) injection, under fasting conditions in healthy volunteers.

        -  The secondary objective of the trial is to assess safety and tolerability of Chemi
           Enoxaparin (80 mg/0.8 mL) and Clexane® (80 mg/0.8 mL) administered by s.c. injection,
           under fasting conditions in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or female volunteer between 18 and 55 years of age.

          -  Subject with a BMI of 18-30 (Body Mass Index = Body weight (kg) / [Height (m)]2)

          -  Subject with no clinically significant abnormal serum biochemistry, haematology,
             coagulation factors and urine examination values within 14 days of the first dose.

          -  Subject with no clinically significant abnormalities in 12-lead electrocardiogram
             (ECG) and vital signs determined within 14 days of the first dose.

          -  Subject with negative human immunodeficiency virus (HIV) and hepatitis B surface
             antigen (HbsAg) and hepatitis C virus antibody (HCV) results.

        Exclusion Criteria:

          -  Subject with hypersensitivity or idiosyncratic reaction to enoxaparin and/or low
             molecular weight heparins, and/or pork products.

          -  Subject with a relevant history or presence of significant cardiovascular, pulmonary,
             hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic,
             neurologic, or psychiatric disease. Or with history or presence of alcoholism or drug
             abuse;

          -  Subject with clinically relevant abnormal physical findings or clinically relevant
             abnormal laboratory values indicative of physical illness;

          -  Female subject who is pregnant or lactating

          -  Female subject with weight < 45 kg or male subject with weight < 57 kg.
To Evaluate the Blockade of CGRP in Preventing PACAP-38 Induced Migraine-like Attacks With AMG 334 in Migraine Patients
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Erenumab; Placebo; PACAP-38 Challenge Agent
Intervention description: Administered once on day 1 of Part B of the study by intravenous infusion.; Administered once on day 1 of Part B of the study by intravenous infusion.; Administered by intravenous infusion during Part A of the study for dose selection for Part B.
Administered by intravenous infusion on day 8 in Part B as a challenge agent to induce a migraine-like attack.
Intervention MeSH terms: Pituitary Adenylate Cyclase-Activating Polypeptide; Erenumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Migraine; Headache; Migraine Headache; Headache, Migraine; Amgen

Summary:

      Phase I, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Single Dose Study to
      Evaluate the Blockade of CGRP Receptor by AMG 334 in Preventing PACAP-38 Induced
      Migraine-like Attacks in Migraine Patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults ≥ 18 to ≤ 45 years of age upon entry into screening

          -  History of migraine headaches without aura for ≥ 6 months prior to screening according
             to the International Headache Society (IHS) International Classification of Headache
             Disorders (ICHD-II) (Headache Classification Committee of the International Headache
             Society, 2004) based on medical records and/or patient self-report

          -  Migraine frequency: ≥ 1 and ≤ 5 migraine days per month in each of the 3 months prior
             to screening

        Exclusion Criteria:

          -  History of migraine with aura, cluster headache or hemiplegic migraine headache
             according to the IHS Classification ICHD-II (Headache Classification Committee of the
             International Headache Society, 2004) based on medical records and/or patient
             self-report

          -  ≥ 6 migraine days per month in the last 3 months prior to study enrollment and during
             screening period

          -  Other headache disorders (except for episodic tension-type headache <5 days/month)
A Phase 1, First Time in Human (FTIH) Study to Evaluate GSK3352589, a REarranged During Transfection (RET) Growth Factor Receptor Tyrosine Kinase Inhibitor, in Healthy Volunteers
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome
Intervention: GSK3352589; Matching Placebo
Intervention description: It will be available in the dose of 1, 5, 25 and 100 mg tablet for oral administration.; It will be available across all strengths to match active drug in the form of tablet for oral administration.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: REarranged during Transfection

Summary:

      This FTIH study is designed to assess the safety, tolerability and pharmacokinetic (PK) of
      escalating single and repeat oral doses of GSK3352589 in normal healthy volunteers. This is a
      randomized, double-blind (sponsor unblinded), placebo controlled, dose escalation study that
      will have two parts; Part A and Part B.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between 18 and 55 years of age inclusive, at the time of signing the informed consent.

          -  Healthy as determined by the investigator based on a medical evaluation including
             medical history, physical examination, laboratory tests and cardiac monitoring. -
             History of regular bowel habits

          -  Male or Female of non-childbearing potential.

          -  Capable of giving signed informed consent which includes compliance with the
             requirements and restrictions.

        Exclusion Criteria:

          -  ALT and bilirubin >1.5 x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is
             acceptable if bilirubin is fractionated and direct bilirubin <35%).

          -  Previous Diagnosis of IBS

          -  Estimated Glomerular Filtration Rate <60 millilter per minute per 1.73 square meter
             (mL/min/1.73m^2)

          -  Current or chronic history of liver disease, or known hepatic or biliary abnormalities
             (with the exception of Gilbert's syndrome or asymptomatic gallstones)

          -  History of Gastroesophageal reflux disease (GERD), dyspepsia, Gastrointestinal (GI)
             bleeding, diverticulitis, diverticular stricture or other intestinal strictures, GI
             surgery that could affect motility

          -  Unwillingness or inability to follow the procedures outlined in the protocol
A Dose-finding Study of Dalotuzumab in Subjects With Advanced Solid Tumors (MK-0646-002)
Condition: Advanced Solid Tumors
Intervention: dalotuzumab
Intervention description: Administered as an IV infusion over one to two hours
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study determined the recommended Phase 2 loading and maintenance doses and dose schedules
      for administering dalotuzumab using dose-limiting toxicities (DLTs) observed during the
      entire treatment period (Up to 18 months). The primary hypothesis of the study was that
      administration of dalotuzumab as an every other week infusion in participants with relapsed
      or refractory locally advanced or metastatic cancers associated with a high frequency of
      insulin-like growth factor receptor type 1(IGF-1R) overexpression will be generally safe and
      well tolerated to permit further study and achieve a constant clearance and a minimum trough
      concentration of 3 µg/mL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females with advanced solid tumors who have failed to respond to standard
             therapy, ages 18 years and older, with adequate organ function

        Exclusion Criteria:

          -  Participant is using growth hormones or growth hormone inhibitors

          -  Participant is known to be allergic to components of the drug or similar drugs (e.g.
             monoclonal antibodies such as rituximab or biological therapies such as immunoglobulin
             G

          -  Participant has had chemotherapy, radiotherapy, or biological therapy within 4-6 weeks
             of entering the study or has not recovered from previous therapy

          -  Participant is taking part in or has taken part in a study of an investigational
             compound or device within 30 days of their first dose of study drug

          -  Participant has an active Central Nervous System metastases and/or carcinomatous
             meningitis. However, a participant who has completed a course of therapy and is
             clinically stable may be able to participate

          -  Participant is pregnant or breastfeeding

          -  Participant is human immunodeficiency virus (HIV) positive

          -  Participant has a history of Hepatitis B or C

          -  Participant has symptomatic ascites or pleural effusion. However, if the participant
             has received treatment and is stable, they may be able to participate

          -  Female participant plans to become pregnant or a male participant who plans to
             impregnate their partner during the time the study is ongoing
Insulin Tolerance Test Study in Patients With Type 1 Diabetes
Condition: Type 1 Diabetes; Hypoglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Intervention: Pitolisant
Intervention description: Pitolisant will be administered orally for 7 days. Patients may have their study drug dose adjusted downward if the starting dose is not tolerated.
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: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to determine the safety, tolerability and
      pharmacodynamics of pitolisant in patients with Type 1 Diabetes
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inclusion criteria: Diagnosis of diabetes => 4yrs, On Insulin => 4yrs, HbA1c<= 10%, At
             least one episode of severe hypoglycemia in past 12 months, fasting c-peptide <0.7
             ng/ml

        Exclusion Criteria:

          -  Hypoglycemia unawareness, DKA within 3 months prior to randomization, Reduced renal
             function, Anxiety and depression
A Study of [14 C]-Pevonedistat in Participants With Advanced Solid Tumors
Condition: Advanced Solid Tumors, Neoplasms, Advanced Solid
MeSH terms: Neoplasms
Intervention: Pevonedistat; [14C]-Pevonedistat; Docetaxel; Carboplatin; Paclitaxel
Intervention description: Pevonedistat intravenous infusion.; [14C]-Pevonedistat intravenous infusion.; Docetaxel intravenous infusion.; Carboplatin intravenous infusion.; Paclitaxel intravenous infusion.
Intervention MeSH terms: Paclitaxel; Docetaxel; Carboplatin; Pevonedistat
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      The purpose of this study is to assess the mass balance (that is, cumulative excretion of
      total radioactivity [TRA] in urine and feces) and to characterize the pharmacokinetics (PK)
      of pevonedistat in whole blood, plasma, and urine, and of TRA in plasma and whole blood
      following a single 1-hour infusion of 25 milligram per square meter (mg/m^2)
      [14C]-pevonedistat intravenous (IV) solution containing approximately 60 to 85 microcurie
      (mCi) (approximately 2.22-3.145 megabecquerel [MBq]) of TRA in participants with advanced
      solid tumors in Part A.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have a histologically or cytologically confirmed metastatic or locally advanced and
             incurable solid tumor that is felt to be appropriate for treatment with one of the 2
             chemotherapy regimens in Part B of this study (carboplatin+paclitaxel or docetaxel),
             or have progressed despite prior standard therapy, or for whom conventional therapy is
             not considered effective. The tumor must be radiographically or clinically evaluable
             and/or measurable.

          2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

          3. Expected survival longer than 3 months from enrollment in the study.

          4. Recovered (that is, less than or equal to [<=] Grade 1 toxicity) from the effects of
             prior antineoplastic therapy.

        Exclusion Criteria:

          1. Has irregular defecation patterns (less than 1 defecation per 2 days or excessive
             diarrhea) and/or has a history of changes in bowel habits with daily routine or
             environment changes.

          2. Prior treatment with radiation therapy involving greater than or equal to (>=) 25% of
             the hematopoietically active bone marrow.
Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Leucostim® Compared to Neupogen®
Condition: Leucocytosis
MeSH terms: Leukocytosis
Intervention: Leucostim®; Neupogen®
Intervention description: Leucostim® is filgrastim biosimilar.
Intervention MeSH terms: Lenograstim
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: neutrophil count; filgrastim; granulocyte colony-stimulating factor

Summary:

      BCD-002-1 is 1 phase clinical trial to evaluate pharmacokinetics, pharmacodynamics and safety
      of single-injection of Leucostim® to healthy volunteers compared to Neupogen®
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent.

          -  Male gender.

          -  Age between 18 and 45 years.

          -  Normal body mass index.

          -  Verified diagnosis "healthy", established according to the anamnesis, physical
             examination and laboratory findings.

          -  Absence of alcohol or drug abuse.

        Exclusion Criteria:

          -  History of use of filgrastim.

          -  Allergy to any components of study drugs.

          -  Acute hemorrhage, donation of blood / plasma or blood transfusions during last 2
             months prior to enrollment in the study, history of chronic bleeding.

          -  Surgical interventions during last 30 days prior to screening or planed surgical
             intervention during the study.

          -  Any diseases that could interfere with pharmacokinetics of filgrastim, including
             chronic liver, liver or blood diseases, diseases of cardiovascular, lung and
             neuroendocrine systems.

          -  Fever with body temperature higher than 40°С.