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Clinical Trials/NL-OMON49565
NL-OMON49565CompletedNot Applicable

A double-blind, placebo-controlled, randomized, single and multiple ascending dose study of the safety and tolerability, and pharmacokinetics (including food effect, pH effect and Japanese bridging study) of BMS-986337 following oral administration in healthy participants - FIH study with LPA1#3

Bristol-Myers Squibb Research and Development0 sites78 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
78
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • •1) Signed Written Informed Consent
  • •a) Participants must be willing and able to participate in the study and sign
  • •the informed
  • •consent form (ICF).
  • •b) Participants must be willing and able to complete all study-specific
  • •procedures and visits.
  • •2) Type of Participant and Target Disease Characteristics
  • •a) Healthy participant, as determined by no clinically significant deviation
  • •from normal in
  • •medical history, physical examination, ECGs, and clinical laboratory
  • •determinations.
  • •b) Participants in the Japanese cohorts in Part C must be first-generation
  • •Japanese (born in
  • •Japan, not living outside of Japan for more than 10 years, and both parents are
  • •c) Body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2, inclusive, at screening.
  • •BMI = weight (kg)/height (m)2
  • •d) Body weight between 50 kg and 120 kg, inclusive, at screening.
  • •e) Normal renal function at screening (and study admission) as evidenced by an
  • •estimated glomerular filtration rate (eGFR) >= 80 mL/min/1.732 m2 calculated
  • •with the Chronic Kidney Disease Epidemiology Collaboration formula.
  • •GFR = 141 × (min(SCr/*,1)a × max (SCr/*,1) -1.209 × 0.993Age × 1.018 [if
  • •1.159 [if black]) Where SCr is serum creatinine (mg/dL), * is 0.7 for females
  • •and 0.9 for males, a
  • •is -0.329 for females and -0.411 for males, min indicates the minimum of SCr/*
  • •or 1, and max indicates the maximum of SCr/* or 1.
  • •3) Age and Reproductive Status
  • •a) Female Participants:
  • •i) Females, ages 21 to 65 years, inclusive.
  • •ii) Women participants must have documented proof that they are not of
  • •childbearing potential (refer to APPENDIX 4).
  • •iii) A female participant is eligible to participate if she is not pregnant or
  • •breastfeeding, and is not a WOCBP.
  • •iv) Women who are not of childbearing potential are exempt from contraceptive
  • •requirements.
  • •b) Male Participants:
  • •i) Males, ages 21 to 65 years, inclusive.
  • •ii) Males who are sexually active with WOCBP must agree to follow instructions
  • •for method(s) of contraception defined in APPENDIX 4 and as described below.
  • •iii) Azoospermic males are not exempt from contraceptive requirements and will
  • •be required to always use a latex or other synthetic condom during any sexual
  • •activity (eg, vaginal, anal, oral) with WOCBP even if the participant has
  • •undergone a successful vasectomy or if the partner is pregnant.
  • •iv) Male participants will be required to always use a latex or other synthetic
  • •condom during any sexual activity (eg, vaginal, anal, oral) with WOCBP; even if
  • •the participants have undergone a successful vasectomy or if their partner is
  • •already pregnant or breastfeeding. Males should continue to use a condom during
  • •the study treatment period and for at least 5 days after the last dose of study
  • •v) Male participants with a pregnant or breastfeeding partner must agree to
  • •remain abstinent from sexual activity or use a male condom during any sexual
  • •activity (eg, vaginal, anal, oral) even if the participants have undergone a
  • +5 more not shown

Exclusion Criteria

  • •1) Medical Conditions
  • •a) Women who are of childbearing potential.
  • •b) Women who are breastfeeding.
  • •c) Any significant acute or chronic medical condition that presents a potential
  • •risk to the participant and/or that may compromise the objectives of the study,
  • •including active, or history of, liver disease, or intestinal disorder
  • •including irritable bowel syndrome.
  • •d) History or presence of malignancy including hematological malignancies;
  • •participants with a history of basal cell or squamous cell carcinoma that has
  • •been treated with no evidence of recurrence within 5 years will be allowed for
  • •inclusion, as judged by the investigator.
  • •e) History of significant cardiac disease (eg, hospitalization for congestive
  • •heart failure, myocardial infarction, unstable angina, coronary angioplasty, or
  • •coronary artery bypass graft within 6 months of screening) or uncontrolled
  • •atrial or ventricular cardiac arrhythmias.
  • •f) History of significant left ventricular dysfunction (ie, echocardiography
  • •with ejection fraction of < 40%).
  • •g) Current or recent (within 3 months of study treatment administration)
  • •gastrointestinal disease that could impact upon the absorption of study
  • •h) Any major surgery within 6 weeks of study treatment administration.
  • •i) Any gastrointestinal surgery, including cholecystectomy, that, in the
  • •opinion of the investigator, could impact upon the absorption of study
  • •j) Documented congenital QT syndrome, and/or corrected QT-interval (Fridericia
  • •correction,
  • •QTcF) at screening or first admission > 450 msec.
  • •k) Donation or loss of more than 450 mL of blood within 2 months prior to (the
  • •first) study
  • •treatment administration.
  • •l) Blood transfusion within 4 weeks of study treatment administration.
  • •m) Inability to tolerate oral medication.
  • •n) Inability to be venipunctured and/or tolerate venous access.
  • •o) Participants who have smoked or used smoking cessation or
  • •nicotine-containing products
  • •(including, but not limited, to e-cigarettes, pipes, cigars, chewing tobacco,
  • •nicotine patches,
  • •nicotine lozenges, or nicotine gum, varenicline, bupropion) within 3 months of
  • •the first dose of study treatment.
  • •p) Recent (within 6 months of study treatment administration) drug or alcohol
  • •abuse as defined in Diagnostic and Statistical Manual of Mental Disorders 4th
  • •edition (DSM-IV),13 Diagnostic Criteria for Drug and Alcohol Abuse.
  • •q) Average intake of more than 21 units of alcohol (1 unit of alcohol equals
  • •approximately 12 oz of beer, 5 oz of wine, or 1.5 oz of spirits) per week
  • •within the last 6 months at the screening visit. After screening, participants
  • •are permitted to consume an average intake of <= 14 units of alcohol per week
  • •until the day of study admission.
  • •r) Any other medical, psychiatric, and/or social reason as determined by the
  • •investigator.
  • •2) Prior/Concomitant Therapy
  • •a) Prior exposure to BMS-986278.
  • •b) Inability to comply with restrictions and prohibited treatments as listed in
  • +7 more not shown

Investigators

Sponsor
Bristol-Myers Squibb Research and Development

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