NL-OMON49565已完成不适用
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 个研究点目标入组 78 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
- 另有 5 项未显示
排除标准
- •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
- 另有 7 项未显示
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