idiopathic pulmonary fibrosis idiopathic pulmonary fibrosis
Conditions
Interventions
Part A:
If the volunteer participate in Groups A1 to A5, the volunteer will be given
BMS-986337 or placebo once as a drink with a small volume (between 10 and 30
mL, this is dependent on the dose).
Sponsors
Bristol-Myers Squibb Research and Development
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 ethnically Japanese). 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 female] × 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 treatment. 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 successful vasectomy, during the study treatment period and for at least 5 days after the last dose of study treatment. vi) Female partners of males participating in the study should be advised to use highly effective methods of contraception during the study treatment period and for at least 5 days after the last dose of stu
Exclusion criteria
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 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 Section 6.7. c) Use of any prescription drugs or over-the-counter (OTC) gastric acid controllers within 4 weeks prior to study treatment administration except those medications cleared by the investigator and PRA Medical Monitor. d) Use of any OTC medications and herbal preparations within 2 weeks prior to study treatment administration (except
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation Results of clinical laboratory values, vital signs, electrocardiograms (ECGs), physical examinations | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentrations of BMS-986337, and its acylglucuronide (BMT-405951) and amine (BMT-385617) metabolites; derived PK parameters as applicable Plasma concentrations of BMS-986337, and its BMT-405951 and BMT-385617 metabolites, following a high-fat meal and pH modulation; derived PK parameters as applicable Plasma concentrations of BMS-986337, and its BMT-405951 and BMT-385617 metabolites in Japanese and non- Japanese participants; derived PK parameters as applicable | — |
Countries
Netherlands
Outcome results
None listed