Healthy Participants
Conditions
Brief summary
A study to evaluate single and multiple ascending doses of experimental medicine BMS-986318 in healthy participants.
Detailed description
A Phase 1, Double-Blind, Placebo-Controlled, Randomized Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of Oral BMS-986318 Administration in Healthy Participants
Interventions
DRUGBMS-986318
Specified dose on specified days
OTHERPlacebo
Placebo Matching BMS-986318
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Participants as determined by no clinically significant deviations from normal in medical history, physical examination, ECG and clinical laboratory results as determined by the investigator * Male participants who are sexually active with Women of Child Bearing Potential (WOCBP) must agree to follow instructions for methods of contraception for duration of treatment plus 92 days. * Female participants must have documented proof that they are not of childbearing potential and a negative pregnancy test at screening and within 24 hours before the first dose of study treatment.
Exclusion criteria
* Use of any prescription drugs within 4 weeks or use of over-the-counter (OTC) medications or herbal preparations within 2 weeks prior to study treatment administration (except acid controllers, which are not allowed within 4 weeks prior to study treatment administration * Women of Child Bearing Potential (WOCBP) or women who are breastfeeding. * Any major surgery within 12 weeks of study administration Or any history of GI surgeries as listed.(eg, gastric bypass, gastric banding, Roux-en-Y) or gastric- emptying issues that could impact upon the absorption of nutrients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of non-serious adverse events (AEs) | up to 30 days |
| Incidence of Serious Adverse Events (SAE) | up to 30 days |
| Incidence of AEs leading to discontinuation of study treatment | up to 30 days |
| Physical Examination of height | up to 30 days |
| Physical Examination of weight | up to 30 days |
| Physical Examination of BMI | up to 30 days |
| Assessment of body temperature | up to 30 days |
| Assessment of respiratory rate | up to 30 days |
| Assessment of blood pressure | up to 30 days |
| Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities | up to 30 days |
| Number of clinical significant changes in lab assessment of blood serum | up to 30 days |
| Number of Clinically significant changes in assessment of blood | up to 30 days |
| Number of Clinically significant changes in lab assessment of urine | up to 30 days |
Countries
United States
Outcome results
None listed