A Single and Multiple Ascending Dose Study of BMS-986318 in Healthy Participants

Study Overview
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Brief Summary
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A study to evaluate single and multiple ascending doses of experimental medicine BMS-986318 in healthy participants.

Detailed Description
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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

Official Title
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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

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986318
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monotherapy SAD BMS-986318 or Placebo<br>Single Ascending Dose (SAD) | Drug: BMS-986318<br>* Specified dose on specified days<br>Other: Placebo<br>* Placebo Matching BMS-986318<br>|
| Experimental: Monotherapy MAD BMS-986318 or Placebo<br>Multiple Ascending Dose (MAD) | Drug: BMS-986318<br>* Specified dose on specified days<br>Other: Placebo<br>* Placebo Matching BMS-986318<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |