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

Bristol-Myers Squibb (BMS)

Status and phase: Withdrawn; Phase 1

Conditions: Healthy Participants

Treatments: Drug: BMS-986318; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04082741

IM031-002

Details and patient eligibility

About

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

Full 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

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Monotherapy SAD BMS-986318 or Placebo

Experimental group

Description:

Single Ascending Dose (SAD)

Treatment:

Drug: BMS-986318

Other: Placebo

Monotherapy MAD BMS-986318 or Placebo

Experimental group

Description:

Multiple Ascending Dose (MAD)

Treatment:

Drug: BMS-986318

Other: Placebo