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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: BMS-986318; Other: Placebo

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

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • PRA Health Sciences - Lenexa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Monotherapy SAD BMS-986318 or Placebo; Single Ascending Dose (SAD)	Drug: BMS-986318; Specified dose on specified days; Other: Placebo; Placebo Matching BMS-986318
EXPERIMENTAL: Monotherapy MAD BMS-986318 or Placebo; Multiple Ascending Dose (MAD)	Drug: BMS-986318; Specified dose on specified days; Other: Placebo; Placebo Matching BMS-986318

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 18, 2019
• Primary Completion (ACTUAL): September 12, 2019
• Study Completion (ACTUAL): September 12, 2019

Study Registration Dates

• First Submitted: August 15, 2019
• First Submitted That Met QC Criteria: September 5, 2019
• First Posted (ACTUAL): September 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 24, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IM031-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No