A Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Target Engagement of BMS-986147 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BMS-986147; Drug: Placebo matching BMS-986147

• Registration Number: NCT02293629
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

This is the first clinical study with the BMS-986147 compound in healthy subjects. The purpose of this study is to guide the dose range and dose frequency for future studies with BMS-986147 and will provide guidelines for selection of a potentially effective dose in patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Study First Submitted: 2014-11-14
• Study First Submitted QC: 2014-11-17
• Study First Posted: 2014-11-18
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-18
• Last Update Posted: 2015-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Healthy men and women, ages 18 to 45 years
• Subjects must not have clinically significant deviation from normal: medical history, physical examination, ECGs and laboratory evaluations
• Women of child bearing potential are eligible for enrollment.
• Women must have a negative pregnancy test

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Exclusion Criteria

• Evidence of organ dysfunction
• Any significant acute or chronic medical illness
• Inability to: tolerate oral medications, be venipunctured

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
A2: BMS-986147 or Placebo matching BMS-986147	Placebo matching BMS-986147	Single oral dose as specified
A1: BMS-986147 or Placebo matching BMS-986147	BMS-986147	Single oral dose as specified
B1: BMS-986147 or Placebo matching BMS-986147	Placebo matching BMS-986147	Daily oral dose as specified
A2: BMS-986147 or Placebo matching BMS-986147	BMS-986147	Single oral dose as specified
A3: BMS-986147 or Placebo matching BMS-986147	BMS-986147	Single oral dose as specified
A3: BMS-986147 or Placebo matching BMS-986147	Placebo matching BMS-986147	Single oral dose as specified
B2: BMS-986147 or Placebo matching BMS-986147	Placebo matching BMS-986147	Daily oral dose as specified
A1: BMS-986147 or Placebo matching BMS-986147	Placebo matching BMS-986147	Single oral dose as specified
B1: BMS-986147 or Placebo matching BMS-986147	BMS-986147	Daily oral dose as specified
B2: BMS-986147 or Placebo matching BMS-986147	BMS-986147	Daily oral dose as specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of single oral dose of BMS-986147 based on incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, and physical examinations	Up to 30 days post last dose of study drug	Adverse event (AE)
Safety and tolerability of multiple oral dose of BMS-986147 based on incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, and physical examinations	Up to 30 days post last dose of study drug

Trial Locations

Locations (1)

Wcct Global, Llc; 🇺🇸 Cypress, California, United States