A Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Target Engagement of BMS-986147 in Healthy Subjects
A Randomized, Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Target Engagement of BMS-986147 in Healthy Subjects
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Oct 2014
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 14, 2014
CompletedFirst Posted
Study publicly available on registry
November 18, 2014
CompletedMay 19, 2015
May 1, 2015
1 month
November 14, 2014
May 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Adverse event (AE)
Up to 30 days post last dose of study drug
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
Study Arms (5)
A1: BMS-986147 or Placebo matching BMS-986147
PLACEBO COMPARATORSingle oral dose as specified
A2: BMS-986147 or Placebo matching BMS-986147
PLACEBO COMPARATORSingle oral dose as specified
A3: BMS-986147 or Placebo matching BMS-986147
PLACEBO COMPARATORSingle oral dose as specified
B1: BMS-986147 or Placebo matching BMS-986147
ACTIVE COMPARATORDaily oral dose as specified
B2: BMS-986147 or Placebo matching BMS-986147
ACTIVE COMPARATORDaily oral dose as specified
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Evidence of organ dysfunction
- Any significant acute or chronic medical illness
- Inability to: tolerate oral medications, be venipunctured
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wcct Global, Llc
Cypress, California, 90630, United States
Related Links
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2014
First Posted
November 18, 2014
Study Start
October 1, 2014
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
May 19, 2015
Record last verified: 2015-05