Safety and Tolerability Study of BMS-986177 in Healthy Subjects
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of BMS-986177 in Healthy Subjects
2 other identifiers
interventional
104
1 country
1
Brief Summary
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of BMS-986177 in healthy subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2015
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
First Submitted
Initial submission to the registry
November 17, 2015
CompletedFirst Posted
Study publicly available on registry
November 20, 2015
CompletedStudy Start
First participant enrolled
December 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 23, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 23, 2017
CompletedJuly 31, 2017
July 1, 2017
1.6 years
November 17, 2015
July 27, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
Safety of single dose of BMS-986177 measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Adverse event (AE), Serious adverse event (SAE)
Approximately 3 days
Safety of multiple dose of BMS-986177 measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Approximately 16 days
Tolerability of single dose of BMS-986177 measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Approximately 3 days
Tolerability of multiple dose of BMS-986177 measured by number of subjects who experience SAE, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Approximately 16 days
Study Arms (2)
BMS-986177
EXPERIMENTALBMS-986177 specified dose on specified days
Placebo
OTHERPlacebo specified dose on specified days
Interventions
Eligibility Criteria
You may qualify if:
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations
- Body Mass Index (BMI) of 18 to 30 kg/m2 inclusive. BMI = weight (kg)/ \[height (m)\]2
- Females who are not of childbearing potential (i.e., who are post-menopausal or surgically sterile) and men ages 18 to 55, inclusive
You may not qualify if:
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
- Any condition that could affect drug absorption
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SGS Belgium NV
Antwerp, 2060, Belgium
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
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
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2015
First Posted
November 20, 2015
Study Start
December 31, 2015
Primary Completion
July 23, 2017
Study Completion
July 23, 2017
Last Updated
July 31, 2017
Record last verified: 2017-07