A Study of Experimental Medication BMS-986036 Given to Healthy Participants
An Open-Label, Single-Dose, Fixed-Sequence Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986036 Administered to the Abdomen and Upper Arm in Healthy Participants
1 other identifier
interventional
30
1 country
1
Brief Summary
This is a study of experimental medication BMS-986036 given to healthy participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2018
Shorter than P25 for phase_1
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
February 14, 2018
CompletedFirst Submitted
Initial submission to the registry
February 20, 2018
CompletedFirst Posted
Study publicly available on registry
February 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2018
CompletedMarch 19, 2020
March 1, 2020
3 months
February 20, 2018
March 17, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
Maximum observed serum concentration (Cmax)
29 days
Time of maximum observed serum concentration (Tmax)
29 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-t)]
29 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(0-inf)]
29 days
Secondary Outcomes (6)
Number of injection site reactions
Up to 78 days
Number of adverse events (AE)
Up to 78 days
Number of serious adverse events (SAE)
Up to 78 days
Number of AEs leading to discontinuation
Up to 78 days
Number of deaths
Up to 78 days
- +1 more secondary outcomes
Study Arms (3)
Cohort 1
EXPERIMENTALBMI 18.0 to ≤ 25.0
Cohort 2
EXPERIMENTALBMI \>25.0 to ≤ 30.0
Cohort 3
EXPERIMENTALBMI \>30.0 ≤ 40.0
Interventions
Eligibility Criteria
You may qualify if:
- Healthy participant, as determined by no clinically significant deviations from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- BMI of 18 to ≤ 40 kg/m2
You may not qualify if:
- Presence of any factors that would predispose the participant to infection (eg, extensive periodontal disease that warrants surgical or medical treatment, unhealed open wounds)
- Any bone trauma (fracture) or bone surgery (i.e. hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration
- Known or suspected autoimmune disorder, excluding vitiligo
- Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
- Any significant acute or chronic medical illness
- Current or recent (within 3 months of study drug administration) gastrointestinal disease
- Any major surgery within 6 weeks of study drug administration
- History of diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PRA Health Sciences
Salt Lake City, Utah, 84107, United States
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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2018
First Posted
February 26, 2018
Study Start
February 14, 2018
Primary Completion
May 2, 2018
Study Completion
May 2, 2018
Last Updated
March 19, 2020
Record last verified: 2020-03