NCT03445208CompletedPhase 1
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
Bristol-Myers Squibb1 site in 1 country30 target enrollmentStarted: February 14, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Maximum observed serum concentration (Cmax)
Study Overview
Brief Summary
This is a study of experimental medication BMS-986036 given to healthy participants.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •Other protocol defined inclusion/exclusion criteria could apply
Arms & Interventions
Cohort 1
Experimental
BMI 18.0 to ≤ 25.0
Intervention: BMS-986036 (Drug)
Cohort 2
Experimental
BMI >25.0 to ≤ 30.0
Intervention: BMS-986036 (Drug)
Cohort 3
Experimental
BMI >30.0 ≤ 40.0
Intervention: BMS-986036 (Drug)
Outcomes
Primary Outcomes
Maximum observed serum concentration (Cmax)
Time Frame: 29 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-t)]
Time Frame: 29 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(0-inf)]
Time Frame: 29 days
Time of maximum observed serum concentration (Tmax)
Time Frame: 29 days
Secondary Outcomes
- Number of adverse events (AE)(Up to 78 days)
- Serum biomarker antibody concentration(Up to 78 days)
- Number of injection site reactions(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)
Investigators
Study Sites (1)
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