NCT05852769CompletedPhase 1
A Phase 1, Single-center, Open-label, Sequential Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants
Bristol-Myers Squibb1 site in 1 country18 target enrollmentStarted: May 31, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Study Overview
Brief Summary
This study is designed to assess the effect of BMS-986196 on the drug levels of caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin in healthy participants.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
- •Body mass index of 18.0 to 33.0 kilogram per meter squared (kg/m^2), inclusive, and body weight ≥50.0 kg.
Exclusion Criteria
- •History of rhabdomyolysis.
- •History of peptic ulcer disease or significant GI bleeding.
- •History of malignancy in the 5 years prior to screening (except fully excised basal cell carcinoma).
Arms & Interventions
BMS-986196 and/or Cocktail Probe Substrate Drugs
Experimental
Intervention: Pravastatin (Drug)
BMS-986196 and/or Cocktail Probe Substrate Drugs
Experimental
Intervention: BMS-986196 (Drug)
BMS-986196 and/or Cocktail Probe Substrate Drugs
Experimental
Intervention: Caffeine (Drug)
BMS-986196 and/or Cocktail Probe Substrate Drugs
Experimental
Intervention: Montelukast (Drug)
BMS-986196 and/or Cocktail Probe Substrate Drugs
Experimental
Intervention: Flurbiprofen (Drug)
BMS-986196 and/or Cocktail Probe Substrate Drugs
Experimental
Intervention: Omeprazole (Drug)
BMS-986196 and/or Cocktail Probe Substrate Drugs
Experimental
Intervention: Midazolam (Drug)
BMS-986196 and/or Cocktail Probe Substrate Drugs
Experimental
Intervention: Digoxin (Drug)
Outcomes
Primary Outcomes
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Time Frame: Up to 26 days
Maximum observed plasma concentration (Cmax)
Time Frame: Up to 26 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])
Time Frame: Up to 26 days
Secondary Outcomes
- Number of participants with adverse events (AEs)(Up to 52 days)
- Number of participants with vital sign abnormalities(Up to 28 days)
- Number of participants with physical examination abnormalities(Up to 28 days)
- Number of participants with clinical laboratory abnormalities(Up to 28 days)
- Intensity of Suicidal Ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Score(Up to 28 days)
- Time of maximum observed serum concentration (Tmax)(Up to 26 days)
- Apparent terminal phase half-life (T-Half)(Up to 26 days)
- Apparent total body clearance (CLT/F)(Up to 26 days)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to 21 days)
Investigators
Study Sites (1)
Loading locations...
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