Healthy Volunteers Clinical Trial
Official title:
A Phase 1, Single-center, Open-label, Sequential Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants
| Verified date | September 2023 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 18 |
| Est. completion date | August 24, 2023 |
| Est. primary completion date | August 24, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility | 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). |
| Country | Name | City | State |
|---|---|---|---|
| United States | ICON plc | Millcreek | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum observed plasma concentration (Cmax) | Up to 26 days | ||
| Primary | Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) | Up to 26 days | ||
| Primary | Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T]) | Up to 26 days | ||
| Secondary | Time of maximum observed serum concentration (Tmax) | Up to 26 days | ||
| Secondary | Apparent terminal phase half-life (T-Half) | Up to 26 days | ||
| Secondary | Apparent total body clearance (CLT/F) | Up to 26 days | ||
| Secondary | Number of participants with adverse events (AEs) | Up to 52 days | ||
| Secondary | Number of participants with vital sign abnormalities | Up to 28 days | ||
| Secondary | Number of participants with electrocardiogram (ECG) abnormalities | Up to 21 days | ||
| Secondary | Number of participants with physical examination abnormalities | Up to 28 days | ||
| Secondary | Number of participants with clinical laboratory abnormalities | Up to 28 days | ||
| Secondary | Intensity of Suicidal Ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Up to 28 days |
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