Healthy Volunteers Clinical Trial
Official title:
A Phase 1 Open-label Study to Assess the Effect of BMS-986419 on the Single Dose Pharmacokinetics of Probe Substrates (Caffeine, Bupropion, Flurbiprofen, Omeprazole, Midazolam, and Fexofenadine) in Healthy Participants
| Verified date | October 2023 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to assess the effect of BMS-986419 on the pharmacokinetics (PK) of single doses of caffeine (CYP1A2 substrate), bupropion (CYP2B6 substrate), midazolam (CYP3A4 substrate), flurbiprofen (CYP2C9 substrate), omeprazole (CYP2C19 substrate), and fexofenadine (P-gp substrate), in healthy participants.
| Status | Completed |
| Enrollment | 22 |
| Est. completion date | September 13, 2023 |
| Est. primary completion date | September 13, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility | Inclusion Criteria: - Healthy male and female participants without clinically significant deviation from normal in medical history, physical examination (PE), electrocardiogram (ECG), and clinical laboratory determinations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in (Day -1). - Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive, and total body weight = 50 kg. BMI may be rounded. Exclusion Criteria: - Any significant acute or chronic medical conditions or any significant acute or chronic medical illness as determined by the investigator - Any major surgery within 30 days of study intervention administration, such as gastrointestinal surgery that could impact the absorption of study intervention Other protocol-defined inclusion/exclusion criteria apply. |
| Country | Name | City | State |
|---|---|---|---|
| United States | ICON Lenexa | Lenexa | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum observed plasma concentration (Cmax) | Up to Day 25 | ||
| Primary | Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) | Up to Day 25 | ||
| Primary | Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Up to Day 25 | ||
| Secondary | Maximum observed plasma concentration (Cmax) | Up to Day 25 | ||
| Secondary | Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) | Up to Day 25 | ||
| Secondary | Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Up to Day 25 | ||
| Secondary | Number of participants with Adverse Events (AEs) | Up to 28 days after last dose | ||
| Secondary | Number of participants with Serious Adverse Events (SAEs) | Up to 28 days after last dose | ||
| Secondary | Number of participants with AEs leading to discontinuation | Up to 28 days after last dose | ||
| Secondary | Number of participants with vital sign abnormalities | Up to Day 25 | ||
| Secondary | Number of participants with 12-lead ECG assessment abnormalities | Up to Day 25 | ||
| Secondary | Number of participants with physical examination abnormalities | Up to Day 25 | ||
| Secondary | Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to Day 25 | ||
| Secondary | Number of participants with clinical laboratory abnormalities | Up to Day 25 |
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