Healthy Female Volunteers Clinical Trial
Official title:
A Phase 1, Single-center, Open-label, Single-sequence Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 With Oral Contraceptives in Healthy Female Participants
| Verified date | September 2023 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the effect of BMS-986196 when coadministered with combined hormonal oral contraceptives (ethinyl estradiol [EE] and norethindrone [NET]) in healthy female participants.
| Status | Completed |
| Enrollment | 15 |
| Est. completion date | August 25, 2023 |
| Est. primary completion date | August 25, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility | Inclusion Criteria: - Participants must be genetically and hormonally female with intact ovarian function by medical history/menstrual cycles. - Body mass index between 18.0 and 35.0 kilograms/meter square (kg/m^2), inclusive, at screening. - Healthy female participants as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations. Exclusion Criteria: - Any significant acute or chronic medical illness judged to be clinically significant by the investigator and/or Sponsor Medical Monitor. - History of clinically significant heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, clinically significant ECG abnormalities, venous thromboembolism, or any congenital heart disease (as assessed by the investigator). - Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could possibly affect drug absorption, distribution, metabolism and excretion (for example, bariatric procedure). - Any major surgery within 4 weeks of study intervention administration, including gastrointestinal surgery that could affect the absorption of study intervention. Note: Other protocol-defined inclusion/exclusion criteria apply. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Altasciences | Cypress | California |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum observed plasma concentration (Cmax) | At Day 1 and Day 20 | ||
| Primary | Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]) | At Day 1 and Day 20 | ||
| Primary | Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF]) | At Day 1 and Day 20 | ||
| Secondary | Time of maximum observed plasma concentration (Tmax) | At Day 1 and Day 20 | ||
| Secondary | Terminal half-life (T-HALF) | At Day 1 and Day 20 | ||
| Secondary | Apparent total body clearance (CLT/F) | At Day 1 and Day 20 | ||
| Secondary | Number of participants with Adverse Events (AEs) | Up to Day 49 | ||
| Secondary | Number of participants with Serious AEs (SAEs) | Up to Day 49 | ||
| Secondary | Number of participants with clinical laboratory abnormalities | Up to Day 49 | ||
| Secondary | Number of participants with vital sign abnormalities | Up to Day 49 | ||
| Secondary | Number of participants with electrocardiogram (ECG) abnormalities | Up to Day 49 | ||
| Secondary | Number of participants with physical examination abnormalities | Up to Day 49 | ||
| Secondary | Number of participants with any abnormal columbia-suicide severity rating scale (C-SSRS) | Up to Day 49 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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