Healthy Volunteers
Conditions
Keywords
Pharmacokinetics, BMS-986278, Hormonal contraceptives, Ethinyl estradiol, Drospirenone, Pulmonary fibrosis
Brief summary
The purpose of the study is to assess the effects of BMS-986278 on Drospirenone (DRSP) and Ethinyl Estradiol (EE) when administered as a combined oral contraceptive in healthy female participants.
Interventions
DRUGBMS-986278
Specified dose on specified days
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index between 18.0 and 32.0 kilograms/meter square (kg/m\^2), inclusive. * Body weight ≥ 45 kg. * Healthy females, as determined by physical examination and clinical laboratory assessments (including chemistry, hematology, coagulation, and urinalysis) within the normal range at the screening visit and on Day -1, as applicable.
Exclusion criteria
* Any significant acute or chronic medical illness. * Any gastrointestinal (GI) disease or surgery (including cholecystectomy) or other procedures (eg, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion. Note: Appendectomy is allowed (12 months prior to screening). * Any other clinically significant medical, psychiatric, and/or social reason, or other active issues, especially eye issues, as determined by the investigator. Note: Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) | Predose and post-dose up to Day 28 |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]) | Predose and post-dose up to Day 28 |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF]) | Predose and post-dose up to Day 28 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events (AEs) | Up to Day 53 |
| Number of Participants with Serious AEs (SAEs) | Up to Day 53 |
| Number of Participants with AEs leading to discontinuation | Up to Day 53 |
| Time of maximum observed concentration (Tmax) | Predose and post-dose up to Day 28 |
| Number of Participants with Vital Sign Abnormalities | Up to Day 28 |
| Number of Participants with Electrocardiogram (ECG) Abnormalities | Up to Day 28 |
| Number of Participants with Clinical Laboratory Abnormalities | Up to Day 27 |
| Number of Participants with Physical Examination Abnormalities | Up to Day 28 |
| Terminal half-life (T-Half) | Predose and post-dose up to Day 28 |
| Apparent total body clearance after extravascular administration (CL/F) | Predose and post-dose up to Day 28 |
Countries
Canada
Outcome results
None listed