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Completed

NCT Number: NCT05985590

A Study to Investigate the Effects of BMS-986278 on Drospirenone and Ethinyl Estradiol Drug Levels in Healthy Female Participants

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0002

Québec, Quebec, G1P 0A2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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/exclusion criteria apply.

Treatment and study plan

BMS-986278

Drug

Specified dose on specified days

Drospirenone/Ethinyl Estradiol

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Predose and post-dose up to Day 28

  2. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])

    Time frame: Predose and post-dose up to Day 28

  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF])

    Time frame: Predose and post-dose up to Day 28

Secondary outcomes

  1. Time of maximum observed concentration (Tmax)

    Time frame: Predose and post-dose up to Day 28

  2. Terminal half-life (T-Half)

    Time frame: Predose and post-dose up to Day 28

  3. Apparent total body clearance after extravascular administration (CL/F)

    Time frame: Predose and post-dose up to Day 28

  4. Number of Participants with Adverse Events (AEs)

    Time frame: Up to Day 53

  5. Number of Participants with Serious AEs (SAEs)

    Time frame: Up to Day 53

  6. Number of Participants with AEs leading to discontinuation

    Time frame: Up to Day 53

  7. Number of Participants with Physical Examination Abnormalities

    Time frame: Up to Day 28

  8. Number of Participants with Vital Sign Abnormalities

    Time frame: Up to Day 28

  9. Number of Participants with Electrocardiogram (ECG) Abnormalities

    Time frame: Up to Day 28

  10. Number of Participants with Clinical Laboratory Abnormalities

    Time frame: Up to Day 27

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effects of Multiple Doses of BMS-986278 on the Pharmacokinetics of Combined Oral Contraceptives (Drospirenone/Ethinyl Estradiol) in Healthy Female Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 14, 2023
Registry last updated
Jan 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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