Skip to main content
OpenTrials
Completed

NCT Number: NCT05891262

A Study to Evaluate the Drug-drug Interaction of BMS-986196 With Oral Contraceptives in Healthy Female Participants

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences

Cypress, California, 90630, United States

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

BMS-986196

Drug

Specified dose on specified days

Loestrin

Drug

Specified dose on specified days

Other names: Ethinyl estradiol (EE) and norethindrone (NET)

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: At Day 1 and Day 20

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

    Time frame: At Day 1 and Day 20

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

    Time frame: At Day 1 and Day 20

Secondary outcomes

  1. Time of maximum observed plasma concentration (Tmax)

    Time frame: At Day 1 and Day 20

  2. Terminal half-life (T-HALF)

    Time frame: At Day 1 and Day 20

  3. Apparent total body clearance (CLT/F)

    Time frame: At Day 1 and Day 20

  4. Number of participants with Adverse Events (AEs)

    Time frame: Up to Day 49

  5. Number of participants with Serious AEs (SAEs)

    Time frame: Up to Day 49

  6. Number of participants with clinical laboratory abnormalities

    Time frame: Up to Day 49

  7. Number of participants with vital sign abnormalities

    Time frame: Up to Day 49

  8. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to Day 49

  9. Number of participants with physical examination abnormalities

    Time frame: Up to Day 49

  10. Number of participants with any abnormal columbia-suicide severity rating scale (C-SSRS)

    Time frame: Up to Day 49

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 6, 2023
Registry last updated
Sep 25, 2023

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.

Published trials that share one or more normalized conditions with this study.