Skip to main content
OpenTrials
Completed

NCT Number: NCT04934696

A Study to Characterize the Drug Levels of an Oral Contraceptive With and Without BMS-986166 in Healthy Female Participants of Childbearing Potential

The purpose of this study is to investigate the potential for a drug-drug interaction (DDI) when BMS-986166 and hormonal oral contraceptives are co-administered.

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

West Coast Clinical Trials Global

Cypress, California, 90630, United States

Who can participate

Healthy volunteers accepted: Yes

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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com

Inclusion criteria

  • Nonpregnant, nonlactating Women of Childbearing Potential (WOCBP) who are healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations will be eligible to participate in the study.
  • Body mass index (BMI) of 18.0 to 32.0 kg/m². BMI = weight (kg)/(height[m])² for participants.
  • Participant must be 18 to 45 years of age, inclusive, at the time of signing the informed consent.

Exclusion criteria

  • Any significant acute or chronic medical illness judged to be clinically significant by the investigator and/or Sponsor Medical Monitor.
  • History of any type of heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, symptomatic orthostatic hypotension, atrioventricular block of any degree, bradycardia, syncope, clinically significant ECG abnormalities, or any congenital heart disease.
  • Any acute or chronic bacterial, fungal (except history of tinea pedis or ongoing onychomycosis will not be exclusionary) or viral infection within the last 3 months prior to screening, as well as any febrile illness or viral infection within the last 3 months prior to screening, as well as any febrile illness of unknown origin within 14 days of screening.

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

BMS-986166

Drug

Specified dose on specified days

Oral contraceptive

Drug

Specified dose on specified days

Primary outcomes

  1. Geometric means ratio of Cmax of NET

    Time frame: Up to Day 26

    Geometric means ratio of maximum observed plasma concentration (Cmax) of norethindrone (NET) when administered with versus without BMS-986166

  2. Geometric means ratio of Cmax of EE

    Time frame: Up to Day 26

    Geometric means ratio of maximum observed plasma concentration (Cmax) of ethinyl estradiol (EE) when administered with versus without BMS-986166

  3. Geometric means ratio of AUC(0-T) of NET

    Time frame: Up to Day 26

    Geometric means ratio of area under the plasma concentration-time curve from time zero to time of last quantifiable concentration for NET when administered with versus without BMS-986166

  4. Geometric means ratio of AUC(0-T) of EE

    Time frame: Up to Day 26

    Geometric means ratio of area under the plasma concentration-time curve from time zero to time of last quantifiable concentration for EE when administered with versus without BMS-986166

  5. Geometric means ratio of AUC(INF) of NET

    Time frame: Up to Day 26

    Geometric means ratio of area under the plasma concentration-time curve from time zero extrapolated to infinite time for NET administered with versus without BMS-986166

  6. Geometric means ratio of AUC(INF) of EE

    Time frame: Up to Day 26

    Geometric means ratio of area under the plasma concentration-time curve from time zero extrapolated to infinite time for EE when administered with versus without BMS-986166

Secondary outcomes

  1. Cmax of BMS-986166

    Time frame: Up to Day 26

  2. Cmax of BMT-121795

    Time frame: Up to Day 26

  3. Time of maximum observed plasma concentration (Tmax) of BMS-986166

    Time frame: Up to Day 26

  4. Tmax of BMT-121795

    Time frame: Up to Day 26

  5. Area under the plasma concentration-time curve in one dosing interval (AUC(TAU)) of BMS-986166

    Time frame: Up to Day 26

  6. AUC(TAU) of BMT-121795

    Time frame: Up to Day 26

  7. Tmax of EE

    Time frame: Up to Day 26

  8. Tmax of NET

    Time frame: Up to Day 26

  9. Terminal plasma elimination phase half-life (T-HALF) of EE

    Time frame: Up to Day 26

  10. T-HALF of NET

    Time frame: Up to Day 26

  11. Apparent total clearance of drug from plasma after oral administration (CLT/F) of EE

    Time frame: Up to Day 26

  12. CLT/F of NET

    Time frame: Up to Day 26

  13. Apparent volume of distribution at terminal phase (Vz/F) of EE

    Time frame: Up to Day 26

  14. Vz/F of NET

    Time frame: Up to Day 26

  15. Number of participants with Adverse Events (AEs)

    Time frame: Up to Day 37

  16. Number of participants with Serious Adverse Events (SAEs)

    Time frame: Up to Day 37

  17. Number of participants with clinically significant changes in laboratory values: Hematology tests

    Time frame: Up to Day 30

  18. Number of participants with clinically significant changes in laboratory values: Chemistry tests

    Time frame: Up to Day 30

  19. Number of participants with clinically significant changes in laboratory values: Urinalysis

    Time frame: Up to Day 30

  20. Number of participants with clinically significant changes in vital signs: Body temperature

    Time frame: Up to Day 27

  21. Number of participants with clinically significant changes in vital signs: Respiratory rate

    Time frame: Up to Day 27

  22. Number of participants with clinically significant changes in vital signs: Blood pressure

    Time frame: Up to Day 27

  23. Number of participants with clinically significant changes in vital signs: Heart rate

    Time frame: Up to Day 27

  24. Number of participants with clinically significant changes in ECG parameters: PR interval

    Time frame: Up to Day 27

    PR interval is the time from the onset of the P wave to the start of the QRS complex

  25. Number of participants with clinically significant changes in ECG parameters: QRS

    Time frame: Up to Day 27

    QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization

  26. Number of participants with clinically significant changes in ECG parameters: QT interval

    Time frame: Up to Day 27

    The QT interval is the time from the start of the Q wave to the end of the T wave

  27. Number of participants with clinically significant changes in ECG parameters: QTcF

    Time frame: Up to Day 27

    QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave

  28. Number of participants with physical examination abnormalities

    Time frame: Up to Day 27

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1 Study to Characterize the Effects of BMS-986166 on the Pharmacokinetics of an Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone in Healthy Female Participants

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 22, 2021
Registry last updated
Mar 18, 2022

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.