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Completed

NCT Number: NCT05579574

A Study to Investigate the Interaction of BMS-986322 and a Combined Oral Hormonal Contraceptive (Ethinyl Estradiol [EE]/Norethindrone [NET]) in Healthy Female Participants

The purpose of this study is to evaluate the effect of multiple doses of BMS-986322 on the pharmacokinetics (PK) of Loestrin components in healthy female participants.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy participants, defined as having no clinically significant active or ongoing medical condition, physical examination abnormality, abnormal ECG finding, and abnormal clinical laboratory determinations that in the opinion of the investigator would compromise the conduct, results, or interpretation of the study findings.
  • Have a negative QuantiFERON®-TB Gold test result at screening or documentation of a negative result within 4 weeks prior to the start of study intervention.
  • Have a normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) ≥ 80 milliliter (mL)/minute (min)/1.732m^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.

Exclusion criteria

  • Any significant acute or chronic medical illness.
  • Any acute infection or febrile illness within 7 days before Day 1 of Cycle 2.
  • Any history or risk for tuberculosis (TB), specifically participants with 1) current clinical, radiographic or laboratory evidence of active TB; 2) history of active TB unless there is documentation that the prior anti-TB treatment was appropriate in duration and type; latent TB that has not been successfully treated.

Other protocol-defined inclusion/exclusion criteria apply.

Treatment and study plan

BMS-986322

Drug

Specified dose on specified days

Loestrin

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) for EE/NET

    Time frame: Up to 28 days

  2. Cmax for EE/NET with BMS-986322

    Time frame: Up to 28 days

  3. Area under the concentration-time curve in 1 dosing interval (AUC[tau]) for EE/NET

    Time frame: Up to 28 days

  4. AUC (tau) for EE/NET with BMS-986322

    Time frame: Up to 28 days

Secondary outcomes

  1. Cmax for BMS-986322

    Time frame: Up to 31 days

  2. Cmax for BMS-986322 with EE/NET

    Time frame: Up to 31 days

  3. AUC (tau) for BMS-986322

    Time frame: Up to 31 days

  4. AUC (tau) for BMS-986322 with EE/NET

    Time frame: Up to 31 days

  5. Number of participants with Adverse Events (AEs)

    Time frame: Up to 119 days

  6. Number of participants with Serious AEs (SAEs)

    Time frame: Up to 119 days

  7. Number of participants with physical examination abnormalities

    Time frame: Up to 119 days

  8. Number of participants with vital sign abnormalities

    Time frame: Up to 119 days

  9. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to 119 days

  10. Number of participants with clinical laboratory abnormalities

    Time frame: Up to 119 days

  11. Time of maximum observed plasma concentration (Tmax) for EE/NET

    Time frame: Up to 28 days

  12. Tmax for EE/NET with BMS-986322

    Time frame: Up to 28 days

  13. Tmax for BMS-986322

    Time frame: Up to 31 days

  14. Tmax for BMS-986322 with EE/NET

    Time frame: Up to 31 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

An Open-Label, Single-Sequence, Crossover Study to Investigate the Interaction of Multiple Doses of BMS-986322 at Steady State and Multiple Doses of a Combined Oral Hormonal Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Participants

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2022
Registry last updated
Aug 18, 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.

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