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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-21

Study Completion Date

2023-06-01

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BMS-986322 and Loestrin

Loestrin, then progress to combination

Group Type EXPERIMENTAL

BMS-986322

Intervention Type DRUG

Specified dose on specified days

Loestrin

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986322

Specified dose on specified days

Intervention Type DRUG

Loestrin

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes