Healthy Participants
Conditions
Keywords
BMS-986322, Loestrin, Combined oral hormonal contraceptive, Ethinyl Estradiol, Norethindrone, Drug-drug interaction
Brief summary
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.
Interventions
DRUGBMS-986322
Specified dose on specified days
DRUGLoestrin
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) for EE/NET | Up to 28 days |
| Cmax for EE/NET with BMS-986322 | Up to 28 days |
| Area under the concentration-time curve in 1 dosing interval (AUC[tau]) for EE/NET | Up to 28 days |
| AUC (tau) for EE/NET with BMS-986322 | Up to 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Time of maximum observed plasma concentration (Tmax) for EE/NET | Up to 28 days |
| Tmax for EE/NET with BMS-986322 | Up to 28 days |
| Tmax for BMS-986322 | Up to 31 days |
| Cmax for BMS-986322 | Up to 31 days |
| Cmax for BMS-986322 with EE/NET | Up to 31 days |
| Tmax for BMS-986322 with EE/NET | Up to 31 days |
| AUC (tau) for BMS-986322 with EE/NET | Up to 31 days |
| Number of participants with Adverse Events (AEs) | Up to 119 days |
| Number of participants with Serious AEs (SAEs) | Up to 119 days |
| Number of participants with physical examination abnormalities | Up to 119 days |
| AUC (tau) for BMS-986322 | Up to 31 days |
| Number of participants with vital sign abnormalities | Up to 119 days |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 119 days |
| Number of participants with clinical laboratory abnormalities | Up to 119 days |
Countries
United States
Outcome results
None listed