A Phase 1 interventional study of BMS-986165 and Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol) in Systemic Lupus Erythematosus, Arthritic Psoriasis and Psoriasis, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-19.
Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment
The purpose of this study is to investigate the effect of BMS-986165 in combination with an oral contraceptive in healthy female patients.
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
Oral administration of contraceptive, then progress to combination
Drug: BMS-986165 · Drug: Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol)
Oral administration of specified dose on specified days
Oral Contraceptive
Maximum concentration (Cmax) derived from plasma concentration versus time
Time frame: Approximately 1 day
Area under the plasma concentration-time curve to the end of the dosing period [AUC(tau)] derived from plasma concentration versus time
Time frame: Approximately 1 day
Adverse events measured by incidence
Time frame: Approximately 86 days
Serious adverse events measured by incidence
Time frame: Approximately 86 days
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Bristol-Myers Squibb