NCT03262727

The Effect of BMS-986165 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients

The Effect of BMS-986165 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the effect of BMS-986165 in combination with an oral contraceptive in healthy female patients.

Conditions

• Systemic Lupus Erythematosus
• Arthritic Psoriasis
• Psoriasis
• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
DRUG	BMS-986165	Oral administration of specified dose on specified days
DRUG	Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol)	Oral Contraceptive

Timeline

• Start date: 2017-09-01
• Primary completion: 2017-11-23
• Completion: 2017-12-19
• First posted: 2017-08-25
• Last updated: 2020-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study