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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT03262727

Collaborator

(none)

Enrollment

Location

Arm

3.6

Actual Duration (Months)

13.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus Arthritic Psoriasis Psoriasis Inflammatory Bowel Diseases	Drug: BMS-986165 Drug: Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2017

Actual Primary Completion Date :

Nov 23, 2017

Actual Study Completion Date :

Dec 19, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMS-986165 and Oral Contraceptive Oral administration of contraceptive, then progress to combination	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

Arm

Intervention/Treatment

Experimental: BMS-986165 and Oral Contraceptive

Oral administration of contraceptive, then progress to combination

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

Outcome Measures

Primary Outcome Measures

Maximum concentration (Cmax) derived from plasma concentration versus time [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 [Approximately 1 day]

Secondary Outcome Measures

Adverse events measured by incidence [Approximately 86 days]
Serious adverse events measured by incidence [Approximately 86 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive,
Weight ≥ 50 kg
Negative result for tuberculosis (TB) as evidenced by a QuantiFERON-TB Gold Plus test at screening, or documentation of a negative result within 4 weeks before Cycle 1, Day 1
Women of childbearing potential with intact ovarian function, on a stable regimen of combination birth control containing EE without evidence of clinically significant breakthrough bleeding or spotting for at least 2 consecutive months prior to Cycle 1 Day -1
Subjects aged 21 years or older must have a normal Pap smear result within 3 years before Cycle 1 Day 1 (a Pap smear may be performed at screening if no result is available); a finding of abnormal squamous cells of unknown significance (ASCUS) is allowed provided it is an initial finding and not a follow up from an initial finding of ASCUS

Exclusion Criteria:

Exposure to an investigational agent within 12 weeks before Cycle 1 Day 1
Subjects who are pregnant or breastfeeding
Any significant acute or chronic medical illness including infection, any active infection, febrile illness within 7 days before Cycle 1, Day 1, or any condition that could predispose the subject to infection
History of recurrent or chronic sinusitis, bronchitis, pneumonia, urinary tract infection (recurrent or chronic urinary tract infection is 2 episodes within 6 months)
Any serious acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening
Known or suspected autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the subject's immune status (eg, history of splenectomy, primary immunodeficiency, etc)