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

Phase 1

Completed

• Conditions: Systemic Lupus Erythematosus; Psoriasis; Inflammatory Bowel Diseases; Arthritic Psoriasis
• Interventions: Drug: BMS-986165; Drug: Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol)

• Registration Number: NCT03262727
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-24
• Study First Submitted QC: 2017-08-24
• Study First Posted: 2017-08-25
• Study Start: 2017-09-01
• Primary Completion: 2017-11-23
• Study Completion: 2017-12-19
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 49

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

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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)

Other protocol defined inclusion/exclusion criteria could apply

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMS-986165 and Oral Contraceptive	BMS-986165	Oral administration of contraceptive, then progress to combination
BMS-986165 and Oral Contraceptive	Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol)	Oral administration of contraceptive, then progress to combination

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Adverse events measured by incidence	Approximately 86 days
Serious adverse events measured by incidence	Approximately 86 days

Trial Locations

Locations (1)

Miami Research Associates; 🇺🇸 Miami, Florida, United States