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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03262727
• Date of registration: 24/08/2017
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: The Effect of BMS-986165 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients
• Scientific title: The Effect of BMS-986165 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Subjects
• Date of first enrolment: September 1, 2017
• Target sample size: 49
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03262727
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

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)

Other protocol defined inclusion/exclusion criteria could apply



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Inflammatory Bowel Diseases

Psoriasis

Arthritic Psoriasis

Systemic Lupus Erythematosus

Intervention(s)

Drug: BMS-986165

Drug: Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 µg ethinyl estradiol)

Primary Outcome(s)

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]

Secondary Outcome(s)

Adverse events measured by incidence [Time Frame: Approximately 86 days]

Serious adverse events measured by incidence [Time Frame: Approximately 86 days]

Secondary ID(s)

IM011-039

Source(s) of Monetary Support

Please refer to primary and secondary sponsors