The Effect of BMS-986195 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients

• ClinicalTrials.gov Identifier: NCT03262740
• Recruitment Status: Completed
• First Posted: August 25, 2017
• Last Update Posted: February 28, 2018
• Sponsor: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

Study Description

Brief Summary:

The purpose of this study is to investigate the effect of BMS-986195 in combination with an oral contraceptive in healthy female patients.

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis	Drug: BMS-986195; Drug: Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol)	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 58 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of BMS-986195 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Subjects
• Actual Study Start Date: September 11, 2017
• Actual Primary Completion Date: December 19, 2017
• Actual Study Completion Date: January 30, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: BMS-986195 and Oral Contraceptive; Oral administration of contraceptive, then progress to combination	Drug: BMS-986195; 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 :

1. Maximum concentration (Cmax) derived from plasma concentration versus time [ Time Frame: Approximately 1 day ]
2. 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 Measures :

1. Adverse events measured by incidence [ Time Frame: Approximately 86 days ]
2. Serious adverse events measured by incidence [ Time Frame: Approximately 86 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Florida

Miami Research Associates

Miami, Florida, United States, 33173-5426

United States, Utah

PRA Health Sciences

Salt Lake City, Utah, United States, 84107

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trial Patient Recruiting  Investigator Inquiry Form 

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03262740 History of Changes
• Other Study ID Numbers: IM014-023
• First Posted: August 25, 2017
• Last Update Posted: February 28, 2018
• Last Verified: February 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Arthritis; Arthritis, Rheumatoid; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Estradiol 3-benzoate; Estradiol 17 beta-cypionate; Contraceptive Agents; Norethindrone; Norethindrone Acetate; Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination; Norinyl; Contraceptives, Oral; Estradiol; Polyestradiol phosphate; Ethinyl Estradiol; Estrogens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Combined; Contraceptives, Oral, Hormonal; Contraceptives, Oral, Sequential