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

Rheumatoid Arthritis Clinical Trial

Official title:

The Effect of BMS-986195 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03262740
• Other study ID #: IM014-023
• Status: Completed
• Phase: Phase 1
• Start date: September 11, 2017
• Est. completion date: January 30, 2018

Study information

• Verified date: March 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 30, 2018
• Est. primary completion date: December 19, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• BMS-986195
Oral administration of specified dose on specified days
• Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 µg ethinyl estradiol)
Oral Contraceptive

Locations

Country	Name	City	State
United States	PRA Health Sciences	Salt Lake City	Utah
United States	Miami Research Associates	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum concentration (Cmax) derived from plasma concentration versus time		Approximately 1 day
Primary	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	Adverse events measured by incidence		Approximately 86 days
Secondary	Serious adverse events measured by incidence		Approximately 86 days

External Links

•   BMS Clinical Trial Patient Recruiting
•   Investigator Inquiry Form