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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03262740
Other study ID # IM014-023
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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