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CompletedNCT03262727Updated Mar 19, 2020

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

A Phase 1 interventional study of BMS-986165 and Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol) in Systemic Lupus Erythematosus, Arthritic Psoriasis and Psoriasis, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-19.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
49
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

The purpose of this study is to investigate the effect of BMS-986165 in combination with an oral contraceptive in healthy female patients.

02

Conditions studied

  • Systemic Lupus Erythematosus
  • Arthritic Psoriasis
  • Psoriasis
  • Inflammatory Bowel Diseases
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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

04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    BMS-986165 and Oral Contraceptive

    Oral administration of contraceptive, then progress to combination

    Drug: BMS-986165 · Drug: Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol)

Interventions

  • DrugBMS-986165

    Oral administration of specified dose on specified days

  • DrugLoestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol)

    Oral Contraceptive

05

What researchers measure

Primary outcomes

  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 outcomes

  1. Adverse events measured by incidence

    Time frame: Approximately 86 days

  2. Serious adverse events measured by incidence

    Time frame: Approximately 86 days

06

Study locations

1 site
  • Miami Research Associates
    Miami, Florida 33173-5426, United States
07

References and documents

08

Registry details

Key details

Study ID
NCT03262727
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Aug 25, 2017
Start date
Sep 1, 2017
Primary completion
Nov 23, 2017
Completion
Dec 19, 2017
Last update
Mar 19, 2020

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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