NCT02832180

Brief Summary

This is an open-label, 2-cycle, multiple-dose, single-sequence study in women of child-bearing potential. The primary objective is to assess the effect of BMS-986142 on the pharmacokinetics (PK) of Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

December 26, 2016

Status Verified

December 1, 2016

Enrollment Period

5 months

First QC Date

May 16, 2016

Last Update Submit

December 23, 2016

Conditions

Arthritis

Keywords

Rheumatoid

Outcome Measures

Primary Outcomes (3)

  • Maximum observed plasma concentration (Cmax) of EE and NET

    Cycle 1 Day 21 to Cycle 2 Day 22 (30 days)

  • Area under the concentration-time curve (AUC) of EE and NET

    Cycle 1 Day 21 to Cycle 2 Day 22 (30 days)

  • Area under the concentration-time curve over the dosing interval [AUC (TAU)] of EE and NET

    Cycle 1 Day 21 to Cycle 2 Day 22 (30 days)

Secondary Outcomes (1)

  • Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death.

    Cycle 1 Day 1 to Cycle 2 Day 25; For SAEs up to 30 days post discontinuation of dosing or participation.

Study Arms (2)

Daily single dose of OC containing EE and NET

EXPERIMENTAL

Daily single dose of OC Containing EE and NET alone.

Drug: OC containing EE and NET

Daily single dose of OC in combination with BMS-986142

EXPERIMENTAL

Daily single dose of OC containing EE and NET in combination with BMS-986142.

Drug: OC containing EE and NETDrug: BMS-986142

Interventions

OC containing EE and NETDRUG
Daily single dose of OC containing EE and NETDaily single dose of OC in combination with BMS-986142
BMS-986142DRUG
Daily single dose of OC in combination with BMS-986142

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Signed Informed Consent
  • Target population: Healthy females with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests that are willing to switch to Loestrin during the study.
  • Body Mass Index (BMI) between 18 to 32 kg/m2.
  • Women of childbearing potential with intact ovarian function and history of regular menstrual cycles must have been on a stable regimen of combination of birth control containing ethinyl estradiol without evidence of clinically significant breakthrough bleeding or spotting for at least 2 consecutive months prior to Day -1.
  • Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drugs (53 days) plus 5 half-lives of BMS-986142 (3 days) plus 30 days (duration of ovulatory cycle) for a total of 86 days.

You may not qualify if:

  • History of any chronic or acute illness including active TB in the last 3 years, recent infection, gastrointestinal disease, smoking within less than 6 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured.
  • History of jaundice or irregular bleeding associated with taking oral contraceptives, frequent headaches, cerebrovascular or coronary-artery disease, retinal vascular lesions, cancer of the breast or endometrium, deep venous thrombosis, pulmonary embolism, stroke, transient ischemic attack, or phlebitis.
  • Vaccination or plans for vaccination with any live vaccine 12 weeks prior to first dose of study drug, during the course of the study, or 30 days after the last dose of study drug.
  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiograms, or clinical laboratory determinations beyond what is consistent with the target population.
  • History of allergies and adverse drug reaction to any oral contraceptive compounds or Bruton tyrosine kinase (BTK) inhibitors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Miami Research Associates

Miami, Florida, 33143, United States

Location

Covance Evansville Clinical Research Unit

Evansville, Indiana, 47710, United States

Location

Related Links

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2016

First Posted

July 14, 2016

Study Start

May 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

December 26, 2016

Record last verified: 2016-12

Locations

US(2)