NCT03262740

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P50-P75 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Sep 2017

Shorter than P25 for phase_1 rheumatoid-arthritis

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

First Submitted

Initial submission to the registry

August 24, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

September 11, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2018

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

August 24, 2017

Last Update Submit

March 19, 2020

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

  • Maximum concentration (Cmax) derived from plasma concentration versus time

    Approximately 1 day

  • 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 Outcomes (2)

  • Adverse events measured by incidence

    Approximately 86 days

  • Serious adverse events measured by incidence

    Approximately 86 days

Study Arms (1)

BMS-986195 and Oral Contraceptive

EXPERIMENTAL

Oral administration of contraceptive, then progress to combination

Drug: BMS-986195Drug: Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol)

Interventions

BMS-986195DRUG

Oral administration of specified dose on specified days

BMS-986195 and Oral Contraceptive
Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol)DRUG

Oral Contraceptive

BMS-986195 and Oral Contraceptive

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Miami Research Associates

South Miami, Florida, 33143, United States

Location

PRA Health Sciences

Salt Lake City, Utah, 84124, United States

Location

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

branebrutinib

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2017

First Posted

August 25, 2017

Study Start

September 11, 2017

Primary Completion

December 19, 2017

Study Completion

January 30, 2018

Last Updated

March 20, 2020

Record last verified: 2020-03

Locations

US(2)