NCT04934696

Brief Summary

The purpose of this study is to investigate the potential for a drug-drug interaction (DDI) when BMS-986166 and hormonal oral contraceptives are co-administered.

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 Aug 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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

June 17, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 22, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

August 3, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2022

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

June 17, 2021

Last Update Submit

March 7, 2022

Conditions

Healthy Participants

Keywords

Healthy ParticipantsBMS-986166

Outcome Measures

Primary Outcomes (6)

  • Geometric means ratio of Cmax of NET

    Geometric means ratio of maximum observed plasma concentration (Cmax) of norethindrone (NET) when administered with versus without BMS-986166

    Up to Day 26

  • Geometric means ratio of Cmax of EE

    Geometric means ratio of maximum observed plasma concentration (Cmax) of ethinyl estradiol (EE) when administered with versus without BMS-986166

    Up to Day 26

  • Geometric means ratio of AUC(0-T) of NET

    Geometric means ratio of area under the plasma concentration-time curve from time zero to time of last quantifiable concentration for NET when administered with versus without BMS-986166

    Up to Day 26

  • Geometric means ratio of AUC(0-T) of EE

    Geometric means ratio of area under the plasma concentration-time curve from time zero to time of last quantifiable concentration for EE when administered with versus without BMS-986166

    Up to Day 26

  • Geometric means ratio of AUC(INF) of NET

    Geometric means ratio of area under the plasma concentration-time curve from time zero extrapolated to infinite time for NET administered with versus without BMS-986166

    Up to Day 26

  • Geometric means ratio of AUC(INF) of EE

    Geometric means ratio of area under the plasma concentration-time curve from time zero extrapolated to infinite time for EE when administered with versus without BMS-986166

    Up to Day 26

Secondary Outcomes (28)

  • Cmax of BMS-986166

    Up to Day 26

  • Cmax of BMT-121795

    Up to Day 26

  • Time of maximum observed plasma concentration (Tmax) of BMS-986166

    Up to Day 26

  • Tmax of BMT-121795

    Up to Day 26

  • Area under the plasma concentration-time curve in one dosing interval (AUC(TAU)) of BMS-986166

    Up to Day 26

  • +23 more secondary outcomes

Study Arms (1)

BMS-986166 + Oral contraceptive

EXPERIMENTAL
Drug: BMS-986166Drug: Oral contraceptive

Interventions

BMS-986166DRUG

Specified dose on specified days

BMS-986166 + Oral contraceptive
Oral contraceptiveDRUG

Specified dose on specified days

BMS-986166 + Oral contraceptive

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Nonpregnant, nonlactating Women of Childbearing Potential (WOCBP) who are healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations will be eligible to participate in the study.
  • Body mass index (BMI) of 18.0 to 32.0 kg/m². BMI = weight (kg)/(height\[m\])² for participants.
  • Participant must be 18 to 45 years of age, inclusive, at the time of signing the informed consent.

You may not qualify if:

  • Any significant acute or chronic medical illness judged to be clinically significant by the investigator and/or Sponsor Medical Monitor.
  • History of any type of heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, symptomatic orthostatic hypotension, atrioventricular block of any degree, bradycardia, syncope, clinically significant ECG abnormalities, or any congenital heart disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Coast Clinical Trials Global

Cypress, California, 90630, United States

Location

Related Links

MeSH Terms

Interventions

BMS-986166Contraceptives, Oral

Intervention Hierarchy (Ancestors)

Contraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic Uses

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2021

First Posted

June 22, 2021

Study Start

August 3, 2021

Primary Completion

January 25, 2022

Study Completion

January 25, 2022

Last Updated

March 18, 2022

Record last verified: 2022-03

Locations

US(1)