A Study Measuring the Effectiveness of BMS-986256 Combine... | NCT04016753

Studies
A Study Measuring the Effectiveness of BMS-986256 Combined With Oral Contraceptive in Healthy Female Participants

NCT04016753

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

May 31, 2022Actual

Enrollment

32Actual

Phase

Phase 1

Conditions

Healthy Participants

Interventions

BMS-986256
Loestrin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 5, 2019Actual

Primary Completion Date

Feb 21, 2020Actual

Completion Date

Feb 21, 2020Actual

First Submitted Date

Jun 26, 2019

First Submission Date that Met QC Criteria

Jul 10, 2019

First Posted Date

Jul 11, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2022

Last Update Posted Date

May 31, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A comparative study of BMS-986256 with a combined oral contraceptive in healthy female participants to determine the effectiveness when taken together

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Label	Type	Description	Intervention Names
Monotherapy	Experimental		Drug: BMS-986256 Drug: Loestrin

Name	Type	Description	Arm Group Labels	Other Names
BMS-986256	Drug	30 mg(6ml)	Monotherapy
Loestrin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum observed plasma Concentration (Cmax) of Norethindrone (NET)		Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
Area under the plasma concentration-time curve over the dosing interval AUC(TAU) of NET		Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
Maximum observed plasma Concentration (Cmax) of Ethinyl Estradiol (EE)		Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
Area under the plasma concentration-time curve over the dosing interval AUC(TAU)of (EE)		Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)

Secondary Outcomes

Measure	Description	Time Frame
Incidence of Adverse Events (AEs)		Up to 28 weeks
Incidence of Serious Adverse Events (SAEs)		Up to 28 weeks
Serology clinical lab assessment of blood

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants must be a non- smoking genetically female, who has normal renal function, willing to use Loestrin, and of childbearing Potential with intact ovarian function.
Participants must be healthy, defined as having no clinically significant active or ongoing medical condition Weighing less than or equal to 50 kg and a body mass index between 18.0 and 32.0kg inclusive at screening.
Participant must have a negative QuantiFeron- TB Gold test at screening and have a normal pap smear result within 3 years.

Exclusion Criteria:

Participants who are involuntarily incarcerated, have a significant Chronic medical illness or a history of relevant drug allergy to immunologic or related compounds.
Any serious bacterial, fungal, or viral infection within 3 months or a history of recurrent or chronic infection or Risk for TB.
A history of any medical condition specifically related to the use of hormonal contraceptives as well as an average intake of more than 21 units of alcohol per week.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Altasciences Los Angeles (Formerly WCCT Global)		Cypress	California	90630	United States

References Module

Citations

Not provided

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source
Investigator Inquiry Form