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

NCT04016753 | Completed Phase 1 FDA Drug

• 1 other identifier: IM026-021
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (4)

• 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 (9)

• 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

  up to 28 weeks

• Hematology clinical lab assessments of blood

  up to 28 weeks

• Urinalysis clinical lab assessment

  up to 28 weeks

Study Arms (1)

Monotherapy

EXPERIMENTAL

Drug: BMS-986256; Drug: Loestrin

Interventions

BMS-986256 DRUG

30 mg(6ml)

Monotherapy

Loestrin DRUG

1.5 mg Norethindrone and 30ug ethinyl estradiol

Monotherapy

Eligibility Criteria

• Age: 21 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Altasciences Los Angeles (Formerly WCCT Global)

Cypress, California, 90630, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Interventions

norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 11, 2019
• Study Start: August 5, 2019
• Primary Completion: February 21, 2020
• Study Completion: February 21, 2020
• Last Updated: May 31, 2022

Record last verified: 2022-05

Locations

US (1)