- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04016753
A Study Measuring the Effectiveness of BMS-986256 Combined With Oral Contraceptive in Healthy Female Participants
May 26, 2022 updated by: Bristol-Myers Squibb
The Effect of BMS-986256 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Participants
A comparative study of BMS-986256 with a combined oral contraceptive in healthy female participants to determine the effectiveness when taken together
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Cypress, California, United States, 90630
- Altasciences Los Angeles (Formerly WCCT Global)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Monotherapy
|
30 mg(6ml)
1.5 mg Norethindrone and 30ug ethinyl estradiol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum observed plasma Concentration (Cmax) of Norethindrone (NET)
Time Frame: Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
|
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
Time Frame: Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
|
Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
|
Maximum observed plasma Concentration (Cmax) of Ethinyl Estradiol (EE)
Time Frame: Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
|
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)
Time Frame: Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
|
Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of Adverse Events (AEs)
Time Frame: Up to 28 weeks
|
Up to 28 weeks
|
Incidence of Serious Adverse Events (SAEs)
Time Frame: Up to 28 weeks
|
Up to 28 weeks
|
Serology clinical lab assessment of blood
Time Frame: up to 28 weeks
|
up to 28 weeks
|
Hematology clinical lab assessments of blood
Time Frame: up to 28 weeks
|
up to 28 weeks
|
Urinalysis clinical lab assessment
Time Frame: up to 28 weeks
|
up to 28 weeks
|
Vital signs of blood pressure
Time Frame: up to 28 weeks
|
up to 28 weeks
|
Vital signs of body temperature
Time Frame: up to 28 weeks
|
up to 28 weeks
|
Vital signs of respiratory rate
Time Frame: up to 28 weeks
|
up to 28 weeks
|
Number of Participants with abnormal physical examination findings
Time Frame: up to 28 weeks
|
up to 28 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 5, 2019
Primary Completion (Actual)
February 21, 2020
Study Completion (Actual)
February 21, 2020
Study Registration Dates
First Submitted
June 26, 2019
First Submitted That Met QC Criteria
July 10, 2019
First Posted (Actual)
July 11, 2019
Study Record Updates
Last Update Posted (Actual)
May 31, 2022
Last Update Submitted That Met QC Criteria
May 26, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral, Combined
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Contraceptives, Oral, Sequential
- Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Other Study ID Numbers
- IM026-021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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