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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04016753
Recruitment Status : Active, not recruiting
First Posted : July 11, 2019
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Healthy Participants Drug: BMS-986256 Drug: Loestrin Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Effect of BMS-986256 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Participants
Actual Study Start Date : July 3, 2019
Estimated Primary Completion Date : October 20, 2020
Estimated Study Completion Date : October 21, 2020

Arm Intervention/treatment
Experimental: Monotherapy Drug: BMS-986256
30 mg(6ml)

Drug: Loestrin
1.5 mg Norethindrone and 30ug ethinyl estradiol




Primary Outcome Measures :
  1. Maximum observed plasma Concentration (Cmax) of Norethindrone (NET) [ Time Frame: Day 21 of cycle 1 and cycle 2 (each cycle is 28 days) ]
  2. 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) ]
  3. Maximum observed plasma Concentration (Cmax) of Ethinyl Estradiol (EE) [ Time Frame: Day 21 of cycle 1 and cycle 2 (each cycle is 28 days) ]
  4. 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) ]

Secondary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 28 weeks ]
  2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 28 weeks ]
  3. Serology clinical lab assessment of blood [ Time Frame: up to 28 weeks ]
  4. Hematology clinical lab assessments of blood [ Time Frame: up to 28 weeks ]
  5. Urinalysis clinical lab assessment [ Time Frame: up to 28 weeks ]
  6. Vital signs of blood pressure [ Time Frame: up to 28 weeks ]
  7. Vital signs of body temperature [ Time Frame: up to 28 weeks ]
  8. Vital signs of respiratory rate [ Time Frame: up to 28 weeks ]
  9. Number of Participants with abnormal physical examination findings [ Time Frame: up to 28 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016753


Locations
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United States, California
WCCT Global
Cypress, California, United States, 90630
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04016753    
Other Study ID Numbers: IM026-021
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Contraceptive Agents
Norethindrone
Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Contraceptives, Oral
Estradiol
Ethinyl Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral, Combined
Contraceptives, Oral, Hormonal
Contraceptives, Oral, Sequential