Healthy ParticipantsPhase 1NCT04016753
A Study Measuring the Effectiveness of BMS-986256 Combined With Oral Contraceptive in Healthy Female Participants
A Phase 1 study testing BMS-986256 and Loestrin in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
A comparative study of BMS-986256 with a combined oral contraceptive in healthy female participants to determine the effectiveness when taken together Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- BMS-986256 and Loestrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2019to 21 Feb 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Altasciences Los Angeles (Formerly WCCT Global)
Cypress, California, 90630
About this study
Official title: 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
- Conditions
- Healthy Participants
- Being tested
- BMS-986256, Loestrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986256Drug
30 mg(6ml)
LoestrinDrug
1.5 mg Norethindrone and 30ug ethinyl estradiol
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy | Experimental | Not described Receives: Drug: BMS-986256; Drug: Loestrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma Concentration (Cmax) of Norethindrone (NET)
Measured: 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
Measured: Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
Maximum observed plasma Concentration (Cmax) of Ethinyl Estradiol (EE)
Measured: 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)
Measured: Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
Secondary outcomes (9)
Incidence of Adverse Events (AEs)
Measured: Up to 28 weeks
Incidence of Serious Adverse Events (SAEs)
Measured: Up to 28 weeks
Serology clinical lab assessment of blood
Measured: up to 28 weeks
Hematology clinical lab assessments of blood
Measured: up to 28 weeks
Urinalysis clinical lab assessment
Measured: up to 28 weeks
Vital signs of blood pressure
Measured: up to 28 weeks
Vital signs of body temperature
Measured: up to 28 weeks
Vital signs of respiratory rate
Measured: up to 28 weeks
Number of Participants with abnormal physical examination findings
Measured: up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start5 Aug 2019
- Primary completion21 Feb 2020
- Study completion21 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016753
- Sponsor's protocol ID
- IM026-021
- Status last verified
- May 2022
- First submitted
- 26 Jun 2019
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of BMS-986256 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Participants
- ClinicalTrials.gov ID
- NCT04016753
- Acronym / sponsor ID
- IM026-021
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 21 Feb 2020 (actual)
- Study completion
- 21 Feb 2020 (actual)
- First posted
- 11 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A comparative study of BMS-986256 with a combined oral contraceptive in healthy female participants to determine the effectiveness when taken together
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monotherapy | Experimental | Drug: BMS-986256, Drug: Loestrin |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-98625630 mg(6ml) | Drug | Monotherapy |
| Loestrin1.5 mg Norethindrone and 30ug ethinyl estradiol | Drug | Monotherapy |
Primary outcome
Maximum observed plasma Concentration (Cmax) of Norethindrone (NET)
Time frame: 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)
Maximum observed plasma Concentration (Cmax) of Ethinyl Estradiol (EE)
Time frame: 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)
9 secondary outcomes
Incidence of Adverse Events (AEs)
Time frame: Up to 28 weeks
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 28 weeks
Serology clinical lab assessment of blood
Time frame: up to 28 weeks
Hematology clinical lab assessments of blood
Time frame: up to 28 weeks
Urinalysis clinical lab assessment
Time frame: up to 28 weeks
Vital signs of blood pressure
Time frame: up to 28 weeks
Vital signs of body temperature
Time frame: up to 28 weeks
Vital signs of respiratory rate
Time frame: up to 28 weeks
Number of Participants with abnormal physical examination findings
Time frame: up to 28 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986256 and Loestrin in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma Concentration (Cmax) of Norethindrone (NET) (time frame: Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.