Healthy ParticipantsPhase 1NCT04113668
The Effects Diflunisal on the Levels of BMS-986165 in Healthy Participants
A Phase 1 study testing BMS-986165 and diflunisal in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
BMS-986165 Is broken down by the body through multiple pathways. This study Investigates the effect of blocking one pathway in the drug levels of BMS-986165 in health subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- BMS-986165 and diflunisal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 25 Nov 2019
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women and men must agree to follow instructions for methods of contraception.
- Participants must be willing and able to complete all study-specific procedures and visits.
- A healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
- WOCBP must have a negative serum or urine pregnancy test within 24 hours prior to the start of study treatment.
Who cannot join
- Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of active liver disease
- History of biliary disorders, including Gilbert's syndrome or Dubin- Johnson disease, in addition to, current or recent gastrointestinal disease that could impact the absorption of study drug.
- Participants using electronic cigarettes or nicotine-containing products who have stopped smoking less than 6 months prior to dosing on Day 1.
- Consumption of chargrilled meat, quinine, or any nutrient known to modulate CYP enzyme activity within 14 days prior to first administration of study treatment.
- History of any significant drug allergy
- Other inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AN OPEN-LABEL, SINGLE-SEQUENCE, CROSSOVER STUDY TO INVESTIGATE THE EFFECTS OF UGT1A9 INHIBITOR DIFLUNISAL, AT STEADY-STATE, ON PHARMACOKINETICS OF A SINGLE DOSE OF BMS-986165 IN HEALTHY MALE AND FEMALE VOLUNTEERS
BMS-986165 Is broken down by the body through multiple pathways. This study Investigates the effect of blocking one pathway in the drug levels of BMS-986165 in health subjects.
- Conditions
- Healthy Participants
- Being tested
- BMS-986165, diflunisal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986165Drug
Specified Dose on Specified Days
diflunisalDrug
Specified Dose on Specified Days
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Single Dose (BMS-986165) | Experimental | Not described Receives: Drug: BMS-986165 |
| Arm B:Diflunisal and Single Dose (BMS-986165) | Experimental | Not described Receives: Drug: BMS-986165; Drug: diflunisal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of BMS-986165 with and without UGT1A9 inhibitor
Measured: Up to 14 days
Area under the plasma concentration-time AUC (0-T) of BMS-986165 with and without UGT1A9 inhibitor
Measured: up to 14 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF) for BMS-986165 with and without UGT1A9 inhibitor
Measured: up to 14 days
Secondary outcomes (9)
Incidence of Adverse Events (AEs)
Measured: up to 48 days
Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities
Measured: up to 48 days
Physical Examination of weight
Measured: up to 48 days
Number of changes in blood pressure
Measured: up to 20 days
Number of changes in body temperature
Measured: up to 20 days
Number of changes in respiratory rate
Measured: up to 20 days
Number of clinical significant changes in lab assessment of blood serum
Measured: up to 48 days
Number of Clinically significant changes in assessment of blood
Measured: up to 20 days
Number of Clinically significant changes in lab assessment of urine
Measured: up to 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start1 Oct 2019
- Primary completion19 Nov 2019
- Study completion25 Nov 2019
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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 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
- NCT04113668
- Sponsor's protocol ID
- IM011-101
- Status last verified
- Aug 2020
- First submitted
- 1 Oct 2019
- Last updated
- 5 Aug 2020
- 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 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AN OPEN-LABEL, SINGLE-SEQUENCE, CROSSOVER STUDY TO INVESTIGATE THE EFFECTS OF UGT1A9 INHIBITOR DIFLUNISAL, AT STEADY-STATE, ON PHARMACOKINETICS OF A SINGLE DOSE OF BMS-986165 IN HEALTHY MALE AND FEMALE VOLUNTEERS
- ClinicalTrials.gov ID
- NCT04113668
- Acronym / sponsor ID
- IM011-101
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 19 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 3 Oct 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.
BMS-986165 Is broken down by the body through multiple pathways. This study Investigates the effect of blocking one pathway in the drug levels of BMS-986165 in health subjects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Single Dose (BMS-986165) | Experimental | Drug: BMS-986165 |
| Arm B:Diflunisal and Single Dose (BMS-986165) | Experimental | Drug: BMS-986165, Drug: diflunisal |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women and men must agree to follow instructions for methods of contraception.
- Participants must be willing and able to complete all study-specific procedures and visits.
- A healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
- WOCBP must have a negative serum or urine pregnancy test within 24 hours prior to the start of study treatment.
Key exclusion criteria (6 listed)
- Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of active liver disease
- History of biliary disorders, including Gilbert's syndrome or Dubin- Johnson disease, in addition to, current or recent gastrointestinal disease that could impact the absorption of study drug.
- Participants using electronic cigarettes or nicotine-containing products who have stopped smoking less than 6 months prior to dosing on Day 1.
- Consumption of chargrilled meat, quinine, or any nutrient known to modulate CYP enzyme activity within 14 days prior to first administration of study treatment.
- History of any significant drug allergy
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-986165Specified Dose on Specified Days | Drug | Arm A: Single Dose (BMS-986165), Arm B:Diflunisal and Single Dose (BMS-986165) |
| diflunisalSpecified Dose on Specified Days | Drug | Arm B:Diflunisal and Single Dose (BMS-986165) |
Primary outcome
Maximum observed plasma concentration (Cmax) of BMS-986165 with and without UGT1A9 inhibitor
Time frame: Up to 14 days
Area under the plasma concentration-time AUC (0-T) of BMS-986165 with and without UGT1A9 inhibitor
Time frame: up to 14 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF) for BMS-986165 with and without UGT1A9 inhibitor
Time frame: up to 14 days
9 secondary outcomes
Incidence of Adverse Events (AEs)
Time frame: up to 48 days
Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities
Time frame: up to 48 days
Physical Examination of weight
Time frame: up to 48 days
Number of changes in blood pressure
Time frame: up to 20 days
Number of changes in body temperature
Time frame: up to 20 days
Number of changes in respiratory rate
Time frame: up to 20 days
Number of clinical significant changes in lab assessment of blood serum
Time frame: up to 48 days
Number of Clinically significant changes in assessment of blood
Time frame: up to 20 days
Number of Clinically significant changes in lab assessment of urine
Time frame: up to 20 days
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 5 Aug 2020.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink 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-986165 and diflunisal 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 4 inclusion and 6 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 5 Aug 2020. 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 BMS-986165 with and without UGT1A9 inhibitor (time frame: Up to 14 days). The study lists 3 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 5 Aug 2020.