LupusPhase 1NCT04065932
A Study to Determine the Pharmacokinetic Profile of BMS-986165 Tablets
A Phase 1 study testing BMS-986165-01, BMS-986165 Tablet and Famotidine in people with Lupus, run by Bristol-Myers Squibb at 1 site in United Kingdom.
Trial summary
A Study to Determine the Drug Level Profile of Different formulations of BMS-986165 Tablets Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Lupus
- What is being tested?
- BMS-986165-01, BMS-986165 Tablet and Famotidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Aug 2019to 10 Dec 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients must be willing and able to complete all study-specific procedures and visits
- Healthy patients, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram, and clinical laboratory determinations
- Body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening
- Normal renal function at screening
Who cannot join
- History or presence of chronic bacterial, viral infection, or autoimmune disorder
- Active TB requiring treatment or documented latent TB within the previous 3 years
- Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
- WOCBP (women of childbearing potential) must have negative serum or urine pregnancy test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Determine the Pharmacokinetic Profile of BMS-986165 Administered as Various Solid Dispersion Tablet Formulations in Healthy Subjects
A Study to Determine the Drug Level Profile of Different formulations of BMS-986165 Tablets
- Conditions
- Lupus
- Being tested
- BMS-986165-01, BMS-986165 Tablet, Famotidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986165-01Drug
Participants will receive BMS- 986165 -01 in prototype formulation
BMS-986165 TabletDrug
Participants will receive BMS-986165 in tablet form.
FamotidineDrug
Participants will receive a previously dosed BMS-985165-01 Prototype Tablet at the same dose level following administration of famotidine
| Study group | Role | What they receive |
|---|---|---|
| BMS-985165-01 prototype formulation 1 | Experimental | Not described Receives: Drug: BMS-986165-01 |
| BMS-986165 Tablet | Experimental | Not described Receives: Drug: BMS-986165 Tablet |
| BMS-985165-01 prototype formulation 2 | Experimental | Not described Receives: Drug: BMS-986165-01 |
| BMS-985165-01 prototype formulation 3 | Experimental | Not described Receives: Drug: BMS-986165-01 |
| BMS-985165-01 prototype formulation 3 or 4 | Experimental | Not described Receives: Drug: BMS-986165-01; Drug: Famotidine |
| BMS-985165-01 prototype formulation 3, 4 or 5 | Experimental | Not described Receives: Drug: BMS-986165-01; Drug: Famotidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) for BMS-986165
Measured: Day 1 of treatment
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration- AUC(0-T) for BMS- 986165
Measured: Day 1 of treatment
Area under the plasma concentration-time curve from time zero extrapolated to infinite time- AUC(INF) for BMS-986165
Measured: Day 1 of treatment
Secondary outcomes (9)
Time to maximum observed plasma concentration-(Tmax) for BMS -986165
Measured: Day 1 of treatment
Apparent plasma elimination half-life- (T-HALF) for BMS-986165
Measured: Day 1 of treatment
Area under the concentration-time curve from time zero to 24 hours post- (AUC 0-24) for BMS-986165
Measured: Day 1 of treatment
Apparent clearance -(CL/F) for BMS-986165
Measured: Day 1 of treatment
Concentration observed at 24 hours-(C24) for BMS-986165
Measured: Day 1 of treatment
Concentration observed at 12 hours-(C12) for BMS-986165
Measured: Day 1 of treatment
Incidence of non-serious adverse events(AE's) leading to discontinuation of study therapy.
Measured: Approximately 16 weeks
Incidence of serious adverse events (SAE) leading to discontinuation of study therapy.
Measured: Approximately 16 weeks.
Incidence of adverse events (AEs) leading to discontinuation of study therapy.
Measured: Approximately 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start22 Aug 2019
- Primary completion8 Dec 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LupusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065932
- Sponsor's protocol ID
- IM011-020
- Status last verified
- Jan 2021
- First submitted
- 21 Aug 2019
- Last updated
- 6 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine the Pharmacokinetic Profile of BMS-986165 Administered as Various Solid Dispersion Tablet Formulations in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04065932
- Acronym / sponsor ID
- IM011-020
- Conditions
- Lupus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 8 Dec 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 22 Aug 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 Study to Determine the Drug Level Profile of Different formulations of BMS-986165 Tablets
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| BMS-985165-01 prototype formulation 1 | Experimental | Drug: BMS-986165-01 |
| BMS-986165 Tablet | Experimental | Drug: BMS-986165 Tablet |
| BMS-985165-01 prototype formulation 2 | Experimental | Drug: BMS-986165-01 |
| BMS-985165-01 prototype formulation 3 | Experimental | Drug: BMS-986165-01 |
| BMS-985165-01 prototype formulation 3 or 4 | Experimental | Drug: BMS-986165-01, Drug: Famotidine |
| BMS-985165-01 prototype formulation 3, 4 or 5 | Experimental | Drug: BMS-986165-01, Drug: Famotidine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients must be willing and able to complete all study-specific procedures and visits
- Healthy patients, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram, and clinical laboratory determinations
- Body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening
- Normal renal function at screening
Key exclusion criteria (4 listed)
- History or presence of chronic bacterial, viral infection, or autoimmune disorder
- Active TB requiring treatment or documented latent TB within the previous 3 years
- Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
- WOCBP (women of childbearing potential) must have negative serum or urine pregnancy test.
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-986165-01Participants will receive BMS- 986165 -01 in prototype formulation | Drug | BMS-985165-01 prototype formulation 1, BMS-985165-01 prototype formulation 2, BMS-985165-01 prototype formulation 3, BMS-985165-01 prototype formulation 3 or 4, BMS-985165-01 prototype formulation 3, 4 or 5 |
| BMS-986165 TabletParticipants will receive BMS-986165 in tablet form. | Drug | BMS-986165 Tablet |
| FamotidineParticipants will receive a previously dosed BMS-985165-01 Prototype Tablet at the same dose level following administration of famotidine | Drug | BMS-985165-01 prototype formulation 3 or 4, BMS-985165-01 prototype formulation 3, 4 or 5 |
Primary outcome
Maximum observed plasma concentration (Cmax) for BMS-986165
Time frame: Day 1 of treatment
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration- AUC(0-T) for BMS- 986165
Time frame: Day 1 of treatment
Area under the plasma concentration-time curve from time zero extrapolated to infinite time- AUC(INF) for BMS-986165
Time frame: Day 1 of treatment
9 secondary outcomes
Time to maximum observed plasma concentration-(Tmax) for BMS -986165
Time frame: Day 1 of treatment
Apparent plasma elimination half-life- (T-HALF) for BMS-986165
Time frame: Day 1 of treatment
Area under the concentration-time curve from time zero to 24 hours post- (AUC 0-24) for BMS-986165
Time frame: Day 1 of treatment
Apparent clearance -(CL/F) for BMS-986165
Time frame: Day 1 of treatment
Concentration observed at 24 hours-(C24) for BMS-986165
Time frame: Day 1 of treatment
Concentration observed at 12 hours-(C12) for BMS-986165
Time frame: Day 1 of treatment
Incidence of non-serious adverse events(AE's) leading to discontinuation of study therapy.
Time frame: Approximately 16 weeks
Incidence of serious adverse events (SAE) leading to discontinuation of study therapy.
Time frame: Approximately 16 weeks.
Incidence of adverse events (AEs) leading to discontinuation of study therapy.
Time frame: Approximately 16 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 6 Jan 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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-986165-01, BMS-986165 Tablet and Famotidine in people with Lupus, run by Bristol-Myers Squibb at 1 site in United Kingdom.
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 4 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 6 Jan 2021. 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 Kingdom. 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) for BMS-986165 (time frame: Day 1 of treatment). 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 6 Jan 2021.