Systemic Lupus ErythematosusPhase 1NCT03254784
A Study to Evaluate BMS-986165 Tablet Formulation Relative to BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal and Increased Gastric pH on the BMS-986165 Tablet Formulation
A Phase 1 study testing BMS-986165 Capsule and BMS-986165 Tablet in people with Systemic Lupus Erythematosus and Arthritic Psoriasis, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to evaluate BMS-986165 tablet formulation versus BMS-986165 capsule formulation. This study will also evaluate the effect of a high-fat/ high-calorie meal and increased gastric pH on the BMS-986165 tablet formulation. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus, Arthritic Psoriasis, Psoriasis
- What is being tested?
- BMS-986165 Capsule and BMS-986165 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2017to 15 Nov 2017
- 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
- 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
- Women of childbearing potential not using an effective contraceptive method or are breastfeeding
- Any significant acute or chronic medical illness
- History of chronic headaches, defined as occurring 15 days or more a month, over the previous 3 months
- History of headaches related to caffeine withdrawal, including energy drinks
- History of syncope, orthostatic instability, or recurrent dizziness
- Active TB requiring treatment or documented latent TB within the previous 3 years
- Other protocol defined inclusion/exclusion criteria could apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Open-Label, Single-Dose, Crossover Study To Evaluate the Bioavailability of BMS-986165 Tablet Formulation Relative To BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal And Increased Gastric pH on the Bioavailability of BMS-986165 Tablet Formulation in Healthy Subjects
The purpose of this study is to evaluate BMS-986165 tablet formulation versus BMS-986165 capsule formulation. This study will also evaluate the effect of a high-fat/ high-calorie meal and increased gastric pH on the BMS-986165 tablet formulation.
- Being tested
- BMS-986165 Capsule, BMS-986165 Tablet
- Medical subject headings
- Lupus Erythematosus, Systemic, Arthritis, Psoriatic, Psoriasis, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986165 CapsuleDrug
Oral capsule
BMS-986165 TabletDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Tablet-Capsule Crossover 1 | Experimental | Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations Receives: Drug: BMS-986165 Capsule; Drug: BMS-986165 Tablet |
| Tablet-Capsule Crossover 2 | Experimental | Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations Receives: Drug: BMS-986165 Capsule; Drug: BMS-986165 Tablet |
| Tablet-Capsule Crossover 3 | Experimental | Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations Receives: Drug: BMS-986165 Capsule; Drug: BMS-986165 Tablet |
| Tablet-Capsule Crossover 4 | Experimental | Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations Receives: Drug: BMS-986165 Capsule; Drug: BMS-986165 Tablet |
| Tablet-Capsule Crossover 5 | Experimental | Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations Receives: Drug: BMS-986165 Capsule; Drug: BMS-986165 Tablet |
| Tablet-Capsule Crossover 6 | Experimental | Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations Receives: Drug: BMS-986165 Capsule; Drug: BMS-986165 Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) derived from plasma concentration versus time
Measured: 5 days
AUC from time zero extrapolated to infinity [AUC(INF)] derived from plasma concentration versus time
Measured: 5 days
Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration [AUC(0-T)] derived from plasma concentration versus time
Measured: 5 days
Time of maximum observed plasma concentration (Tmax) derived from plasma concentration versus time
Measured: 5 days
Secondary outcomes (2)
Adverse events measured by incidence
Measured: 26 days
Serious adverse events measured by incidence
Measured: Approximately 55 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start13 Sep 2017
- Primary completion4 Nov 2017
- Study completion15 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 49 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
- NCT03254784
- Sponsor's protocol ID
- IM011-031
- Status last verified
- Feb 2020
- First submitted
- 17 Aug 2017
- Last updated
- 25 Feb 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 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label, Single-Dose, Crossover Study To Evaluate the Bioavailability of BMS-986165 Tablet Formulation Relative To BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal And Increased Gastric pH on the Bioavailability of BMS-986165 Tablet Formulation in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03254784
- Acronym / sponsor ID
- IM011-031
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- 4 Nov 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 18 Aug 2017 (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.
The purpose of this study is to evaluate BMS-986165 tablet formulation versus BMS-986165 capsule formulation. This study will also evaluate the effect of a high-fat/ high-calorie meal and increased gastric pH on the BMS-986165 tablet formulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Tablet-Capsule Crossover 1 | Experimental | Drug: BMS-986165 Capsule, Drug: BMS-986165 TabletVariations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations |
| Tablet-Capsule Crossover 2 | Experimental | Drug: BMS-986165 Capsule, Drug: BMS-986165 TabletVariations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations |
| Tablet-Capsule Crossover 3 | Experimental | Drug: BMS-986165 Capsule, Drug: BMS-986165 TabletVariations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations |
| Tablet-Capsule Crossover 4 | Experimental | Drug: BMS-986165 Capsule, Drug: BMS-986165 TabletVariations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations |
| Tablet-Capsule Crossover 5 | Experimental | Drug: BMS-986165 Capsule, Drug: BMS-986165 TabletVariations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations |
| Tablet-Capsule Crossover 6 | Experimental | Drug: BMS-986165 Capsule, Drug: BMS-986165 TabletVariations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations |
Who may qualify
- Ages
- 18 to 50 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 (7 listed)
- Women of childbearing potential not using an effective contraceptive method or are breastfeeding
- Any significant acute or chronic medical illness
- History of chronic headaches, defined as occurring 15 days or more a month, over the previous 3 months
- History of headaches related to caffeine withdrawal, including energy drinks
- History of syncope, orthostatic instability, or recurrent dizziness
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 CapsuleOral capsule | Drug | Tablet-Capsule Crossover 1, Tablet-Capsule Crossover 2, Tablet-Capsule Crossover 3, Tablet-Capsule Crossover 4, Tablet-Capsule Crossover 5, Tablet-Capsule Crossover 6 |
| BMS-986165 TabletOral tablet | Drug | Tablet-Capsule Crossover 1, Tablet-Capsule Crossover 2, Tablet-Capsule Crossover 3, Tablet-Capsule Crossover 4, Tablet-Capsule Crossover 5, Tablet-Capsule Crossover 6 |
Primary outcome
Maximum observed plasma concentration (Cmax) derived from plasma concentration versus time
Time frame: 5 days
AUC from time zero extrapolated to infinity [AUC(INF)] derived from plasma concentration versus time
Time frame: 5 days
Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration [AUC(0-T)] derived from plasma concentration versus time
Time frame: 5 days
Time of maximum observed plasma concentration (Tmax) derived from plasma concentration versus time
Time frame: 5 days
2 secondary outcomes
Adverse events measured by incidence
Time frame: 26 days
Serious adverse events measured by incidence
Time frame: Approximately 55 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 25 Feb 2020.
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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 Capsule and BMS-986165 Tablet in people with Systemic Lupus Erythematosus and Arthritic Psoriasis, 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 7 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 25 Feb 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) derived from plasma concentration versus time (time frame: 5 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 25 Feb 2020.