Healthy ParticipantsPhase 1NCT03660436
An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants
A Phase 1 study testing BMS-986165 and MMF in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effects of experimental medication BMS-986165 in healthy male participants. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- BMS-986165 and MMF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2018to 18 Oct 2018
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participant, as determined by no clinically significant deviation from normal in physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
- Body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening
- Normal renal function at screening as evidenced by an estimated GFR (glomerular filtration rate) > 80 mL/min/1.732 m2
Who cannot join
- Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease
- Positive anti- John Cunningham virus (JCV) antibody test at Screening
- History of allergy to MMF, BMS-986165, related compounds or any significant drug allergy
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-sequence Study to Investigate the Effects of BMS-986165 at Steady State on the Single Dose Pharmacokinetics of Mycophenolate Mofetil (MMF) in Healthy Male Subjects
The purpose of this study is to investigate the effects of experimental medication BMS-986165 in healthy male participants.
- Conditions
- Healthy Participants
- Being tested
- BMS-986165, MMF
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
MMFDrug
Also called Mycophenolate Mofetil
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| BMS-986165 + MMF | Experimental | Oral administration Receives: Drug: BMS-986165; Drug: MMF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of mycophenolic acid (MPA)
Measured: 18 days
Area under the concentration vs time curve from time zero to the last quantifiable plasma concentration (AUC[0-T]) of MPA
Measured: 18 days
AUC extrapolated to infinity (AUC[INF]) of MPA
Measured: 18 days
Secondary outcomes (4)
Number of adverse events (AE)
Measured: Up to 48 days
Number of serious adverse events (SAE)
Measured: Up to 48 days
Number of AEs leading to discontinuation
Measured: Up to 48 days
Incidence of clinically significant changes in laboratory test results, vital sign measurements, electrocardiograms (ECGs) and physical examination results
Measured: 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start14 Aug 2018
- Primary completion10 Oct 2018
- Study completion18 Oct 2018
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 131 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
- NCT03660436
- Sponsor's protocol ID
- IM011-071
- Status last verified
- Dec 2018
- First submitted
- 4 Sep 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-sequence Study to Investigate the Effects of BMS-986165 at Steady State on the Single Dose Pharmacokinetics of Mycophenolate Mofetil (MMF) in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03660436
- Acronym / sponsor ID
- IM011-071
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 18 Oct 2018 (actual)
- First posted
- 6 Sep 2018 (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 investigate the effects of experimental medication BMS-986165 in healthy male participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMS-986165 + MMF | Experimental | Drug: BMS-986165, Drug: MMFOral administration |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy participant, as determined by no clinically significant deviation from normal in physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
- Body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening
- Normal renal function at screening as evidenced by an estimated GFR (glomerular filtration rate) > 80 mL/min/1.732 m2
Key exclusion criteria (4 listed)
- Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease
- Positive anti- John Cunningham virus (JCV) antibody test at Screening
- History of allergy to MMF, BMS-986165, related compounds or any significant drug allergy
- Other protocol defined inclusion/exclusion criteria could apply
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 | BMS-986165 + MMF |
| MMFAlso: Mycophenolate MofetilSpecified dose on specified days | Drug | BMS-986165 + MMF |
Primary outcome
Maximum plasma concentration (Cmax) of mycophenolic acid (MPA)
Time frame: 18 days
Area under the concentration vs time curve from time zero to the last quantifiable plasma concentration (AUC[0-T]) of MPA
Time frame: 18 days
AUC extrapolated to infinity (AUC[INF]) of MPA
Time frame: 18 days
4 secondary outcomes
Number of adverse events (AE)
Time frame: Up to 48 days
Number of serious adverse events (SAE)
Time frame: Up to 48 days
Number of AEs leading to discontinuation
Time frame: Up to 48 days
Incidence of clinically significant changes in laboratory test results, vital sign measurements, electrocardiograms (ECGs) and physical examination results
Time frame: 18 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 19 Dec 2018.
- 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 MMF 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 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 19 Dec 2018. 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 plasma concentration (Cmax) of mycophenolic acid (MPA) (time frame: 18 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 19 Dec 2018.