Healthy ParticipantsPhase 1NCT03634995
An Investigational Study to Evaluate the Effects of Experimental Medication BMS-986256 in Healthy Participants
A Phase 1 study testing BMS-986256 in people with Healthy Participants, run by Bristol-Myers Squibb at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the effects of the experimental medication BMS-986256 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- BMS-986256
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Aug 2018to 9 Oct 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
- Weight ≥ 50 kg and body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive at screening
- Participants must not be current users (within 6 months before screening) of tobacco or tobacco- or nicotine-containing products; they must also be willing to refrain from using any of these products during their participation in the study
- A negative QuantiFERON®-TB Gold test result at screening or documentation of a negative result within 3 months before screening
Who cannot join
- Previous participation in the current study or previous exposure within 6 weeks before study drug administration for non-biologics and 12 weeks before study drug administration for biologics
- Inability to tolerate oral medication
- Inability to tolerate venipuncture, or inadequate venous access
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Anaheim Clinical Trials
Anaheim, California, 92801
PRA Health Science KK
Lenexa, Kansas, 66219
About this study
Official title: A Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunologic Effects of BMS-986256, and a Relative Bioavailability Study in Healthy Participants
The purpose of this study is to evaluate the effects of the experimental medication BMS-986256 in healthy participants.
- Conditions
- Healthy Participants
- Being tested
- BMS-986256, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986256Drug
Specified dose on specified days
PlaceboOther
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Single Dose | Experimental | Ascending single doses of BMS-986256 Receives: Drug: BMS-986256; Other: Placebo |
| Multiple Dose | Experimental | Ascending multiple doses of BMS-986256 Receives: Drug: BMS-986256; Other: Placebo |
| Sequential Dose | Experimental | Sequential multiple doses of BMS-986256 Receives: Drug: BMS-986256; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Serious Adverse Events (SAE)
Measured: Up to 46 days
Number of deaths
Measured: Up to 46 days
Number of clinically significant changes in ECG, vital signs, physical examination findings, or clinical laboratory assessments
Measured: Up to 44 days
Number of Adverse Events (AEs) leading to early discontinuation
Measured: Up to 44 days
Maximum concentration (Cmax)
Measured: Up to 44 days
Time of maximum concentration (Tmax)
Measured: Up to 44 days
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-T)]
Measured: Up to 44 days
Area under the plasma concentration-time curve extrapolated to infinity [AUC(INF)]
Measured: Up to 44 days
Secondary outcomes (12)
Terminal elimination rate constant (kel)
Measured: Up to 44 days
Terminal elimination half-life (T-half)
Measured: Up to 44 days
Apparent oral clearance (CL/F)
Measured: Up to 44 days
Metabolite ratio for AUC(INF) [MR(AUC[INF])]
Measured: Up to 44 days
Metabolite ratio of Cmax [MR(Cmax)]
Measured: Up to 44 days
Apparent volume of distribution at terminal phase (Vz/F)
Measured: Up to 44 days
Plasma concentration immediately prior to dosing (Ctrough)
Measured: Up to 44 days
Area under the plasma concentration-time curve over the dosing interval [AUC(TAU)]
Measured: Up to 44 days
Accumulation ratio of Ctrough [AR(Ctrough)]
Measured: Up to 44 days
Accumulation ratio of AUC(TAU) [AR(AUC[TAU])]
Measured: Up to 44 days
Accumulation ratio of Cmax [AR(Cmax)]
Measured: Up to 44 days
Metabolite ratio for AUC(TAU) [MR(AUC[TAU])]
Measured: Up to 44 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start14 Aug 2018
- Primary completion9 Oct 2019
- Study completion9 Oct 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 118 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
- NCT03634995
- Sponsor's protocol ID
- IM026-002
- Other IDs
- 2017-003729-13, 2017
- Status last verified
- Jun 2020
- First submitted
- 15 Aug 2018
- Last updated
- 16 Jun 2020
- 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 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunologic Effects of BMS-986256, and a Relative Bioavailability Study in Healthy Participants
- ClinicalTrials.gov ID
- NCT03634995
- Acronym / sponsor ID
- IM026-002
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 9 Oct 2019 (actual)
- Study completion
- 9 Oct 2019 (actual)
- First posted
- 17 Aug 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 evaluate the effects of the experimental medication BMS-986256 in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Dose | Experimental | Drug: BMS-986256, Other: PlaceboAscending single doses of BMS-986256 |
| Multiple Dose | Experimental | Drug: BMS-986256, Other: PlaceboAscending multiple doses of BMS-986256 |
| Sequential Dose | Experimental | Drug: BMS-986256, Other: PlaceboSequential multiple doses of BMS-986256 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Weight ≥ 50 kg and body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive at screening
- Participants must not be current users (within 6 months before screening) of tobacco or tobacco- or nicotine-containing products; they must also be willing to refrain from using any of these products during their participation in the study
- A negative QuantiFERON®-TB Gold test result at screening or documentation of a negative result within 3 months before screening
Key exclusion criteria (4 listed)
- Previous participation in the current study or previous exposure within 6 weeks before study drug administration for non-biologics and 12 weeks before study drug administration for biologics
- Inability to tolerate oral medication
- Inability to tolerate venipuncture, or inadequate venous access
- 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-986256Specified dose on specified days | Drug | Multiple Dose, Sequential Dose, Single Dose |
| PlaceboSpecified dose on specified days | Other | Multiple Dose, Sequential Dose, Single Dose |
Primary outcome
Number of Serious Adverse Events (SAE)
Time frame: Up to 46 days
Number of deaths
Time frame: Up to 46 days
Number of clinically significant changes in ECG, vital signs, physical examination findings, or clinical laboratory assessments
Time frame: Up to 44 days
Number of Adverse Events (AEs) leading to early discontinuation
Time frame: Up to 44 days
Maximum concentration (Cmax)
Time frame: Up to 44 days
Time of maximum concentration (Tmax)
Time frame: Up to 44 days
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-T)]
Time frame: Up to 44 days
Area under the plasma concentration-time curve extrapolated to infinity [AUC(INF)]
Time frame: Up to 44 days
12 secondary outcomes
Terminal elimination rate constant (kel)
Time frame: Up to 44 days
Terminal elimination half-life (T-half)
Time frame: Up to 44 days
Apparent oral clearance (CL/F)
Time frame: Up to 44 days
Metabolite ratio for AUC(INF) [MR(AUC[INF])]
Time frame: Up to 44 days
Metabolite ratio of Cmax [MR(Cmax)]
Time frame: Up to 44 days
Apparent volume of distribution at terminal phase (Vz/F)
Time frame: Up to 44 days
Plasma concentration immediately prior to dosing (Ctrough)
Time frame: Up to 44 days
Area under the plasma concentration-time curve over the dosing interval [AUC(TAU)]
Time frame: Up to 44 days
Accumulation ratio of Ctrough [AR(Ctrough)]
Time frame: Up to 44 days
Accumulation ratio of AUC(TAU) [AR(AUC[TAU])]
Time frame: Up to 44 days
Accumulation ratio of Cmax [AR(Cmax)]
Time frame: Up to 44 days
Metabolite ratio for AUC(TAU) [MR(AUC[TAU])]
Time frame: Up to 44 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 16 Jun 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
2 sites 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 in people with Healthy Participants, run by Bristol-Myers Squibb at 2 sites 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 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Number of Serious Adverse Events (SAE) (time frame: Up to 46 days). The study lists 8 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 16 Jun 2020.