Healthy ParticipantsPhase 1NCT04941755
A Study to Determine the Effect of Famotidine on the Drug Levels of BMS-986256 in Healthy Participants
A Phase 1 study testing BMS-986256 and Famotidine 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 effect of gastric pH changes induced by famotidine on the drug levels of BMS-986256. 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 and Famotidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2021to 24 Sep 2021
- 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
- Healthy participants, defined as having no clinically significant deviations from normal in medical history
- Weight ≥ 50 kg and body mass index between 18.0 kg/m2 and 32.0 kg/m2, inclusive, at screening
- Normal renal function at screening
Who cannot join
- Any significant acute or chronic medical illness
- Current or recent gastrointestinal (GI) disease that could impact upon the absorption of study treatment
- Any major surgery within 4 weeks of study treatment administration
- Significant history of GI abnormalities
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Open-label, 2-Period Crossover Study to Assess the Effect of Acid-reducing Agent Famotidine on the Pharmacokinetics of BMS-986256 in Healthy Participants
The purpose of this study is to investigate the effect of gastric pH changes induced by famotidine on the drug levels of BMS-986256.
- Conditions
- Healthy Participants
- Being tested
- BMS-986256, Famotidine
- Keywords
- Healthy Participants, BMS-986256, Famotidine, Gastric pH
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
FamotidineDrug
Also called Pepcid
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Sequence AB | Experimental | Not described Receives: Drug: BMS-986256; Drug: Famotidine |
| Sequence BA | Experimental | Not described Receives: Drug: BMS-986256; Drug: Famotidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of BMS-986256
Measured: Up to 19 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) of BMS-986256
Measured: Up to 19 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986256
Measured: Up to 19 days
Secondary outcomes (20)
Incidence of Adverse Events (AEs)
Measured: Up to 45 days
Incidence of Serious Adverse Events (SAEs)
Measured: Up to 45 days
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Measured: Up to 45 days
Incidence of clinically significant changes in clinical laboratory values: Chemistry tests
Measured: Up to 45 days
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
Measured: Up to 45 days
Incidence of clinically significant changes in vital signs: Body temperature
Measured: Up to 45 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Measured: Up to 45 days
Incidence of clinically significant changes in vital signs: Blood pressure
Measured: Up to 45 days
Incidence of clinically significant changes in vital signs: Heart rate
Measured: Up to 45 days
Incidence of clinically significant changes in Electrocardiogram (ECG) parameters: PR interval
PR interval is the time from the onset of the P wave to the start of the QRS complex
Measured: Up to 45 days
Incidence of clinically significant changes in ECG parameters: QRS
QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
Measured: Up to 45 days
Incidence of clinically significant changes in ECG parameters: QT interval
The QT interval is the time from the start of the Q wave to the end of the T wave
Measured: Up to 45 days
Incidence of clinically significant changes in ECG parameters: QTcF
QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave
Measured: Up to 45 days
Ratio of Cmax of BMS-986256 (with famotidine versus without famotidine)
Measured: Up to 45 days
Ratio of AUC(0-T) of BMS-986256 (with famotidine versus without famotidine)
Measured: Up to 45 days
Ratio of AUC(INF) of BMS-986256 (with famotidine versus without famotidine)
Measured: Up to 45 days
Time of maximum observed plasma concentration (Tmax) of BMS-986256
Measured: Up to 45 days
Apparent terminal plasma half-life (T-HALF) of BMS-986256
Measured: Up to 45 days
Apparent total body clearance (CLT/F) of BMS-986256
Measured: Up to 45 days
Apparent volume of distribution of terminal phase (Vz/F) of BMS-986256
Measured: Up to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start25 Jun 2021
- Primary completion24 Sep 2021
- Study completion24 Sep 2021
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT04941755
- Sponsor's protocol ID
- IM026-029
- Status last verified
- Jan 2022
- First submitted
- 24 Jun 2021
- Last updated
- 21 Jan 2022
- 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 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-label, 2-Period Crossover Study to Assess the Effect of Acid-reducing Agent Famotidine on the Pharmacokinetics of BMS-986256 in Healthy Participants
- ClinicalTrials.gov ID
- NCT04941755
- Acronym / sponsor ID
- IM026-029
- Conditions
- Healthy Participants
- Keywords
- Healthy Participants, BMS-986256, Famotidine, Gastric pH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 24 Sep 2021 (actual)
- Study completion
- 24 Sep 2021 (actual)
- First posted
- 28 Jun 2021 (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 effect of gastric pH changes induced by famotidine on the drug levels of BMS-986256.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence AB | Experimental | Drug: BMS-986256, Drug: Famotidine |
| Sequence BA | Experimental | Drug: BMS-986256, Drug: Famotidine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy participants, defined as having no clinically significant deviations from normal in medical history
- Weight ≥ 50 kg and body mass index between 18.0 kg/m2 and 32.0 kg/m2, inclusive, at screening
- Normal renal function at screening
Key exclusion criteria (5 listed)
- Any significant acute or chronic medical illness
- Current or recent gastrointestinal (GI) disease that could impact upon the absorption of study treatment
- Any major surgery within 4 weeks of study treatment administration
- Significant history of GI abnormalities
- Other protocol-defined inclusion/exclusion criteria 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 | Sequence AB, Sequence BA |
| FamotidineAlso: PepcidSpecified dose on specified days | Drug | Sequence AB, Sequence BA |
Primary outcome
Maximum observed plasma concentration (Cmax) of BMS-986256
Time frame: Up to 19 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) of BMS-986256
Time frame: Up to 19 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986256
Time frame: Up to 19 days
20 secondary outcomes
Incidence of Adverse Events (AEs)
Time frame: Up to 45 days
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 45 days
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Time frame: Up to 45 days
Incidence of clinically significant changes in clinical laboratory values: Chemistry tests
Time frame: Up to 45 days
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
Time frame: Up to 45 days
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 45 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 45 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 45 days
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 45 days
Incidence of clinically significant changes in Electrocardiogram (ECG) parameters: PR interval
Time frame: Up to 45 days
Incidence of clinically significant changes in ECG parameters: QRS
Time frame: Up to 45 days
Incidence of clinically significant changes in ECG parameters: QT interval
Time frame: Up to 45 days
Incidence of clinically significant changes in ECG parameters: QTcF
Time frame: Up to 45 days
Ratio of Cmax of BMS-986256 (with famotidine versus without famotidine)
Time frame: Up to 45 days
Ratio of AUC(0-T) of BMS-986256 (with famotidine versus without famotidine)
Time frame: Up to 45 days
Ratio of AUC(INF) of BMS-986256 (with famotidine versus without famotidine)
Time frame: Up to 45 days
Time of maximum observed plasma concentration (Tmax) of BMS-986256
Time frame: Up to 45 days
Apparent terminal plasma half-life (T-HALF) of BMS-986256
Time frame: Up to 45 days
Apparent total body clearance (CLT/F) of BMS-986256
Time frame: Up to 45 days
Apparent volume of distribution of terminal phase (Vz/F) of BMS-986256
Time frame: Up to 45 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 21 Jan 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Investigator Inquiry FormLink 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-986256 and Famotidine 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 5 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 21 Jan 2022. 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-986256 (time frame: Up to 19 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 21 Jan 2022.