Healthy VolunteersPhase 1NCT04550195
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986337 When Taken by Mouth by Healthy Participants
A Phase 1 study testing BMS-986337 and Famotidine in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in Netherlands.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986337 in healthy participants and in healthy Japanese participants. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BMS-986337 and Famotidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Sep 2020to 3 Mar 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
- For Japanese cohorts in Part C, must be first-generation Japanese (born in Japan, not living outside of Japan for more than 10 years, and both parents are ethnically Japanese)
- Body mass index (BMI) of 18.0 kg/m^2 to 30.0 kg/m^2, inclusive, at screening; BMI = weight (kg)/height (m)^2
- Women and men must agree to follow specific methods of contraception, if applicable
Who cannot join
- Women who are of childbearing potential
- Women who are breastfeeding
- Prior exposure to BMS-986278
- Positive nasopharyngeal reverse transcriptase polymerase chain reaction (RT-PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on Day -2
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
ICON Plc (PRA Health Sciences) - Netherlands
Groningen, 9728 NZ
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study of the Safety and Tolerability, and Pharmacokinetics (Including Food Effect, pH Effect and Japanese Bridging Study) of BMS-986337 Following Oral Administration in Healthy Participants
The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986337 in healthy participants and in healthy Japanese participants.
- Conditions
- Healthy Volunteers
- Being tested
- BMS-986337, BMS-986337 Placebo, Famotidine
- Keywords
- Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986337Drug
Specified Dose on Specified Days
BMS-986337 PlaceboOther
Specified Dose on Specified Days
FamotidineBiological
Specified Dose on Specified Days
| Study group | Role | What they receive |
|---|---|---|
| Part A Single Ascending Dose (SAD) Cohort A1 | Experimental | Not described Receives: Drug: BMS-986337; Other: BMS-986337 Placebo |
| Part A SAD Cohort A2 | Experimental | Not described Receives: Drug: BMS-986337; Other: BMS-986337 Placebo |
| Part A SAD Cohort A3 | Experimental | Not described Receives: Drug: BMS-986337; Other: BMS-986337 Placebo |
| Part A SAD Cohort A4 | Experimental | Not described Receives: Drug: BMS-986337; Other: BMS-986337 Placebo |
| Part A SAD Cohort A5 | Experimental | Not described Receives: Drug: BMS-986337; Other: BMS-986337 Placebo |
| Part A SAD Cohort A6 | Experimental | Not described Receives: Drug: BMS-986337; Biological: Famotidine |
| Part B Multiple Ascending Dose (MAD) Cohort B1 | Experimental | Not described Receives: Drug: BMS-986337; Other: BMS-986337 Placebo |
| Part B MAD Cohort B2 | Experimental | Not described Receives: Drug: BMS-986337; Other: BMS-986337 Placebo |
| Part B MAD Cohort B3 | Experimental | Not described Receives: Drug: BMS-986337; Other: BMS-986337 Placebo |
| Part B MAD Cohort B4 | Experimental | Not described Receives: Drug: BMS-986337; Other: BMS-986337 Placebo |
| Part C MAD in Japanese Healthy participants Cohort C1 | Experimental | Not described Receives: Drug: BMS-986337; Other: BMS-986337 Placebo |
| Part C MAD in Japanese Healthy participants Cohort C2 | Experimental | Not described Receives: Drug: BMS-986337; Other: BMS-986337 Placebo |
| Part C MAD in Japanese Healthy participants Cohort C3 | Experimental | Not described Receives: Drug: BMS-986337; Other: BMS-986337 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Measured: Up to 30 days
Incidence of Serious Adverse Events (SAEs)
Measured: Up to 81 days
Incidence of AEs leading to discontinuation
Measured: Up to 30 days
Number of clinically significant changes in clinical laboratory values: Hematology tests
Measured: Up to 51 days
Number of clinically significant changes in clinical laboratory values: Urinalysis tests
Measured: Up to 51 days
Number of clinically significant changes in clinical laboratory values: Clinical chemistry tests
Measured: Up to 51 days
Number of clinically significant changes from baseline in vital signs: Heart Rate
Measured: Up to 51 days
Number of clinically significant changes from baseline in vital signs: Body Temperature
Measured: Up to 51 days
Number of clinically significant changes from baseline in vital signs: Blood Pressure
Measured: Up to 51 days
Number of clinically significant changes from baseline in vital signs: Respiratory Rate
Measured: Up to 51 days
Number of clinically significant changes in electrocardiogram (ECG) parameters: Heart rate (HR)
Measured: Up to 51 days
Number of clinically significant changes from baseline in physical examinations
Measured: Up to 51 days
Number of clinically significant changes in 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 51 days
Number of clinically significant changes in ECG parameters: QRS duration
QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
Measured: Up to 51 days
Number of clinically significant changes in ECG parameters: QTc-interval (Fridericia's)
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 51 days
Number 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 51 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start17 Sep 2020
- Primary completion3 Mar 2021
- Study completion3 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 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
- NCT04550195
- Sponsor's protocol ID
- IM037-009
- Other IDs
- 2019-004518-32, 2019
- Status last verified
- Feb 2022
- First submitted
- 11 Sep 2020
- Last updated
- 25 Feb 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 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study of the Safety and Tolerability, and Pharmacokinetics (Including Food Effect, pH Effect and Japanese Bridging Study) of BMS-986337 Following Oral Administration in Healthy Participants
- ClinicalTrials.gov ID
- NCT04550195
- Acronym / sponsor ID
- IM037-009
- Conditions
- Healthy Volunteers
- Keywords
- Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 3 Mar 2021 (actual)
- Study completion
- 3 Mar 2021 (actual)
- First posted
- 16 Sep 2020 (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 safety, tolerability, and drug levels of BMS-986337 in healthy participants and in healthy Japanese participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Part A Single Ascending Dose (SAD) Cohort A1 | Experimental | Drug: BMS-986337, Other: BMS-986337 Placebo |
| Part A SAD Cohort A2 | Experimental | Drug: BMS-986337, Other: BMS-986337 Placebo |
| Part A SAD Cohort A3 | Experimental | Drug: BMS-986337, Other: BMS-986337 Placebo |
| Part A SAD Cohort A4 | Experimental | Drug: BMS-986337, Other: BMS-986337 Placebo |
| Part A SAD Cohort A5 | Experimental | Drug: BMS-986337, Other: BMS-986337 Placebo |
| Part A SAD Cohort A6 | Experimental | Drug: BMS-986337, Biological: Famotidine |
| Part B Multiple Ascending Dose (MAD) Cohort B1 | Experimental | Drug: BMS-986337, Other: BMS-986337 Placebo |
| Part B MAD Cohort B2 | Experimental | Drug: BMS-986337, Other: BMS-986337 Placebo |
| Part B MAD Cohort B3 | Experimental | Drug: BMS-986337, Other: BMS-986337 Placebo |
| Part B MAD Cohort B4 | Experimental | Drug: BMS-986337, Other: BMS-986337 Placebo |
| Part C MAD in Japanese Healthy participants Cohort C1 | Experimental | Drug: BMS-986337, Other: BMS-986337 Placebo |
| Part C MAD in Japanese Healthy participants Cohort C2 | Experimental | Drug: BMS-986337, Other: BMS-986337 Placebo |
| Part C MAD in Japanese Healthy participants Cohort C3 | Experimental | Drug: BMS-986337, Other: BMS-986337 Placebo |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
- For Japanese cohorts in Part C, must be first-generation Japanese (born in Japan, not living outside of Japan for more than 10 years, and both parents are ethnically Japanese)
- Body mass index (BMI) of 18.0 kg/m^2 to 30.0 kg/m^2, inclusive, at screening; BMI = weight (kg)/height (m)^2
- Women and men must agree to follow specific methods of contraception, if applicable
Key exclusion criteria (5 listed)
- Women who are of childbearing potential
- Women who are breastfeeding
- Prior exposure to BMS-986278
- Positive nasopharyngeal reverse transcriptase polymerase chain reaction (RT-PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on Day -2
- 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-986337Specified Dose on Specified Days | Drug | Part A SAD Cohort A2, Part A SAD Cohort A3, Part A SAD Cohort A4, Part A SAD Cohort A5, Part A SAD Cohort A6, Part A Single Ascending Dose (SAD) Cohort A1, Part B MAD Cohort B2, Part B MAD Cohort B3, Part B MAD Cohort B4, Part B Multiple Ascending Dose (MAD) Cohort B1, Part C MAD in Japanese Healthy participants Cohort C1, Part C MAD in Japanese Healthy participants Cohort C2, Part C MAD in Japanese Healthy participants Cohort C3 |
| BMS-986337 PlaceboSpecified Dose on Specified Days | Other | Part A SAD Cohort A2, Part A SAD Cohort A3, Part A SAD Cohort A4, Part A SAD Cohort A5, Part A Single Ascending Dose (SAD) Cohort A1, Part B MAD Cohort B2, Part B MAD Cohort B3, Part B MAD Cohort B4, Part B Multiple Ascending Dose (MAD) Cohort B1, Part C MAD in Japanese Healthy participants Cohort C1, Part C MAD in Japanese Healthy participants Cohort C2, Part C MAD in Japanese Healthy participants Cohort C3 |
| FamotidineSpecified Dose on Specified Days | Biological | Part A SAD Cohort A6 |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: Up to 30 days
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 81 days
Incidence of AEs leading to discontinuation
Time frame: Up to 30 days
Number of clinically significant changes in clinical laboratory values: Hematology tests
Time frame: Up to 51 days
Number of clinically significant changes in clinical laboratory values: Urinalysis tests
Time frame: Up to 51 days
Number of clinically significant changes in clinical laboratory values: Clinical chemistry tests
Time frame: Up to 51 days
Number of clinically significant changes from baseline in vital signs: Heart Rate
Time frame: Up to 51 days
Number of clinically significant changes from baseline in vital signs: Body Temperature
Time frame: Up to 51 days
Number of clinically significant changes from baseline in vital signs: Blood Pressure
Time frame: Up to 51 days
Number of clinically significant changes from baseline in vital signs: Respiratory Rate
Time frame: Up to 51 days
Number of clinically significant changes in electrocardiogram (ECG) parameters: Heart rate (HR)
Time frame: Up to 51 days
Number of clinically significant changes from baseline in physical examinations
Time frame: Up to 51 days
Number of clinically significant changes in ECG parameters: PR interval
Time frame: Up to 51 days
PR interval is the time from the onset of the P wave to the start of the QRS complex
Number of clinically significant changes in ECG parameters: QRS duration
Time frame: Up to 51 days
QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
Number of clinically significant changes in ECG parameters: QTc-interval (Fridericia's)
Time frame: Up to 51 days
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.
Number of clinically significant changes in ECG parameters: QT interval
Time frame: Up to 51 days
The QT interval is the time from the start of the Q wave to the end of the T wave.
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 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-986337 and Famotidine in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in Netherlands.
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 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 25 Feb 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 Netherlands. 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?
Incidence of Adverse Events (AEs) (time frame: Up to 30 days). The study lists 16 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 2022.