Healthy ParticipantsPhase 1NCT04926051
A Study to Assess the Safety, Tolerability and Drug Levels of BMS-986172 in Healthy and Obese Participants, Including an Assessment of the Effects of Food on BMS-986172 Absorption
A Phase 1 study testing BMS-986172 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 evaluate the safety, tolerability and drug levels of BMS-986172 and evaluate the effects of food on BMS-986172 absorption. 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-986172
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2021to 28 Dec 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 as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, ECG, and clinical laboratory results as determined by the investigator or designee.
- Participants in Part C must be first-generation Japanese participants. For the purpose of this study, first-generation Japanese is defined as native Japanese or first-generation Japanese living outside of Japan for <10 years.
- BMI of ≥ 18 kg/m2 to ≤ 40.0 kg/m2, inclusive, at screening, except for high BMI cohort participants (Part B) which will be restricted to a BMI range of ≥ 30 kg/m2 to ≤ 40.0 kg/m2.
Who cannot join
- Inability to tolerate the oral lipid meal or the testing conditions on Day -1, including but not limited to: bloating, nausea, vomiting, diarrhea, pain, or any discomfort due to oral lipid meal.
- Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome.
- History or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator or designee.
- Any significant acute or chronic medical illness.
- History of SARS-CoV-2 infection (either suspected or confirmed) within 3 months prior to signing consent
- Participants who have received a SARS-CoV-2 vaccine approved for Emergency Use Authorization by the US FDA that is not live attenuated may be considered for enrollment
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-blind, Placebo-controlled, Randomized, Single and Multiple Ascending Dose, and a Japanese Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-986172, Including an Open-Label Assessment of Relative Bioavailability and Food Effect on the Single-Dose Pharmacokinetics of BMS-986172 in Healthy and Obese Otherwise Healthy Participants
The purpose of this study is to evaluate the safety, tolerability and drug levels of BMS-986172 and evaluate the effects of food on BMS-986172 absorption.
- Conditions
- Healthy Participants
- Being tested
- BMS-986172, Placebo
- Keywords
- Healthy Participants, BMS-986172
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986172Drug
Specified dose on specified days
PlaceboOther
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part A: SAD | Experimental | SAD = Single Ascending Dose Receives: Drug: BMS-986172; Other: Placebo |
| Part B: MAD | Experimental | MAD = Multiple Ascending Dose Receives: Drug: BMS-986172; Other: Placebo |
| Part C: JMAD | Experimental | JMAD= Japanese Multiple Ascending Dose Receives: Drug: BMS-986172; Other: Placebo |
| Part D: FE/BA | Experimental | FE/BA = Food Effect/Relative Bioavailability Receives: Drug: BMS-986172 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of non-serious Adverse Events (AEs)
Measured: Up to 35 days
Incidence of Serious Adverse Events (SAEs)
Measured: Up to 35 days
Incidence of AEs leading to discontinuation of study treatment
Measured: Up to 35 days
Incidence of clinically significant changes in vital signs: Body temperature
Measured: Up to 28 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Measured: Up to 28 days
Incidence of clinically significant changes in vital signs: Blood pressure
Measured: Up to 28 days
Incidence of clinically significant changes in vital signs: Heart rate
Measured: Up to 28 days
Incidence of clinically significant changes in physical examination
Measured: Up to 28 days
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Measured: Up to 28 days
Incidence of clinically significant changes in clinical laboratory values: Chemistry tests
Measured: Up to 28 days
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
Measured: Up to 28 days
Incidence of clinically significant changes in clinical laboratory values: Serology tests
Measured: Up to 28 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 28 days
Secondary outcomes (3)
Plasma concentrations of BMS-986172
Measured: Up to 28 days
Maximum observed plasma concentration (Cmax)
Measured: Up to 28 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start15 Jun 2021
- Primary completion28 Dec 2021
- Study completion28 Dec 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 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
- NCT04926051
- Sponsor's protocol ID
- MB008-009
- Status last verified
- Jun 2022
- First submitted
- 11 Jun 2021
- Last updated
- 6 Jun 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 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind, Placebo-controlled, Randomized, Single and Multiple Ascending Dose, and a Japanese Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-986172, Including an Open-Label Assessment of Relative Bioavailability and Food Effect on the Single-Dose Pharmacokinetics of BMS-986172 in Healthy and Obese Otherwise Healthy Participants
- ClinicalTrials.gov ID
- NCT04926051
- Acronym / sponsor ID
- MB008-009
- Conditions
- Healthy Participants
- Keywords
- Healthy Participants, BMS-986172
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 28 Dec 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 14 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 evaluate the safety, tolerability and drug levels of BMS-986172 and evaluate the effects of food on BMS-986172 absorption.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: SAD | Experimental | Drug: BMS-986172, Other: PlaceboSAD = Single Ascending Dose |
| Part B: MAD | Experimental | Drug: BMS-986172, Other: PlaceboMAD = Multiple Ascending Dose |
| Part C: JMAD | Experimental | Drug: BMS-986172, Other: PlaceboJMAD= Japanese Multiple Ascending Dose |
| Part D: FE/BA | Experimental | Drug: BMS-986172FE/BA = Food Effect/Relative Bioavailability |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy participants as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, ECG, and clinical laboratory results as determined by the investigator or designee.
- Participants in Part C must be first-generation Japanese participants. For the purpose of this study, first-generation Japanese is defined as native Japanese or first-generation Japanese living outside of Japan for <10 years.
- BMI of ≥ 18 kg/m2 to ≤ 40.0 kg/m2, inclusive, at screening, except for high BMI cohort participants (Part B) which will be restricted to a BMI range of ≥ 30 kg/m2 to ≤ 40.0 kg/m2.
Key exclusion criteria (7 listed)
- Inability to tolerate the oral lipid meal or the testing conditions on Day -1, including but not limited to: bloating, nausea, vomiting, diarrhea, pain, or any discomfort due to oral lipid meal.
- Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome.
- History or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator or designee.
- Any significant acute or chronic medical illness.
- History of SARS-CoV-2 infection (either suspected or confirmed) within 3 months prior to signing consent
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-986172Specified dose on specified days | Drug | Part A: SAD, Part B: MAD, Part C: JMAD, Part D: FE/BA |
| PlaceboSpecified dose on specified days | Other | Part A: SAD, Part B: MAD, Part C: JMAD |
Primary outcome
Incidence of non-serious Adverse Events (AEs)
Time frame: Up to 35 days
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 35 days
Incidence of AEs leading to discontinuation of study treatment
Time frame: Up to 35 days
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 28 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 28 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 28 days
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 28 days
Incidence of clinically significant changes in physical examination
Time frame: Up to 28 days
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Time frame: Up to 28 days
Incidence of clinically significant changes in clinical laboratory values: Chemistry tests
Time frame: Up to 28 days
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
Time frame: Up to 28 days
Incidence of clinically significant changes in clinical laboratory values: Serology tests
Time frame: Up to 28 days
Incidence of clinically significant changes in ECG parameters: QTcF
Time frame: Up to 28 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
3 secondary outcomes
Plasma concentrations of BMS-986172
Time frame: Up to 28 days
Maximum observed plasma concentration (Cmax)
Time frame: Up to 28 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
Time frame: Up to 28 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 6 Jun 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.
Related trials for Healthy Participants
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
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-986172 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 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 6 Jun 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?
Incidence of non-serious Adverse Events (AEs) (time frame: Up to 35 days). The study lists 13 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 6 Jun 2022.