Healthy ParticipantsPhase 1NCT04882150
A Study to Determine the Safety, Drug Levels and Drug Effects of BMS-986196 and Food and Formulation Effects on Relative Absorption Healthy Participants
A Phase 1 study testing BMS-986196 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 characterize the safety, tolerability, drug levels and drug effects of BMS-986196 in healthy participants. In addition, an evaluation of food and formulation effects on BMS-986196 absorption will be performed. 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-986196
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2021to 10 Jun 2022
- 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
- Women not of childbearing potential and men, ages 18 or local age of majority to 55 years, inclusive
- Healthy male and female non-Japanese participants without clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECG), and clinical laboratory determinations
- Body mass index (BMI) of 18 to 32 kg/m2, inclusive, and total body weight ≥ 50 kg
Who cannot join
- Known or suspected autoimmune disorder, including but not limited to rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, polymyalgia rheumatica, giant cell arteritis, Behcet's disease, dermatomyositis, MS, moderate to severe asthma, any autoimmune vasculitis, autoimmune hepatitis, or any other active autoimmune disease for which a participant requires medical follow-up or medical treatment
- Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
- Presence of any factors that would predispose the participant to develop infection
- A history of bacterial or fungal meningitis within 1 year prior to screening
- A history of intracranial or intraspinal bleeding
- Known intracranial space-occupying mass, including meningioma
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Local Institution - 0002
Salt Lake City, Utah, 84124
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986196 in Healthy Participants Including an Open-label Assessment of Food and Formulation Effects on the Relative Bioavailability of BMS-986196
The purpose of this study is to characterize the safety, tolerability, drug levels and drug effects of BMS-986196 in healthy participants. In addition, an evaluation of food and formulation effects on BMS-986196 absorption will be performed.
- Conditions
- Healthy Participants
- Being tested
- BMS-986196, Placebo
- Keywords
- Healthy participants, BMS-986196
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986196Drug
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. Each participant will receive a single dose of BMS-986196 or placebo. Receives: Drug: BMS-986196; Other: Placebo |
| Part B: MAD | Experimental | MAD = multiple ascending dose. Each participant will receive multiple doses of BMS-986196 or placebo. Receives: Drug: BMS-986196; Other: Placebo |
| Part C: FE/Formul. | Experimental | FE/Formul. = food and formulation effects and relative absorption. Participants will receive two formulations of BMS-986196 (solution and suspension), each formulation with and without food. Receives: Drug: BMS-986196 |
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 24 days
Severity of AEs
Measured: Up to 24 days
Causality of AEs
Measured: Up to 24 days
Incidence of Serious Adverse Events (SAEs)
Measured: Up to 59 days
Severity of SAEs
Measured: Up to 59 days
Causality of SAEs
Measured: Up to 59 days
Incidence of clinically significant changes in vital signs: Body temperature
Measured: Up to 24 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Measured: Up to 24 days
Incidence of clinically significant changes in vital signs: Blood pressure
Measured: Up to 24 days
Incidence of clinically significant changes in vital signs: Heart rate
Measured: Up to 24 days
Incidence of clinically significant changes in weight
Measured: Up to 24 days
Incidence of clinically significant changes in physical examination
Measured: Up to 24 days
Incidence of clinically significant changes in ECG parameters: QT interval
Measured: Up to 24 days
Incidence of clinically significant changes in ECG parameters: HR
Measured: Up to 24 days
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Measured: Up to 24 days
Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests
Measured: Up to 24 days
Incidence of clinically significant changes in clinical laboratory values: Coagulation tests
Measured: Up to 24 days
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
Measured: Up to 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start27 May 2021
- Primary completion10 Jun 2022
- Study completion10 Jun 2022
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 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
- NCT04882150
- Sponsor's protocol ID
- IM038-008
- Status last verified
- Jan 2023
- First submitted
- 6 May 2021
- Last updated
- 12 Jan 2023
- 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 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986196 in Healthy Participants Including an Open-label Assessment of Food and Formulation Effects on the Relative Bioavailability of BMS-986196
- ClinicalTrials.gov ID
- NCT04882150
- Acronym / sponsor ID
- IM038-008
- Conditions
- Healthy Participants
- Keywords
- Healthy participants, BMS-986196
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 27 May 2021 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 11 May 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 characterize the safety, tolerability, drug levels and drug effects of BMS-986196 in healthy participants. In addition, an evaluation of food and formulation effects on BMS-986196 absorption will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A: SAD | Experimental | Drug: BMS-986196, Other: PlaceboSAD = single ascending dose. Each participant will receive a single dose of BMS-986196 or placebo. |
| Part B: MAD | Experimental | Drug: BMS-986196, Other: PlaceboMAD = multiple ascending dose. Each participant will receive multiple doses of BMS-986196 or placebo. |
| Part C: FE/Formul. | Experimental | Drug: BMS-986196FE/Formul. = food and formulation effects and relative absorption. Participants will receive two formulations of BMS-986196 (solution and suspension), each formulation with and without food. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women not of childbearing potential and men, ages 18 or local age of majority to 55 years, inclusive
- Healthy male and female non-Japanese participants without clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECG), and clinical laboratory determinations
- Body mass index (BMI) of 18 to 32 kg/m2, inclusive, and total body weight ≥ 50 kg
Key exclusion criteria (7 listed)
- Known or suspected autoimmune disorder, including but not limited to rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, polymyalgia rheumatica, giant cell arteritis, Behcet's disease, dermatomyositis, MS, moderate to severe asthma, any autoimmune vasculitis, autoimmune hepatitis, or any other active autoimmune disease for which a participant requires medical follow-up or medical treatment
- Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
- Presence of any factors that would predispose the participant to develop infection
- A history of bacterial or fungal meningitis within 1 year prior to screening
- A history of intracranial or intraspinal bleeding
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-986196Specified dose on specified days | Drug | Part A: SAD, Part B: MAD, Part C: FE/Formul. |
| PlaceboSpecified dose on specified days | Other | Part A: SAD, Part B: MAD |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: Up to 24 days
Severity of AEs
Time frame: Up to 24 days
Causality of AEs
Time frame: Up to 24 days
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 59 days
Severity of SAEs
Time frame: Up to 59 days
Causality of SAEs
Time frame: Up to 59 days
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 24 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 24 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 24 days
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 24 days
Incidence of clinically significant changes in weight
Time frame: Up to 24 days
Incidence of clinically significant changes in physical examination
Time frame: Up to 24 days
Incidence of clinically significant changes in ECG parameters: QT interval
Time frame: Up to 24 days
Incidence of clinically significant changes in ECG parameters: HR
Time frame: Up to 24 days
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Time frame: Up to 24 days
Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests
Time frame: Up to 24 days
Incidence of clinically significant changes in clinical laboratory values: Coagulation tests
Time frame: Up to 24 days
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
Time frame: Up to 24 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 12 Jan 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink 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-986196 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 12 Jan 2023. 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 Adverse Events (AEs) (time frame: Up to 24 days). The study lists 18 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 12 Jan 2023.