Healthy ParticipantsPhase 1NCT04175925
A Study Assessing the Drug Levels, Drug Effects, and Safety of BMS-986322 in Healthy Participants
A Phase 1 study testing BMS-986322 and famotidine in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
A Study assessing the drug levels and drug effects of variable doses of BMS-986322 in Healthy Participants compared to a placebo. The study also assesses how BMS-986322 affects the body with food and its acidity levels. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- BMS-986322 and famotidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 171 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2019to 13 Jul 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- Body mass index (BMI) of 18.0 kg/m^2 to 32.0 kg/m^2, inclusive, and body weight ≥ 50 kg, at screening
- Women and men must agree to follow methods of contraception.
Who cannot join
- Any significant acute or chronic medical illness
- History of recent infection
- History of allergy to BMS-986322 or other compounds
- Other protocol-defined inclusion/exclusion criteria could apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo-controlled, Randomized, Single and Multiple Ascending Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-986322 in Healthy Participants Including an Open-label Assessment of Food and pH Effects on Relative Bioavailability of BMS-986322
A Study assessing the drug levels and drug effects of variable doses of BMS-986322 in Healthy Participants compared to a placebo. The study also assesses how BMS-986322 affects the body with food and its acidity levels.
Read the detailed description
Recruitment temporarily on hold due to COVID-19.
This is a randomized, double-blind, placebo-controlled study which will investigate the safety, tolerability, and PK of single and multiple oral doses of BMS-986322 in healthy subjects. The trial consists of three parts: Part A - a single ascending dose (SAD) safety and pharmacokinetic (PK) evaluation; Part B -a multiple ascending dose (MAD) safety, PK, and pharmacodynamic (PD) evaluation; and Part C - effect of food and pH on PK and safety.
- Conditions
- Healthy Participants
- Being tested
- BMS-986322, BMS-986322 Placebo, famotidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986322Drug
Specified Dose on Specified Days
BMS-986322 PlaceboOther
Specified Dose on Specified Days
famotidineDrug
Specified Dose on Specified Days
| Study group | Role | What they receive |
|---|---|---|
| Part A: BMS-986322 | Experimental | Not described Receives: Drug: BMS-986322; Other: BMS-986322 Placebo |
| Part B: BMS-986322 Placebo | Experimental | Not described Receives: Drug: BMS-986322; Other: BMS-986322 Placebo |
| Part C: BMS-986322 with famotidine | Experimental | Not described Receives: Drug: BMS-986322; Drug: famotidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Death
Measured: up to 12 months
Incidence of Adverse Effects (AEs)
Measured: up to 12 months
Incidence of Adverse Events leading to discontinuation
Measured: up to 12 months
Incidence of Serious Adverse Events (SAEs)
Measured: up to 12 months
Vital signs of body temperature
Measured: up to 12 months
Vital signs of blood pressure
Measured: up to 12 months
Vital signs of respiratory rate
Measured: up to 12 months
Number of Participants with abnormal physical examinations
Measured: up to 12 months
Number of clinically significant changes in Electrocardiograms (ECGs)
Measured: up to 12 months
Number of clinically significant changes in lab assessment of blood serum
Measured: up to 12 months
Number of clinically significant changes in lab assessment of urine
Measured: up to 12 months
Number of Clinically significant changes in lab assessment of blood
Measured: up to 12 months
Maximum concentration (Cmax) of BMS-986322 in Part C
Measured: up to 12 months
Time of maximum concentration (Tmax) of BMS-986322 in Part C
Measured: up to 12 months
Terminal elimination rate constant (Lambda_z) of BMS-986322 in Part C
Measured: up to 12 months
Terminal elimination half-life (T-Half) of BMS-986322 in Part C
Measured: up to 12 months
Area under the plasma concentration-time curve extrapolated to infinity [AUC(INF)] of BMS-986322 in Part C
Measured: up to 12 months
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-T)] of BMS-986322 in Part C
Measured: up to 12 months
Apparent oral clearance (CL/F) of BMS-986322 in Part C
Measured: up to 12 months
Apparent volume of distrubution at terminal phase (Vz/F) of BMS-986322 in Part C
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start15 Nov 2019
- Primary completion13 Jul 2021
- Study completion13 Jul 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 171 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
- NCT04175925
- Sponsor's protocol ID
- IM032-007
- Status last verified
- May 2022
- First submitted
- 13 Nov 2019
- Last updated
- 31 May 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 31 May 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, Pharmacokinetics, and Pharmacodynamics of BMS-986322 in Healthy Participants Including an Open-label Assessment of Food and pH Effects on Relative Bioavailability of BMS-986322
- ClinicalTrials.gov ID
- NCT04175925
- Acronym / sponsor ID
- IM032-007
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 13 Jul 2021 (actual)
- First posted
- 25 Nov 2019 (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.
A Study assessing the drug levels and drug effects of variable doses of BMS-986322 in Healthy Participants compared to a placebo. The study also assesses how BMS-986322 affects the body with food and its acidity levels.
Detailed description
Recruitment temporarily on hold due to COVID-19.
This is a randomized, double-blind, placebo-controlled study which will investigate the safety, tolerability, and PK of single and multiple oral doses of BMS-986322 in healthy subjects. The trial consists of three parts: Part A - a single ascending dose (SAD) safety and pharmacokinetic (PK) evaluation; Part B -a multiple ascending dose (MAD) safety, PK, and pharmacodynamic (PD) evaluation; and Part C - effect of food and pH on PK and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A: BMS-986322 | Experimental | Drug: BMS-986322, Other: BMS-986322 Placebo |
| Part B: BMS-986322 Placebo | Experimental | Drug: BMS-986322, Other: BMS-986322 Placebo |
| Part C: BMS-986322 with famotidine | Experimental | Drug: BMS-986322, Drug: famotidine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- Body mass index (BMI) of 18.0 kg/m^2 to 32.0 kg/m^2, inclusive, and body weight ≥ 50 kg, at screening
- Women and men must agree to follow methods of contraception.
Key exclusion criteria (4 listed)
- Any significant acute or chronic medical illness
- History of recent infection
- History of allergy to BMS-986322 or other compounds
- 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-986322Specified Dose on Specified Days | Drug | Part A: BMS-986322, Part B: BMS-986322 Placebo, Part C: BMS-986322 with famotidine |
| BMS-986322 PlaceboSpecified Dose on Specified Days | Other | Part A: BMS-986322, Part B: BMS-986322 Placebo |
| famotidineSpecified Dose on Specified Days | Drug | Part C: BMS-986322 with famotidine |
Primary outcome
Incidence of Death
Time frame: up to 12 months
Incidence of Adverse Effects (AEs)
Time frame: up to 12 months
Incidence of Adverse Events leading to discontinuation
Time frame: up to 12 months
Incidence of Serious Adverse Events (SAEs)
Time frame: up to 12 months
Vital signs of body temperature
Time frame: up to 12 months
Vital signs of blood pressure
Time frame: up to 12 months
Vital signs of respiratory rate
Time frame: up to 12 months
Number of Participants with abnormal physical examinations
Time frame: up to 12 months
Number of clinically significant changes in Electrocardiograms (ECGs)
Time frame: up to 12 months
Number of clinically significant changes in lab assessment of blood serum
Time frame: up to 12 months
Number of clinically significant changes in lab assessment of urine
Time frame: up to 12 months
Number of Clinically significant changes in lab assessment of blood
Time frame: up to 12 months
Maximum concentration (Cmax) of BMS-986322 in Part C
Time frame: up to 12 months
Time of maximum concentration (Tmax) of BMS-986322 in Part C
Time frame: up to 12 months
Terminal elimination rate constant (Lambda_z) of BMS-986322 in Part C
Time frame: up to 12 months
Terminal elimination half-life (T-Half) of BMS-986322 in Part C
Time frame: up to 12 months
Area under the plasma concentration-time curve extrapolated to infinity [AUC(INF)] of BMS-986322 in Part C
Time frame: up to 12 months
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-T)] of BMS-986322 in Part C
Time frame: up to 12 months
Apparent oral clearance (CL/F) of BMS-986322 in Part C
Time frame: up to 12 months
Apparent volume of distrubution at terminal phase (Vz/F) of BMS-986322 in Part C
Time frame: up to 12 months
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 31 May 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-986322 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 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 31 May 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 Death (time frame: up to 12 months). The study lists 20 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 31 May 2022.