Mediators of InflammationPhase 1NCT03335553
A Study of Experimental Medication BMS-986235 in Healthy Subjects
A Phase 1 study testing BMS-986235 in people with Mediators of Inflammation, run by Bristol-Myers Squibb at 2 sites in United States.
Trial summary
This is a study of experimental medication BMS-986235 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Mediators of Inflammation
- What is being tested?
- BMS-986235
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Nov 2017to 2 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients must be normal healthy volunteers as determined by no clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations
- Patients must have a body mass index (BMI) of 18 - 30 mg/kg2, inclusive
Who cannot join
- Patients that are pregnant
- Patient with any significant acute or chronic medical illness
- Patient with a current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
- Patient with any surgery within 12 weeks of study treatment administration
- Patient with any gastrointestinal surgery that could impact upon the absorption of study drug
- Patient who donated blood to a blood bank or in a clinical study (except a screening visit) within 12 weeks of study drug administration (within 2 weeks for plasma only)
- Patient who received a blood transfusion within 12 weeks of study drug administration
- Other protocol defined inclusion/exclusion criteria apply
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Anaheim Clinical Trials
Anaheim, California, 92801
PRA Health Sciences
Salt Lake City, Utah, 84107
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986235 in Healthy Subjects
This is a study of experimental medication BMS-986235 in healthy subjects.
- Conditions
- Mediators of Inflammation
- Being tested
- BMS-986235, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986235Drug
Specified dose on specified days
PlaceboOther
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Single ascending dose (SAD): BMS-986235 or Placebo | Experimental | BMS-986235 or Placebo oral dose Receives: Drug: BMS-986235; Other: Placebo |
| Multiple ascending dose (MAD): BMS-986235 or Placebo | Experimental | BMS-986235 or Placebo oral dose Receives: Drug: BMS-986235; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of serious adverse events (SAE)
Measured: Approximately 30 days
Number of deaths
Measured: Approximately 30 days
Number of adverse events (AE) leading to study discontinuation
Measured: Approximately 30 days
Number of patients with clinically significant changes in ECG parameters, as defined by the investigator
Measured: Approximately 30 days
Number of patients with potentially clinically significant changes in vital signs
Measured: Approximately 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start15 Nov 2017
- Primary completion2 Jul 2021
- Study completion2 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mediators of InflammationStudies 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
- 122 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
- NCT03335553
- Sponsor's protocol ID
- CV018-001
- Status last verified
- Mar 2022
- First submitted
- 6 Nov 2017
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Singh J, Jackson KL, Fang H, Gumanti A, Claridge B, Tang FS, Kiriazis H, Salimova E, Parker AM, Nowell C, Woodman OL, Greening DW, Ritchie RH, Head GA, Qin CX. Novel formylpeptide receptor 1/2 agonist limits hypertension-induced cardiovascular damage. Cardiovasc Res. 2024 Sep 21;120(11):1336-1350. doi: 10.1093/cvr/cvae103.
PubMed 38879891
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986235 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03335553
- Acronym / sponsor ID
- CV018-001
- Conditions
- Mediators of Inflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 2 Jul 2021 (actual)
- First posted
- 7 Nov 2017 (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.
This is a study of experimental medication BMS-986235 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single ascending dose (SAD): BMS-986235 or Placebo | Experimental | Drug: BMS-986235, Other: PlaceboBMS-986235 or Placebo oral dose |
| Multiple ascending dose (MAD): BMS-986235 or Placebo | Experimental | Drug: BMS-986235, Other: PlaceboBMS-986235 or Placebo oral dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients must be normal healthy volunteers as determined by no clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations
- Patients must have a body mass index (BMI) of 18 - 30 mg/kg2, inclusive
Key exclusion criteria (8 listed)
- Patients that are pregnant
- Patient with any significant acute or chronic medical illness
- Patient with a current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
- Patient with any surgery within 12 weeks of study treatment administration
- Patient with any gastrointestinal surgery that could impact upon the absorption of study drug
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-986235Specified dose on specified days | Drug | Multiple ascending dose (MAD): BMS-986235 or Placebo, Single ascending dose (SAD): BMS-986235 or Placebo |
| PlaceboSpecified dose on specified days | Other | Multiple ascending dose (MAD): BMS-986235 or Placebo, Single ascending dose (SAD): BMS-986235 or Placebo |
Primary outcome
Number of serious adverse events (SAE)
Time frame: Approximately 30 days
Number of deaths
Time frame: Approximately 30 days
Number of adverse events (AE) leading to study discontinuation
Time frame: Approximately 30 days
Number of patients with clinically significant changes in ECG parameters, as defined by the investigator
Time frame: Approximately 30 days
Number of patients with potentially clinically significant changes in vital signs
Time frame: Approximately 30 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 31 Mar 2022.
- Derived from this study: PubMed 38879891Singh J, Jackson KL, Fang H, Gumanti A, Claridge B, Tang FS, Kiriazis H, Salimova E, Parker AM, Nowell C, Woodman OL, Greening DW, Ritchie RH, Head GA, Qin CX. Novel formylpeptide receptor 1/2 agonist limits hypertension-induced cardiovascular damage. Cardiovasc Res. 2024 Sep 21;120(11):1336-1350. doi: 10.1093/cvr/cvae103.
- 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
2 sites 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-986235 in people with Mediators of Inflammation, run by Bristol-Myers Squibb at 2 sites 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 2 inclusion and 8 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 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Number of serious adverse events (SAE) (time frame: Approximately 30 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03335553, which also lists 1 linked publication.
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 Mar 2022.