Healthy ParticipantsPhase 1NCT04301310
Study to Evaluate the Effect of Rifampin on the Drug Levels in Blood and Safety of BMS-986235 in Healthy Participants
A Phase 1 study testing BMS-986235 (Treatment A) and Rifampin (Treatment B) 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 examine the effect of rifampin on the drug levels in blood and safety of BMS-986235, when taken by healthy participants. 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-986235 (Treatment A) and Rifampin (Treatment B)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2020to 16 Mar 2020
- 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 physical examination, ECGs, and clinical laboratory determinations; no significant findings in medical history.
- Body mass index of 18.0 kg/m2 to 30.0 kg/m2, inclusive, at screening
- Males must agree to follow specific methods of contraception, if applicable
Who cannot join
- Women of childbearing potential (WOCBP)
- Known previous exposure to BMS-986235
- History of any significant drug allergy
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label Study to Evaluate the Effect of Rifampin on the Single Dose Pharmacokinetics, Safety, and Tolerability of BMS-986235 in Healthy Participants
The purpose of this study is to examine the effect of rifampin on the drug levels in blood and safety of BMS-986235, when taken by healthy participants.
- Conditions
- Healthy Participants
- Being tested
- BMS-986235 (Treatment A), Rifampin (Treatment B)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986235 (Treatment A)Drug
Specified dose on specified days
Rifampin (Treatment B)Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Not described Receives: Drug: BMS-986235 (Treatment A); Drug: Rifampin (Treatment B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of BMS-986235
Measured: Day 1
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235
Measured: Day 1
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235
Measured: Day 1
Cmax of BMS-986235 with rifampin
Measured: Day 10
AUC(0-T) of BMS-986235 with rifampin
Measured: Day 10
AUC(INF) of BMS-986235 with rifampin
Measured: Day 10
Secondary outcomes (12)
Incidence of Nonserious Adverse Events (AEs)
Measured: Up to 46 days
Incidence of Serious Adverse Events (SAEs)
Measured: Up to 74 days
Incidence of AEs leading to discontinuation
Measured: Up to 13 days
Incidence of clinically significant changes from baseline in physical examination findings
Measured: Up to 41 days
Incidence of clinically significant changes in vital signs: Body temperature
Measured: Up to 41 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Measured: Up to 41 days
Incidence of clinically significant changes in vital signs: Blood pressure
Measured: Up to 41 days
Incidence of clinically significant changes in vital signs: Heart rate
Measured: Up to 41 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters
Measured: Up to 41 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Measured: Up to 41 days
Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests
Measured: Up to 41 days
Incidence of clinically significant changes in vital signs: Oxygen saturation (the amount of oxygen in blood (SpO2))
Measured: Up to 41 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start9 Mar 2020
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Why it stopped: Business objectives have changed
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT04301310
- Sponsor's protocol ID
- CV018-023
- Status last verified
- Mar 2022
- First submitted
- 6 Mar 2020
- Last updated
- 31 Mar 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 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Evaluate the Effect of Rifampin on the Single Dose Pharmacokinetics, Safety, and Tolerability of BMS-986235 in Healthy Participants
- ClinicalTrials.gov ID
- NCT04301310
- Acronym / sponsor ID
- CV018-023
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business objectives have changed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 10 Mar 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 examine the effect of rifampin on the drug levels in blood and safety of BMS-986235, when taken by healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: BMS-986235 (Treatment A), Drug: Rifampin (Treatment B) |
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 physical examination, ECGs, and clinical laboratory determinations; no significant findings in medical history.
- Body mass index of 18.0 kg/m2 to 30.0 kg/m2, inclusive, at screening
- Males must agree to follow specific methods of contraception, if applicable
Key exclusion criteria (4 listed)
- Women of childbearing potential (WOCBP)
- Known previous exposure to BMS-986235
- History of any significant drug allergy
- 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-986235 (Treatment A)Specified dose on specified days | Drug | Treatment Group |
| Rifampin (Treatment B)Specified dose on specified days | Drug | Treatment Group |
Primary outcome
Maximum plasma concentration (Cmax) of BMS-986235
Time frame: Day 1
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235
Time frame: Day 1
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235
Time frame: Day 1
Cmax of BMS-986235 with rifampin
Time frame: Day 10
AUC(0-T) of BMS-986235 with rifampin
Time frame: Day 10
AUC(INF) of BMS-986235 with rifampin
Time frame: Day 10
12 secondary outcomes
Incidence of Nonserious Adverse Events (AEs)
Time frame: Up to 46 days
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 74 days
Incidence of AEs leading to discontinuation
Time frame: Up to 13 days
Incidence of clinically significant changes from baseline in physical examination findings
Time frame: Up to 41 days
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 41 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 41 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 41 days
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 41 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters
Time frame: Up to 41 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time frame: Up to 41 days
Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests
Time frame: Up to 41 days
Incidence of clinically significant changes in vital signs: Oxygen saturation (the amount of oxygen in blood (SpO2))
Time frame: Up to 41 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink 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-986235 (Treatment A) and Rifampin (Treatment B) 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: withdrawn, 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Maximum plasma concentration (Cmax) of BMS-986235 (time frame: Day 1). The study lists 6 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 Mar 2022.