Healthy ParticipantsPhase 1NCT04464577
A Study to Evaluate the Effect of Fluconazole, Bupropion, or Itraconazole on the Drug Levels and Safety of BMS-986235
A Phase 1 study testing Fluconazole, Bupropion and Itraconazole in people with Healthy Participants, run by Bristol-Myers Squibb at 2 sites in United States.
Trial summary
This study will evaluate the effect of inhibitors, at steady state, on the drug levels, safety, and tolerability of BMS-986235 when taken by healthy participants. The inhibitors to be utilized in this study are fluconazole, bupropion, and itraconazole. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Fluconazole, Bupropion and Itraconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2021to 8 Jun 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening.
- Males and females must agree to follow specific methods of contraception, if applicable.
- Healthy participants, as determined by no clinically significant deviation from normal in physical examination, ECGs, and clinical laboratory determinations, and no significant findings in medical history.
Who cannot join
- Women of childbearing potential (WOCBP), women who are pregnant or breastfeeding
- Inability to tolerate oral medication
- Known previous exposure to BMS-986235.
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Local Institution
Lenexa, Kansas, 66219
Local Institution
Salt Lake City, Utah, 84124
About this study
Official title: A Phase 1, Open-label Study to Evaluate the Effect of Fluconazole, Bupropion, or Itraconazole on the Pharmacokinetics and Safety of BMS-986235
This study will evaluate the effect of inhibitors, at steady state, on the drug levels, safety, and tolerability of BMS-986235 when taken by healthy participants. The inhibitors to be utilized in this study are fluconazole, bupropion, and itraconazole.
- Conditions
- Healthy Participants
- Being tested
- Fluconazole, Bupropion, Itraconazole, BMS-986235
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluconazoleDrug
Specified Dose on Specified Days
BupropionDrug
Specified Dose on Specified Days
ItraconazoleDrug
Specified Dose on Specified Days
BMS-986235Drug
Specified Dose on Specified Days
| Study group | Role | What they receive |
|---|---|---|
| Arm A: BMS-986235+Fluconazole | Experimental | Not described Receives: Drug: Fluconazole; Drug: BMS-986235 |
| Arm B: BMS-986235+ Bupropion | Experimental | Not described Receives: Drug: Bupropion; Drug: BMS-986235 |
| Arm C: BMS-986235+ Itraconazole | Experimental | Not described Receives: Drug: Itraconazole; Drug: BMS-986235 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with fluconazole
Measured: Day 12
Maximum plasma concentration (Cmax) of BMS-986235 with fluconazole
Measured: Day 12
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with fluconazole
Measured: Day 12
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with bupropion
Measured: Day 13
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with bupropion
Measured: Day 13
Maximum plasma concentration (Cmax) of BMS-986235 with bupropion
Measured: Day 13
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with itraconazole
Measured: Day 9
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with itraconazole
Measured: Day 9
Maximum plasma concentration (Cmax) of BMS-986235 with itraconazole
Measured: Day 9
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) 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
Maximum plasma concentration (Cmax) of BMS-986235
Measured: Day 1
Secondary outcomes (14)
Incidence of Nonserious Adverse Events (AEs)
Measured: Up to 49 days
Incidence of Serious Adverse Events (SAEs)
Measured: Up to 77 days
Incidence of AEs leading to discontinuation
Measured: Up to 16 days
Number of clinically significant changes from baseline in vital signs: Body Temperature
Measured: Up to 44 days
Number of clinically significant changes from baseline in physical examinations
Measured: Up to 44 days
Number of clinically significant changes in clinical laboratory tests: Hematology
Measured: Up to 44 days
Number of clinically significant changes in clinical laboratory tests: Clinical Chemistry
Measured: Up to 44 days
Number of clinically significant changes in clinical laboratory tests: Coagulation
Measured: Up to 44 days
Number of clinically significant changes in clinical laboratory tests: Urinalysis
Measured: Up to 44 days
Number of clinically significant changes from baseline in vital signs: Respiratory Rate
Measured: Up to 44 days
Number of clinically significant changes from baseline in vital signs: Heart Rate
Measured: Up to 44 days
Number of clinically significant changes from baseline in vital signs:Blood Pressure
Measured: Up to 44 days
Number of clinically significant changes in electrocardiogram (ECG)
Measured: Up to 44 days
Number of clinically significant changes in vital signs: Oxygen saturation (the amount of oxygen in blood (SpO2))
Measured: Up to 44 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start1 Apr 2021 (estimated)
- Primary completion7 Jun 2021 (estimated)
- Study completion8 Jun 2021 (estimated)
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
- Non-randomised
- Intervention model
- Parallel groups
- 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
- NCT04464577
- Sponsor's protocol ID
- CV018-014
- Status last verified
- Mar 2022
- First submitted
- 23 Mar 2020
- Last updated
- 25 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 25 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 Fluconazole, Bupropion, or Itraconazole on the Pharmacokinetics and Safety of BMS-986235
- ClinicalTrials.gov ID
- NCT04464577
- Acronym / sponsor ID
- CV018-014
- 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
- 1 Apr 2021 (estimated)
- Primary completion
- 7 Jun 2021 (estimated)
- Study completion
- 8 Jun 2021 (estimated)
- First posted
- 9 Jul 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.
This study will evaluate the effect of inhibitors, at steady state, on the drug levels, safety, and tolerability of BMS-986235 when taken by healthy participants. The inhibitors to be utilized in this study are fluconazole, bupropion, and itraconazole.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: BMS-986235+Fluconazole | Experimental | Drug: Fluconazole, Drug: BMS-986235 |
| Arm B: BMS-986235+ Bupropion | Experimental | Drug: Bupropion, Drug: BMS-986235 |
| Arm C: BMS-986235+ Itraconazole | Experimental | Drug: Itraconazole, Drug: BMS-986235 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening.
- Males and females must agree to follow specific methods of contraception, if applicable.
- Healthy participants, as determined by no clinically significant deviation from normal in physical examination, ECGs, and clinical laboratory determinations, and no significant findings in medical history.
Key exclusion criteria (4 listed)
- Women of childbearing potential (WOCBP), women who are pregnant or breastfeeding
- Inability to tolerate oral medication
- Known previous exposure to BMS-986235.
- 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 |
|---|---|---|
| FluconazoleSpecified Dose on Specified Days | Drug | Arm A: BMS-986235+Fluconazole |
| BupropionSpecified Dose on Specified Days | Drug | Arm B: BMS-986235+ Bupropion |
| ItraconazoleSpecified Dose on Specified Days | Drug | Arm C: BMS-986235+ Itraconazole |
| BMS-986235Specified Dose on Specified Days | Drug | Arm A: BMS-986235+Fluconazole, Arm B: BMS-986235+ Bupropion, Arm C: BMS-986235+ Itraconazole |
Primary outcome
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with fluconazole
Time frame: Day 12
Maximum plasma concentration (Cmax) of BMS-986235 with fluconazole
Time frame: Day 12
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with fluconazole
Time frame: Day 12
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with bupropion
Time frame: Day 13
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with bupropion
Time frame: Day 13
Maximum plasma concentration (Cmax) of BMS-986235 with bupropion
Time frame: Day 13
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with itraconazole
Time frame: Day 9
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with itraconazole
Time frame: Day 9
Maximum plasma concentration (Cmax) of BMS-986235 with itraconazole
Time frame: Day 9
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) 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
Maximum plasma concentration (Cmax) of BMS-986235
Time frame: Day 1
14 secondary outcomes
Incidence of Nonserious Adverse Events (AEs)
Time frame: Up to 49 days
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 77 days
Incidence of AEs leading to discontinuation
Time frame: Up to 16 days
Number of clinically significant changes from baseline in vital signs: Body Temperature
Time frame: Up to 44 days
Number of clinically significant changes from baseline in physical examinations
Time frame: Up to 44 days
Number of clinically significant changes in clinical laboratory tests: Hematology
Time frame: Up to 44 days
Number of clinically significant changes in clinical laboratory tests: Clinical Chemistry
Time frame: Up to 44 days
Number of clinically significant changes in clinical laboratory tests: Coagulation
Time frame: Up to 44 days
Number of clinically significant changes in clinical laboratory tests: Urinalysis
Time frame: Up to 44 days
Number of clinically significant changes from baseline in vital signs: Respiratory Rate
Time frame: Up to 44 days
Number of clinically significant changes from baseline in vital signs: Heart Rate
Time frame: Up to 44 days
Number of clinically significant changes from baseline in vital signs:Blood Pressure
Time frame: Up to 44 days
Number of clinically significant changes in electrocardiogram (ECG)
Time frame: Up to 44 days
Number of clinically significant changes in vital signs: Oxygen saturation (the amount of oxygen in blood (SpO2))
Time frame: Up to 44 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 25 Mar 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
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 Fluconazole, Bupropion and Itraconazole in people with Healthy Participants, 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 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 25 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 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?
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with fluconazole (time frame: Day 12). The study lists 12 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 25 Mar 2022.