Healthy VolunteersPhase 1NCT05389722
A Study to Assess the Drug Levels of CC-92480 After Coadministration With Rifampin and Itraconazole, and the Drug Levels of Digoxin and Rosuvastatin After Coadministration With CC-92480 in Healthy Participants
A Phase 1 study testing CC-92480, Rifampin and Itraconazole in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the drug levels of CC-92480 after coadministration with rifampin and itraconazole and the drug levels of digoxin and rosuvastatin after coadministration with CC-92480 in 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 Volunteers
- What is being tested?
- CC-92480, Rifampin and Itraconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2022to 12 Nov 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
- Must have a body mass index between 18 and 33 kg/m2 (inclusive)
- Adult female of nonchildbearing potential or male, any race or ethnicity, and in good health as determined by the medical history, physical exam, vital signs, 12-lead electrocardiogram, and clinical laboratory assessments
Who cannot join
- Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism, and excretion
- Any major surgery within 4 weeks of the first dose administration
- History of drug abuse within 2 years of the first dose administration
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit - Dallas
Dallas, Texas, 75247-4968
About this study
Official title: A Phase 1, Parallel-group, 3-part, 2-period, Fixed-sequence, Crossover, Open-label, Nonrandomized, Drug-drug Interaction Study to Assess the Pharmacokinetics of CC-92480 (BMS-986348) After Coadministration With Rifampin and Itraconazole, and Pharmacokinetics of Digoxin and Rosuvastatin After Coadministration With CC-92480 in Healthy Participants
The purpose of this study is to evaluate the drug levels of CC-92480 after coadministration with rifampin and itraconazole and the drug levels of digoxin and rosuvastatin after coadministration with CC-92480 in healthy participants.
- Conditions
- Healthy Volunteers
- Being tested
- CC-92480, Rifampin, Itraconazole, Digoxin, Rosuvastatin
- Keywords
- CC-92480, Healthy Volunteer, Pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-92480Drug
Also called BMS-986348
Specified dose on specified days
RifampinDrug
Specified dose on specified days
ItraconazoleDrug
Specified dose on specified days
DigoxinDrug
Specified dose on specified days
RosuvastatinDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Not described Receives: Drug: CC-92480; Drug: Rifampin |
| Part 2 | Experimental | Not described Receives: Drug: CC-92480; Drug: Itraconazole |
| Part 3 | Experimental | Not described Receives: Drug: CC-92480; Drug: Digoxin; Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: Up to 2 months
Time of maximum observed plasma concentration (Tmax)
Measured: Up to 2 months
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Measured: Up to 2 months
Secondary outcomes (5)
Number of participants with adverse events (AEs)
Measured: Up to 3 months
Number of participants with physical examination findings
Measured: Up to 3 months
Number of participants with vital sign abnormalities
Measured: Up to 3 months
Number of participants with 12-lead electrocardiogram (ECG) abnormalities
Measured: Up to 3 months
Number of participants with clinical laboratory abnormalities
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start9 Jun 2022
- Primary completion12 Nov 2022
- Study completion12 Nov 2022
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 Healthy VolunteersStudies 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
- 24 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
- NCT05389722
- Sponsor's protocol ID
- CA057-002
- Status last verified
- Apr 2023
- First submitted
- 20 May 2022
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Burnett J, Sychterz C, Katz J, Shakeel F, Silva J, Chen W, Shahane A, Wang X, Lamba M, Gaudy A. Application of Physiologically Based Pharmacokinetic Modeling to Inform Dose Selection of Mezigdomide in a Phase I Drug-Drug Interaction Study. Clin Pharmacol Ther. 2026 Mar;119(3):641-650. doi: 10.1002/cpt.70082. Epub 2025 Oct 7.
PubMed 41058119
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Parallel-group, 3-part, 2-period, Fixed-sequence, Crossover, Open-label, Nonrandomized, Drug-drug Interaction Study to Assess the Pharmacokinetics of CC-92480 (BMS-986348) After Coadministration With Rifampin and Itraconazole, and Pharmacokinetics of Digoxin and Rosuvastatin After Coadministration With CC-92480 in Healthy Participants
- ClinicalTrials.gov ID
- NCT05389722
- Acronym / sponsor ID
- CA057-002
- Conditions
- Healthy Volunteers
- Keywords
- CC-92480, Healthy Volunteer, Pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 12 Nov 2022 (actual)
- Study completion
- 12 Nov 2022 (actual)
- First posted
- 25 May 2022 (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 evaluate the drug levels of CC-92480 after coadministration with rifampin and itraconazole and the drug levels of digoxin and rosuvastatin after coadministration with CC-92480 in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: CC-92480, Drug: Rifampin |
| Part 2 | Experimental | Drug: CC-92480, Drug: Itraconazole |
| Part 3 | Experimental | Drug: CC-92480, Drug: Digoxin, Drug: Rosuvastatin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Must have a body mass index between 18 and 33 kg/m2 (inclusive)
- Adult female of nonchildbearing potential or male, any race or ethnicity, and in good health as determined by the medical history, physical exam, vital signs, 12-lead electrocardiogram, and clinical laboratory assessments
Key exclusion criteria (4 listed)
- Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism, and excretion
- Any major surgery within 4 weeks of the first dose administration
- History of drug abuse within 2 years of the first dose administration
- 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 |
|---|---|---|
| CC-92480Also: BMS-986348Specified dose on specified days | Drug | Part 1, Part 2, Part 3 |
| RifampinSpecified dose on specified days | Drug | Part 1 |
| ItraconazoleSpecified dose on specified days | Drug | Part 2 |
| DigoxinSpecified dose on specified days | Drug | Part 3 |
| RosuvastatinSpecified dose on specified days | Drug | Part 3 |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to 2 months
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 2 months
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Time frame: Up to 2 months
5 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to 3 months
Number of participants with physical examination findings
Time frame: Up to 3 months
Number of participants with vital sign abnormalities
Time frame: Up to 3 months
Number of participants with 12-lead electrocardiogram (ECG) abnormalities
Time frame: Up to 3 months
Number of participants with clinical laboratory abnormalities
Time frame: Up to 3 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 19 Apr 2023.
- Derived from this study: PubMed 41058119Burnett J, Sychterz C, Katz J, Shakeel F, Silva J, Chen W, Shahane A, Wang X, Lamba M, Gaudy A. Application of Physiologically Based Pharmacokinetic Modeling to Inform Dose Selection of Mezigdomide in a Phase I Drug-Drug Interaction Study. Clin Pharmacol Ther. 2026 Mar;119(3):641-650. doi: 10.1002/cpt.70082. Epub 2025 Oct 7.
- 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 CC-92480, Rifampin and Itraconazole in people with Healthy Volunteers, 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 2 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 19 Apr 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?
Maximum observed plasma concentration (Cmax) (time frame: Up to 2 months). The study lists 3 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 NCT05389722, 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 19 Apr 2023.