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, 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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05389722

Enrollment

24

Registered

2022-05-25

Start date

2022-06-09

Completion date

2022-11-12

Last updated

2023-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

CC-92480, Healthy Volunteer, Pharmacokinetic

Brief 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.

Interventions

Specified dose on specified days

DRUGRifampin

Specified dose on specified days

DRUGItraconazole

Specified dose on specified days

DRUGDigoxin

Specified dose on specified days

DRUGRosuvastatin

Specified dose on specified days

Sponsors

Bristol-Myers Squibb

Lead SponsorINDUSTRY

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* 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/

Design outcomes

Primary

Measure	Time frame
Maximum observed plasma concentration (Cmax)	Up to 2 months
Time of maximum observed plasma concentration (Tmax)	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))	Up to 2 months

Secondary

Measure	Time frame
Number of participants with 12-lead electrocardiogram (ECG) abnormalities	Up to 3 months
Number of participants with adverse events (AEs)	Up to 3 months
Number of participants with clinical laboratory abnormalities	Up to 3 months
Number of participants with physical examination findings	Up to 3 months
Number of participants with vital sign abnormalities	Up to 3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026