A Study to Evaluate the Drug Levels of Mezigdomide in Adult Participants With Renal Impairment
A Phase 1, Multi-center, Open-label, Single-dose Study to Assess the Pharmacokinetics of Mezigdomide (BMS-986348, CC-92480) in Adult Participants With Normal Renal Function, Severe Renal Impairment, and End-stage Renal Disease
Sponsor: Celgene
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
Request endpoint coverageKey Facts
Primary Endpoints (CT.gov)
Maximum observed concentration (Cmax)
Time frame: Up to 24 days
Area under the plasma concentration-time curve (AUC)
Time frame: Up to 24 days
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to 24 days
Secondary Endpoints
Number of participants with adverse events (AEs)
Number of participants with serious adverse events (SAEs)
Number of participants with physical examination findings
Eligibility Criteria
Inclusion Criteria * Participants must have a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 40.0 kg/m2 inclusive at screening. * Participants must have a body weight ≥ 50 kg at screening. * Participants must be afebrile (febrile is defined as ≥ 38°C or 100.4°F) at screening, check in, and predose. Exclusion Criteria * Participants must not have any history of chronic pruritus or dermatologic syndromes that may be confounded with reactions to mezigdomide. * Participants must not have any history of malignancy of any type other than in situ cervical cancer or surgically excised non-melanomatous skin cancers. * Participants with an inability to tolerate oral medication. * Other protocol-defined Inclusion/Exclusion criteria apply.
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
Request coverage →