A Study to Evaluate the Drug Levels of Mezigdomide in Adult Participants With Renal Impairment

Celgene

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: Mezigdomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06318676

CA057-1009

Details and patient eligibility

About

The purpose of this study is to evaluate the drug levels of mezigdomide in participants with renal impairment.

Enrollment: 26 patients

Sex: All

Ages: 18 to 82 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 3 patient groups

Group A: Participants with severe renal impairment

Experimental group

Treatment:

Drug: Mezigdomide

Group B: Participants with End Stage Renal Disease

Experimental group

Treatment:

Drug: Mezigdomide

Group C: Participants with normal renal function

Experimental group

Treatment:

Drug: Mezigdomide