Renal Impairment
Conditions
Keywords
Chronic Kidney Disease, End Stage Renal Disease, Dialysis, Hemodialysis, Mezigdomide, Pharmacokinetics, Healthy
Brief summary
The purpose of this study is to evaluate the drug levels of mezigdomide in participants with renal impairment.
Interventions
DRUGMezigdomide
Specified dose on specified days
Sponsors
Celgene
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 82 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed concentration (Cmax) | Up to 24 days |
| Area under the plasma concentration-time curve (AUC) | Up to 24 days |
| Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) | Up to 24 days |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with vital sign abnormalities | Up to 24 days |
| Number of participants with 12-lead electrocardiogram (ECG) findings | Up to 24 days |
| Number of participants with adverse events (AEs) | Up to 54 days |
| Time of maximum observed concentration (Tmax) | Up to 24 days |
| Area under the plasma concentration-time curve (AUC) | Up to 24 days |
| Maximum observed concentration (Cmax) | Up to 24 days |
| Number of participants with serious adverse events (SAEs) | Up to 54 days |
| Number of participants with physical examination findings | Up to 24 days |
Countries
United States
Outcome results
None listed