Clinical trial NCT06318676: A Study to Evaluate the Drug Levels of Mezigdomide in Adult Participants With Renal Impairment
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Keywords: Chronic Kidney Disease
End Stage Renal Disease
Dialysis
Hemodialysis
Mezigdomide
Pharmacokinetics
Healthy
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2024-03-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: Up to 24 days
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: Up to 24 days
measure: Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T))
timeFrame: Up to 24 days
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 54 days
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 54 days
measure: Number of participants with physical examination findings
timeFrame: Up to 24 days
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 24 days
measure: Number of participants with 12-lead electrocardiogram (ECG) findings
timeFrame: Up to 24 days
measure: Maximum observed concentration (Cmax)
timeFrame: Up to 24 days
measure: Time of maximum observed concentration (Tmax)
timeFrame: Up to 24 days
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: Up to 24 days
Other outcomes:
Locations:
city: Miami Lakes
country: United States
facility: PANAX
state: Florida
city: Orlando
country: United States
facility: Omega Research Group - Orlando
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center OCRC
state: Florida
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: