Evaluating Mezigdomide Drug Levels in Adults with Kidney Issues
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
PHASE1 · Celgene · NCT06318676
This study is testing how well the drug mezigdomide is processed in adults with kidney problems to help determine the right dosage and safety for them.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 82 Years |
| Sex | All |
| Sponsor | Celgene (industry) |
| Locations | 3 sites (Miami Lakes, Florida and 2 other locations) |
| Trial ID | NCT06318676 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the levels of the drug mezigdomide in adult participants who have renal impairment. It involves administering the drug to individuals with varying degrees of kidney function to understand how their bodies process it. The study will include participants with chronic kidney disease and those on dialysis, focusing on their drug absorption and metabolism. The findings could provide insights into the appropriate dosing and safety of mezigdomide for this population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with renal impairment who meet specific BMI and weight criteria.
Not a fit: Patients with a history of chronic pruritus, certain malignancies, or those unable to tolerate oral medication may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective dosing guidelines for mezigdomide in patients with renal impairment.
How similar studies have performed: While this study focuses on a specific drug and population, similar studies evaluating drug levels in patients with renal impairment have shown promising results in optimizing treatment.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Miami Lakes, Florida and 2 other locations
- PANAX — Miami Lakes, Florida, United States (RECRUITING)
- Omega Research Group - Orlando — Orlando, Florida, United States (RECRUITING)
- Orlando Clinical Research Center OCRC — Orlando, Florida, United States (RECRUITING)
Study contacts
- Study coordinator: BMS Study Connect www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Renal Impairment, Chronic Kidney Disease, End Stage Renal Disease, Dialysis, Hemodialysis, Mezigdomide, Pharmacokinetics, Healthy