NCT06318676CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 4 Jun 2025
Brief summary (registry, in English)
The purpose of this study is to evaluate the drug levels of mezigdomide in participants with renal impairment.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- First submitted
- 12 Mar 2024
- Start date
- 21 Mar 2024
- Primary completion date
- 15 Nov 2024
- Lead sponsor
- Celgene
- Diseases
- Chronic kidney disease
- NCT number
- NCT06318676
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 26
- From 21 Mar 2024 to the primary completion date, 15 Nov 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants with an inability to tolerate oral medication.
Other illness
- 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.
Other
- Other protocol-defined Inclusion/Exclusion criteria apply.
Who the study is looking for
- 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.
Age in the registry: 18 years to 82 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| PANAX Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Orlando Clinical Research Center (OCRC) Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Omega Research Group - Orlando Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.