Renal ImpairmentPhase 1NCT06318676
A Study to Evaluate the Drug Levels of Mezigdomide in Adult Participants With Renal Impairment
A Phase 1 study testing Mezigdomide in people with Renal Impairment, run by Celgene at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the drug levels of mezigdomide in participants with renal impairment. Read more about this study
- Who is it for?
- Ages 18 to 82 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- Mezigdomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Mar 2024to 15 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 82 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
PANAX
Miami Lakes, Florida, 33014
Omega Research Group - Orlando
Orlando, Florida, 32806
Orlando Clinical Research Center OCRC
Orlando, Florida, 32809
About this study
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
The purpose of this study is to evaluate the drug levels of mezigdomide in participants with renal impairment.
- Conditions
- Renal Impairment
- Being tested
- Mezigdomide
- Keywords
- Chronic Kidney Disease, End Stage Renal Disease, Dialysis, Hemodialysis, Mezigdomide, Pharmacokinetics, Healthy
- Medical subject headings
- Renal Insufficiency, Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MezigdomideDrug
Also called BMS-986348, CC-92480
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Group A: Participants with severe renal impairment | Experimental | Not described Receives: Drug: Mezigdomide |
| Group B: Participants with End Stage Renal Disease | Experimental | Not described Receives: Drug: Mezigdomide |
| Group C: Participants with normal renal function | Experimental | Not described Receives: Drug: Mezigdomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax)
Measured: Up to 24 days
Area under the plasma concentration-time curve (AUC)
Measured: Up to 24 days
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T))
Measured: Up to 24 days
Secondary outcomes (8)
Number of participants with adverse events (AEs)
Measured: Up to 54 days
Number of participants with serious adverse events (SAEs)
Measured: Up to 54 days
Number of participants with physical examination findings
Measured: Up to 24 days
Number of participants with vital sign abnormalities
Measured: Up to 24 days
Number of participants with 12-lead electrocardiogram (ECG) findings
Measured: Up to 24 days
Maximum observed concentration (Cmax)
Measured: Up to 24 days
Time of maximum observed concentration (Tmax)
Measured: Up to 24 days
Area under the plasma concentration-time curve (AUC)
Measured: Up to 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start21 Mar 2024
- Primary completion15 Nov 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318676
- Sponsor's protocol ID
- CA057-1009
- Status last verified
- May 2025
- First submitted
- 12 Mar 2024
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06318676
- Acronym / sponsor ID
- CA057-1009
- Conditions
- Renal Impairment
- Keywords
- Chronic Kidney Disease, End Stage Renal Disease, Dialysis, Hemodialysis, Mezigdomide, Pharmacokinetics, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the drug levels of mezigdomide in participants with renal impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Participants with severe renal impairment | Experimental | Drug: Mezigdomide |
| Group B: Participants with End Stage Renal Disease | Experimental | Drug: Mezigdomide |
| Group C: Participants with normal renal function | Experimental | Drug: Mezigdomide |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MezigdomideAlso: BMS-986348, CC-92480Specified dose on specified days | Drug | Group A: Participants with severe renal impairment, Group B: Participants with End Stage Renal Disease, Group C: Participants with normal renal function |
Primary outcome
Maximum observed concentration (Cmax)
Time frame: Up to 24 days
Area under the plasma concentration-time curve (AUC)
Time frame: Up to 24 days
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to 24 days
8 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to 54 days
Number of participants with serious adverse events (SAEs)
Time frame: Up to 54 days
Number of participants with physical examination findings
Time frame: Up to 24 days
Number of participants with vital sign abnormalities
Time frame: Up to 24 days
Number of participants with 12-lead electrocardiogram (ECG) findings
Time frame: Up to 24 days
Maximum observed concentration (Cmax)
Time frame: Up to 24 days
Time of maximum observed concentration (Tmax)
Time frame: Up to 24 days
Area under the plasma concentration-time curve (AUC)
Time frame: Up to 24 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mezigdomide in people with Renal Impairment, run by Celgene at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed concentration (Cmax) (time frame: Up to 24 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.