Hepatic ImpairmentPhase 1NCT05707390
A Study of Mezigdomide in Healthy Participants and Participants With Hepatic Impairment
A Phase 1 study testing Mezigdomide in people with Hepatic Impairment, run by Bristol-Myers Squibb at 3 sites in United States.
Trial summary
The aim of this study is to measure the concentration levels of mezigdomide in the blood of participants with mild, moderate, and severe hepatic impairment, and in matched healthy control participants with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- Mezigdomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Feb 2023to 13 Sep 2023
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hepatic Impaired Participants:
- Participants have mild, moderate, or severe hepatic impairment or cirrhosis due to chronic hepatic disease and/or prior alcohol use.
- Participants have mild (Group A), moderate (Group B), or severe (Group C) hepatic impairment as defined by Child-Pugh Score.
- Matched Healthy Participants:
- Participant must be free of any clinically significant disease that would interfere with the study evaluations.
- Participant must have liver-related laboratory test results within the respective reference ranges or with clinically insignificant excursions therefrom as agreed by the investigator.
Who cannot join
- All Participants:
- History of chronic pruritus or dermatologic syndromes that may be confounded with reactions to mezigdomide.
- Contraindication or intolerance to first-generation antihistamine medications.
- Hepatic Impaired Participants:
- -Clinical laboratory test results:
- Platelet count lower than 30,000/microliter (μL) at screening or Day -1.
Show all 10Show fewer
- Absolute neutrophil counts lower than 1,500/μL at screening or Day -1.
- Matched Healthy Participants:
- -History of or suspected benign ethnic neutropenia.
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
3 sites in 1 country.
United States3 sites
PANAX
Miami Lakes, Florida, 33014
Orlando Clinical Research Center OCRC
Orlando, Florida, 32809
The Texas Liver Institute
San Antonio, Texas, 78215
About this study
Official title: A Phase 1, Multicenter, Open-label, Single-dose Study to Assess the Pharmacokinetics of Mezigdomide in Healthy Participants and Those With Mild, Moderate, and Severe Hepatic Impairment
The aim of this study is to measure the concentration levels of mezigdomide in the blood of participants with mild, moderate, and severe hepatic impairment, and in matched healthy control participants with normal hepatic function.
- Conditions
- Hepatic Impairment
- Being tested
- Mezigdomide
- Keywords
- Mezigdomide, BMS-986348, CC-92480
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 |
|---|---|---|
| Mild hepatic impairment | Experimental | Not described Receives: Drug: Mezigdomide |
| Moderate hepatic impairment | Experimental | Not described Receives: Drug: Mezigdomide |
| Severe hepatic impairment | Experimental | Not described Receives: Drug: Mezigdomide |
| Healthy participants | 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 6 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-T])
Measured: Up to 6 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Measured: Up to 6 days
Secondary outcomes (8)
Number of participants with adverse events (AEs)
Measured: Up to 6 days
Number of participants with serious adverse events (SAEs)
Measured: Up to 6 days
Number of participants with physical examination abnormalities
Measured: Up to 6 days
Number of participants with vital sign abnormalities
Measured: Up to 6 days
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to 6 days
Number of participants with clinical laboratory abnormalities
Measured: Up to 6 days
Metabolic ratio of AUC(0-T)
Measured: Up to 6 days
Metabolic ratio of AUC(0-INF)
Measured: Up to 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start20 Feb 2023
- Primary completion13 Sep 2023
- Study completion13 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- 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
- NCT05707390
- Sponsor's protocol ID
- CA057-1010
- Status last verified
- Feb 2024
- First submitted
- 23 Jan 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-label, Single-dose Study to Assess the Pharmacokinetics of Mezigdomide in Healthy Participants and Those With Mild, Moderate, and Severe Hepatic Impairment
- ClinicalTrials.gov ID
- NCT05707390
- Acronym / sponsor ID
- CA057-1010
- Conditions
- Hepatic Impairment
- Keywords
- Mezigdomide, BMS-986348, CC-92480
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 31 Jan 2023 (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 aim of this study is to measure the concentration levels of mezigdomide in the blood of participants with mild, moderate, and severe hepatic impairment, and in matched healthy control participants with normal hepatic function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mild hepatic impairment | Experimental | Drug: Mezigdomide |
| Moderate hepatic impairment | Experimental | Drug: Mezigdomide |
| Severe hepatic impairment | Experimental | Drug: Mezigdomide |
| Healthy participants | Experimental | Drug: Mezigdomide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants have mild, moderate, or severe hepatic impairment or cirrhosis due to chronic hepatic disease and/or prior alcohol use.
- Participants have mild (Group A), moderate (Group B), or severe (Group C) hepatic impairment as defined by Child-Pugh Score.
- Participant must be free of any clinically significant disease that would interfere with the study evaluations.
- Participant must have liver-related laboratory test results within the respective reference ranges or with clinically insignificant excursions therefrom as agreed by the investigator.
Key exclusion criteria (10 listed)
- History of chronic pruritus or dermatologic syndromes that may be confounded with reactions to mezigdomide.
- Contraindication or intolerance to first-generation antihistamine medications.
- Platelet count lower than 30,000/microliter (μL) at screening or Day -1.
- Absolute neutrophil counts lower than 1,500/μL at screening or Day -1.
- -History of or suspected benign ethnic neutropenia.
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 | Healthy participants, Mild hepatic impairment, Moderate hepatic impairment, Severe hepatic impairment |
Primary outcome
Maximum observed concentration (Cmax)
Time frame: Up to 6 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-T])
Time frame: Up to 6 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Time frame: Up to 6 days
8 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to 6 days
Number of participants with serious adverse events (SAEs)
Time frame: Up to 6 days
Number of participants with physical examination abnormalities
Time frame: Up to 6 days
Number of participants with vital sign abnormalities
Time frame: Up to 6 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 6 days
Number of participants with clinical laboratory abnormalities
Time frame: Up to 6 days
Metabolic ratio of AUC(0-T)
Time frame: Up to 6 days
Metabolic ratio of AUC(0-INF)
Time frame: Up to 6 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 7 Feb 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: No. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.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 Hepatic Impairment, run by Bristol-Myers Squibb 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 6 inclusion and 10 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 7 Feb 2024. 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 6 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 7 Feb 2024.