A Study to Evaluate the Drug Levels of Mezigdomide in Adult Participants With Renal Impairment

NCT06318676 | Completed Phase 1 FDA Drug

• 1 other identifier: CA057-1009
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Renal Impairment

Keywords

Chronic Kidney Disease; End Stage Renal Disease; Dialysis; Hemodialysis; Mezigdomide; Pharmacokinetics; Healthy

Outcome Measures

Primary Outcomes (3)

• Maximum observed concentration (Cmax)

  Up to 24 days

• Area under the plasma concentration-time curve (AUC)

  Up to 24 days

• Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T))

  Up to 24 days

Secondary Outcomes (8)

• Number of participants with adverse events (AEs)

  Up to 54 days

• Number of participants with serious adverse events (SAEs)

  Up to 54 days

• Number of participants with physical examination findings

  Up to 24 days

• Number of participants with vital sign abnormalities

  Up to 24 days

• Number of participants with 12-lead electrocardiogram (ECG) findings

  Up to 24 days

Study Arms (3)

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

Interventions

Mezigdomide DRUG

Specified dose on specified days

Also known as: BMS-986348, CC-92480

Group A: Participants with severe renal impairment; Group B: Participants with End Stage Renal Disease; Group C: Participants with normal renal function

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (3)

PANAX

Miami Lakes, Florida, 33014, United States

Location

Omega Research Group - Orlando

Orlando, Florida, 32806, United States

Location

Orlando Clinical Research Center OCRC

Orlando, Florida, 32809, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start: March 21, 2024
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

US (3)