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Completed

NCT Number: NCT06318676

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

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

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Key information

Conditions

Renal Impairment Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–82 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PANAX, Miami Lakes, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mezigdomide

Drug

Specified dose on specified days

Other names: BMS-986348, CC-92480

Primary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Up to 24 days

  2. Area under the plasma concentration-time curve (AUC)

    Time frame: Up to 24 days

  3. 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

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 54 days

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to 54 days

  3. Number of participants with physical examination findings

    Time frame: Up to 24 days

  4. Number of participants with vital sign abnormalities

    Time frame: Up to 24 days

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

    Time frame: Up to 24 days

  6. Maximum observed concentration (Cmax)

    Time frame: Up to 24 days

  7. Time of maximum observed concentration (Tmax)

    Time frame: Up to 24 days

  8. Area under the plasma concentration-time curve (AUC)

    Time frame: Up to 24 days

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 19, 2024
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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