Recruiting at 3 sites Phase 1 Kidney Failure, Chronic

Kidney Failure, Chronic study: Golcadomide

Official title A Study to Evaluate the Pharmacokinetics and Safety of Golcadomide in Participants With Severe Renal Impairment and End-Stage Renal Disease Compared With Participants With Normal Renal Function

ClinicalTrials.gov ID: NCT07763418

What this study is testing

What is Golcadomide?

This is an investigational medicine being studied to see how it moves through the body in people with kidney failure. is designed to block a protein called cereblon, which helps control the growth of certain blood cells.

Also referred to as BMS-986369, CC-99282.

Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This study aims to see how the body handles the drug golcadomide and check for any safety issues in people with different levels of kidney function.
Who it's for
The study is looking for healthy adults and adults with severe kidney failure or end-stage renal disease.
What's involved
Participants will take the study drug and undergo blood tests to measure how the drug moves through their body.
Time commitment
The source text does not specify the total duration or the number of visits required.
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 84. Healthy volunteers may be eligible.

You may be able to join if

  • Participant must have severe renal impairment (RI).
  • Participant must have end-stage renal disease (ESRD).
  • Participant must be healthy male and female participants not of childbearing potential between 18 and 84 years of age (inclusive) with a BMI between...

You likely can't join if

  • Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism, and excretion (ADME).
  • Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study
  • Known or suspected active autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that...
  • Other protocol-defined inclusion/exclusion criteria apply.

The study team makes the final eligibility decision.

Where it is enrolling

  • Chandler, Arizona, United States
  • Miami Lakes, Florida, United States
  • Orlando, Florida, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 84 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Chandler, Arizona, United States; Miami Lakes, Florida, United States; Orlando, Florida, United States. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.