GSK4771261 for Polycystic Kidney Disease

A Study to Evaluate the Safety, Tolerability, and Effects on Blood and Urine Markers of Single Ascending Dose of GSK4771261 in Healthy Participants and Participants With Autosomal Dominant Polycystic Kidney Disease

Active_not_recruiting Phase 1 Interventional Study
Kidney Disease
Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
25 – 65
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
86 (estimated)
Sponsor
GlaxoSmithKline · Industry
Who this trial is looking for

This trial is looking for healthy participants and those with a kidney condition called autosomal dominant polycystic kidney disease (ADPKD) to test a new drug. Participants will receive treatment and be monitored for safety and effects on their body.

Are You a Good Fit for This Trial?
Rules you out Type 1 diabetesType 2 diabetes

You may be able to join if

  • I weigh at least 45 kilograms.
  • I can provide signed consent.
  • I have been diagnosed with autosomal dominant polycystic kidney disease.
  • I am otherwise healthy based on medical evaluation.
  • I do not have a confirmed pregnancy.
  • I have negative pregnancy tests before the MRI scan.
  • My kidney function (eGFR) is at least 45 mL/min/1.73m².

You may not be able to join if

  • I have a history of severe medical conditions that affect drug metabolism.
  • I have had cancer at any time.
  • I have kidney problems with eGFR less than 90 mL/min/1.73m².
  • I have diabetes.
  • I currently take other medications that interact with the study drug.
  • I am pregnant or breastfeeding.
  • I had a bone fracture in the last 6 months.
  • I have a positive HIV test.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
This is a study where a new drug, called GSK4771261 is being tested. Neither the study doctors, study staff or participants will be aware of what treatment is being given. Part A is testing the new study treatment on healthy people. This is to see if it's safe, what it does to the body, and how the body's defense system responds to it. Part B is similar, but the study treatment will be given to pe…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: For Part A * Body weight greater than or equal to (\>=) 45 kilograms (kg) and basal metabolic index (BMI) within the range 19.5 to 32 kilograms per square meters (kg/m\^2), inclusive * Capable of giving signed informed consent, * Participants who are overtly healthy as determin…
Contacts

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