GSK4771261 for Polycystic Kidney Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, GSK4771261, for safety and effectiveness in people with polycystic kidney disease, a condition characterized by cysts forming in the kidneys. In the first part, researchers administer the treatment to healthy participants to assess its safety and effects. In the second part, the drug is tested on individuals with autosomal dominant polycystic kidney disease (ADPKD) to evaluate its interaction with their condition. Individuals with a confirmed diagnosis of ADPKD and related complications may be suitable candidates for the trial. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Will I have to stop taking my current medications?
Yes, participants must stop taking prescription and non-prescription drugs, including vitamins and supplements, at least 7 days or 5 half-lives before the first dose of the study drug and throughout the study. However, paracetamol is allowed at doses up to 4 grams per day.
Is there any evidence suggesting that GSK4771261 is likely to be safe for humans?
Research shows that GSK4771261 is undergoing testing to determine its safety for humans. This Phase 1 trial marks the first time GSK4771261 is being administered to people, beginning with healthy volunteers. The focus of this phase is to assess safety, evaluate how well individuals tolerate the treatment, and identify any side effects.
Specific side effects or reactions for GSK4771261 remain limited due to the early stage of testing. However, Phase 1 trials aim to establish the safest doses and monitor for any side effects. This process helps researchers determine if the treatment can be safely used in individuals with polycystic kidney disease. If GSK4771261 performs well in this stage, it will advance to further testing with a larger group of participants.12345Why do researchers think this study treatment might be promising for kidney disease?
GSK4771261 is unique because it targets polycystic kidney disease through a potentially new mechanism compared to traditional treatments like tolvaptan, which primarily focuses on slowing cyst growth. Researchers are excited about GSK4771261 because it may offer a more targeted approach, potentially improving kidney function and slowing disease progression more effectively. Additionally, the drug is being tested across various doses, which could help in fine-tuning the treatment for optimal efficacy and safety. This focus on personalized dosing could provide better outcomes for patients with autosomal dominant polycystic kidney disease (ADPKD).
What evidence suggests that GSK4771261 might be an effective treatment for polycystic kidney disease?
Research suggests that the drug GSK4771261 might help treat autosomal dominant polycystic kidney disease (ADPKD). This trial will evaluate different dose levels of GSK4771261, with some participants receiving the drug and others a placebo. Early studies have examined its safety and behavior in the body, showing promising results in controlling cyst growth. While detailed information on its effectiveness in humans with ADPKD is still being gathered, its mechanism suggests it could help slow the disease.12367
Who Is on the Research Team?
GSK Clinical Trials
Principal Investigator
GlaxoSmithKline
Are You a Good Fit for This Trial?
This trial is for healthy individuals and those with autosomal dominant polycystic kidney disease (ADPKD). Participants must weigh at least 45 kg, have a BMI of 19.5-32, and be able to consent. Women should not be able to bear children. People with ADPKD can join if they're generally healthy aside from their kidney condition.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive single ascending doses of GSK4771261 or placebo to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GSK4771261
Find a Clinic Near You
Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School