Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1 Open-label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Obeldesivir in Participants With Normal Renal Function and Renal Impairment

This research is testing a new medicine called Obeldesivir (also known as GS-5245) for people who have problems with their kidneys. The main goal is to understand how the body processes this medicine – how much ends up in your blood and how long it stays there. We also want to check for any side effects and make sure it's safe. This is a very early stage study, meaning it's one of the first times this medicine is given to people. It will help us decide if it's safe to continue testing this medicine in future, larger studies. We'll be giving different doses to see the effects.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Gilead Sciences Inc.

Enrolment target

Start

15 Jan 2024

Renal Impairment

What is this study about?

This study is about a new medicine called Obeldesivir, which is currently in its very early testing stages. Our main aim is to understand how your body handles this medicine, especially if you have kidney problems. Kidneys play a big role in cleaning the blood and removing medicines from your system, so it's important to see if having kidney issues changes how Obeldesivir works.

We'll be looking closely at how much of the medicine gets into your blood, how quickly it gets there, and how long it stays around. This helps us work out the best dose for people. We're also carefully checking for any side effects to make sure the medicine is safe to use. This kind of study, called a Phase 1 study, is really important because it gives us fundamental information before we can test the medicine in larger groups of people.

The information we gather from this study will help doctors and scientists decide if Obeldesivir has the potential to be a useful treatment in the future. It’s a foundational step in the long process of developing new medicines.

Key takeaways

It's a very early-stage study for a new medicine called Obeldesivir.
The main goal is to understand how the body handles the medicine, especially with kidney problems.
Safety is a top priority, and you'll be closely monitored for side effects.
Participants will receive a single dose of the medicine.
Both people with healthy kidneys and those with kidney impairment can take part.
Your participation helps advance medical science for future treatments.

Who may be eligible?

This study is looking for adults aged 18 and over. Both men and women can take part.

Participants will be divided into different groups: some with completely healthy kidneys, and others with varying degrees of kidney problems. We need to compare how the medicine works in both groups.

Specific medical checks will be done to confirm if you have healthy kidney function or if you have kidney impairment that fits the study's requirements. You won't be able to join if you have certain other serious health conditions.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you able to attend several clinic visits for tests?
Do you have a diagnosis of kidney impairment (or completely healthy kidneys for comparison)?
Are you willing to take a single dose of a new study medicine?
Are you comfortable with regular blood and urine tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given a single dose of the study medicine, either 175 mg or 350 mg of GS-5245 tablets. You will need to attend several visits at the study clinic. During these visits, blood and urine samples will be taken frequently to measure how much of the medicine is in your system and how your body is reacting. We will also check your general health, blood pressure, and look for any side effects. The total duration of your involvement in the study will be explained in detail by the study team, but it will involve multiple visits over a specific period after you take the medicine.

Potential risks and benefits

Taking part in this study may not directly benefit you, but the information we learn could help others in the future by contributing to the development of new treatments. As with any new medicine, there's always a chance of side effects, which could range from mild to more serious. The research team will monitor you very closely for any reactions. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is Obeldesivir?

Obeldesivir is a new medicine being tested to see how it works in the body and if it's safe, especially for people with kidney issues.

Why is this study important?

This study helps us understand how the body processes the medicine and checks for safety, which is a key first step before it can be developed further.

Will I get better if I join this study?

This study is designed to gather information, not to treat your condition. There's no guarantee you will personally benefit, but your help contributes to future medical knowledge.

What kind of kidney problems are you looking for?

We are looking for people with different levels of kidney problems, from mild to more severe, as well as people with healthy kidneys for comparison.

How long will I be involved in the study?

The study team will explain the exact duration of your participation, including the number of visits and how long they will take.