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Study on How Kidney Function Affects the Drug GS-5245 in Patients With Normal and Impaired Kidney Function

InvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying how the body processes a medication called Obeldesivir in people with different levels of kidney function. The study involves participants with normal kidney function as well as those with renal impairment, which means their kidneys are not working as well as they should. The medication being tested, Obeldesivir, is given in the form of film-coated tablets, and the study will look at how it behaves in the body after a single dose.

The purpose of the study is to understand how kidney function affects the way Obeldesivir is absorbed, distributed, and eliminated by the body. Participants will be divided into groups based on their kidney function, and each group will receive a single dose of the medication. The study will monitor how the medication moves through the body and how it is broken down and removed. This will help researchers learn more about the safety and effectiveness of Obeldesivir in people with different levels of kidney function.

Throughout the study, participants will be closely monitored for any side effects or changes in their health. The study aims to provide valuable information that could help improve treatment options for people with kidney issues in the future. Participants will be required to follow specific guidelines and attend regular check-ups to ensure their safety and the accuracy of the study results.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Admission and initial assessment
Upon joining the study, participants will undergo an initial assessment. This includes a review of medical history, a physical examination, and vital signs measurement. Laboratory evaluations and a 12-lead ECG (a test that records the electrical activity of the heart) will be conducted to ensure there are no significant abnormalities.
Participants must be aged 18 to 79 years and have a body mass index (BMI) between 18.0 and 38.0 kg/m². Participants must not have donated blood within 56 days or plasma within 7 days before the study entry.
Step 2
Medication administration
Participants will receive a single dose of the study medication, Obeldesivir, in the form of GS-5245 tablets. The tablets are available in two dosages: 175 mg and 350 mg. The medication is taken orally, meaning it is swallowed.
The purpose of this step is to evaluate how the medication is processed in the body, particularly in participants with different levels of kidney function.
Step 3
Monitoring and follow-up
After taking the medication, participants will be monitored for any side effects or changes in laboratory results. This includes checking the concentration of the medication in the blood and urine to understand how it is absorbed, distributed, and eliminated by the body.
Participants will be required to stay in the study facility for a specified period to ensure their safety and to collect necessary data. The study aims to observe the pharmacokinetics (how the drug moves through the body) and safety of the medication.
Step 4
Completion and exit
Once the monitoring period is complete, participants will undergo a final assessment. This includes a review of any side effects experienced and a final set of laboratory tests to ensure there are no lasting effects from the medication.
Participants will be advised on any necessary follow-up actions and will be reminded to refrain from donating blood for at least 30 days after receiving the study medication.

Who can join the trial?

16 criteria

Have the ability to understand and sign a written informed consent form before starting the study procedures.
Have a specific kidney function level, measured by a test called eGFRCKD-EPI, creatinine, which should be:
- Between 60 and less than 90 for mild kidney disease.
- Between 30 and less than 60 for moderate kidney disease.
- Between 15 and less than 30 for severe kidney disease.
- Have liver enzyme levels, called AST (aspartate aminotransferase) and ALT (alanine aminotransferase), that are no more than 2 times the upper limit of normal at screening and admission.
- For matched control participants, have an eGFRCKD-EPI, creatinine of 90 or more at screening.
- Matched control participants must match in gender, age (within 10 years), and BMI (Body Mass Index, within 20%) with the participant in the renal impairment group.
- Have ALT and AST levels at or below the normal limit at screening and admission.
- Be aged between 18 and 79 years, inclusive, at screening and admission.
- Have a BMI of at least 18.0 and no greater than 38.0 at screening.
- Participants who can have children and engage in heterosexual intercourse must agree to use specific methods of birth control as described in the study.
- Have not donated blood within 56 days or plasma within 7 days before entering the study and must not donate blood during the study and for at least 30 days after receiving the study drug.
- Have laboratory and heart test results at screening and admission that do not show any significant abnormalities, as assessed by the investigator.
- Be willing and able to follow all study requirements.
- Be in good health, except for kidney function issues in the mild, moderate, and severe renal impairment groups, based on medical history and physical examination.
- For participants with impaired kidney function, have the same kidney function classification for the 3 months before screening and no signs of worsening kidney function during the screening period.

Who cannot join the trial?

7 criteria

Participants with severe **kidney problems** cannot join. **Kidney problems** mean that the kidneys are not working as well as they should.
Participants who have had a **kidney transplant** cannot join. A **kidney transplant** is when a person receives a new kidney from another person.
Participants who are currently on **dialysis** cannot join. **Dialysis** is a treatment that does some of the things done by healthy kidneys, like cleaning the blood.
Participants with any other serious health conditions that might affect the study cannot join. This means any other health problems that could make it hard to understand the results of the study.
Participants who are pregnant or breastfeeding cannot join. This is to ensure the safety of both the mother and the baby.
Participants who are taking certain medications that might interfere with the study cannot join. This means any medicine that could change how the study drug works.
Participants who have participated in another clinical trial recently cannot join. This is to make sure that the results of this study are not affected by other studies.

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Investigated drugs

Obeldesivir is a medication being studied to understand how it behaves in the body, particularly in people with different levels of kidney function. The trial aims to see how the body processes a single dose of this medication in people with normal kidney function compared to those with kidney problems. This helps researchers understand if the medication is safe and how it might need to be adjusted for people with kidney issues. The study is important for ensuring that the medication can be used safely by everyone, regardless of their kidney health.

Gs-5245

What is already known about the treatment

Obeldesivir – Obeldesivir is administered as a single dose in an open-label study to assess its behavior in the body and safety in people with different kidney functions. Currently, it is being studied in clinical trials and is not yet widely used in medical practice. The main focus of this study is to understand how the drug is processed in individuals with kidney problems compared to those with normal kidney function. Obeldesivir works at the molecular level by targeting specific viral components, although the exact mechanism is still under investigation. It is classified as an antiviral medication, aiming to treat infections by interfering with the virus's ability to multiply.

Investigated diseases

Renal Impairment – Renal impairment refers to a condition where the kidneys are not functioning at their full capacity. This can lead to a reduced ability to filter waste products from the blood, regulate fluid and electrolyte balance, and maintain proper blood pressure. The progression of renal impairment can vary, often starting with mild symptoms that may go unnoticed. As the condition advances, individuals may experience fatigue, swelling in the legs and ankles, and changes in urination patterns. Over time, the kidneys may lose more of their filtering ability, leading to the accumulation of waste products in the body. This can result in more severe symptoms and complications if not managed appropriately.