Phase 1 Study of REN001 Single‑Dose Pharmacokinetics in Adults with Normal, Mild, Moderate, or Severe Liver Impairment

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What is this study about?

The trial investigates the drug Mavodelpar, identified by the code name REN001, in people who have Impaired Hepatic Function. This condition means the liver does not work as well as normal, which can change how medicines are handled by the body.

The purpose of the study is to determine how liver problems affect the way a single 25 mg oral capsule of the medication is processed. Participants are divided into four groups based on liver health: one group with normal liver function, and three groups with mild, moderate, or severe liver impairment as measured by the Child-Pugh scoring system. Each person receives one dose and then provides blood samples over several hours while doctors check vital signs and perform safety tests.

Researchers will look at the drug’s pharmacokinetics, which is a term for how quickly the body absorbs, distributes, breaks down, and removes the medication. They will also monitor for any AEs, which are unwanted effects that might occur. Additional checks include laboratory tests, blood pressure, heart rate, and a simple heart rhythm recording to ensure participants remain safe.

Who Can Join the Study?

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
CRU Hungary Kft. god Hungary

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Hungary Hungary
Not recruiting
01.06.2023

Trial locations

Trial ID:
2023-504007-91-00
Protocol code:
REN001-108
Trial Phase:
Human Pharmacology (Phase I) – Other

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