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A Phase 1, Open-Label, Single-Dose Study To Evaluate The Pharmacokinetics Of Mavodelpar In Subjects With Impaired Hepatic Function

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504007-91-00
Acronym
REN001-108
Enrollment
32
Registered
2023-07-04
Start date
2023-07-06
Completion date
2023-11-20
Last updated
2023-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impaired Hepatic Function The study will enroll as following: · Group 1 (N =10) – Normal hepatic function (healthy subjects), single dose · Group 2 (N=8) – Mild hepatic impairment (Child-Pugh A - a score of 5 to 6), single dose · Group 3 (N=8) – Moderate hepatic impairment (Child-Pugh B a score of 7 to 9), single dose · Group 4 (N=6) – Severe hepatic impairment (Child-Pugh C a score of 10 to 15), single dose Healthy volunteers with normal hepatic function.

Interventions

None listed

Sponsors

Reneo Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Countries

Hungary

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026