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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504780-17-00

Acronym

GS-US-611-6472

Enrollment

Registered

2024-01-15

Start date

2024-03-19

Completion date

2024-06-14

Last updated

2024-01-15

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

Conditions

Renal Impairment

Brief summary

Plasma PK parameters Cmax, AUClast, and AUCinf of GS-441524 (ODV metabolite)

Detailed description

Incidence of AEs and laboratory abnormalities., Urine concentrations of GS-441524 (ODV metabolite) and its urine PK parameters (Ae, CLr, and %Fe).

Interventions

DRUGGS-5245 tablets 175 mg

DRUGGS-5245 tablets 350 mg

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Plasma PK parameters Cmax, AUClast, and AUCinf of GS-441524 (ODV metabolite)	—

Secondary

Measure	Time frame
Incidence of AEs and laboratory abnormalities., Urine concentrations of GS-441524 (ODV metabolite) and its urine PK parameters (Ae, CLr, and %Fe).	—

Countries

Germany

Outcome results

None listed

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