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RECRUITING
NCT07741604
PHASE1

A Study Investigating the Safety of RO7795081 and How the Body Processes RO7795081 in People With Normal or Decreased Kidney Functions

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) and safety of RO7795081, following a single oral dose in participants with renal impairment compared with participants with normal renal function. In Part 1, participants with normal renal function and participants with severe renal impairment or kidney failure not receiving dialysis will receive RO7795081. Part 2 is optional and will be conducted based on the results of Part 1. If Part 2 is implemented, additional participants with normal renal function and participants with mild or moderate renal impairment may be enrolled to receive RO7795081.

Official title: A Two-part, Non-randomized, Open-label, Parallel-group Study to Assess the Effect of Renal Impairment on the Pharmacokinetics and Safety of RO7795081 Following a Single Oral Dose of RO7795081

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-09-09

Completion Date

2028-02-01

Last Updated

2026-10-09

Healthy Volunteers

Yes

Interventions

DRUG

RO7795081

Participants will receive RO7795081 as per the schedule described in the protocol.

Locations (3)

Panax Clinical Research, LLC

Miami Lakes, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

GCP Research - Florida

St. Petersburg, Florida, United States