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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
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
Conditions
Interventions
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