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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

NCT07741604 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-03

No results posted yet for this study

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.

Conditions

  • Renal Impairment

Interventions

DRUG

RO7795081

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-03
Primary Completion
2028-02-01
Completion
2028-02-01
FDA Drug
Yes

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07741604 on ClinicalTrials.gov