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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorHoffmann-La Roche

About this trial

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.

Eligibility criteria

Qualifiers

Ability and willingness to comply with all aspects of the protocol including completion of assessments for the duration of the study

Estimated Glomerular Filtration Rate (eGFR) calculated using the Body Surface Area (BSA)-adjusted Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation

Participants with mild, moderate, or severe renal impairment/kidney failure and stable renal function

Participants with normal renal function matched to participants with renal impairment

Disqualifiers

Any condition or disease detected during the medical interview/physical examination that would render the participant unsuitable for the study, place the participant at undue risk, or interfere with the ability of the participant to complete the study in the opinion of the Investigator

History or evidence of any medical condition other than renal impairment capable of significantly altering the absorption, metabolism, or elimination of drugs

Surgical history of the gastrointestinal (GI) tract affecting gastric motility or altering the GI tract (with the exception of uncomplicated appendectomy and cholecystectomy)

History of malignancy in the past 5 years, except for fully treated local basal carcinoma, or fully treated carcinoma in situ of cervix

Trial design

Treatments tested in this trial

  • RO7795081

Treatment groups

60 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators