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

Part of paid clinical trials in Miami Lakes, Florida.

Sponsor
Hoffmann-La Roche
Study ID
NCT07741604
Phase
PHASE1
Status
Recruiting
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Conditions

  • Renal Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Aug 3, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Feb 1, 2028
Completion
Feb 1, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: Participants with Normal Renal Function, RO7795081
    Participants with normal renal function will receive a single oral dose of RO7795081.
  • Experimental: Group 2: Participants with Severe Renal Impairment, RO7795081
    Participants with severe renal impairment or kidney failure not receiving dialysis will receive a single oral dose of RO7795081.
  • Experimental: Group 3: Participants with Moderate Renal Impairment, RO7795081
    Participants with moderate renal impairment will receive a single oral dose of RO7795081.
  • Experimental: Group 4: Participants with Mild Renal Impairment, RO7795081
    Participants with mild renal impairment will receive a single oral dose of RO7795081.

Primary Outcome Measure

Maximum Plasma Concentration (Cmax) of RO7795081 [ Time Frame: At prespecified timepoints from Day 1 to Day 14 ]

Central Contacts

  • Reference Study ID Number: BP46039 https://forpatients.roche.com/ No attachments to email below.
    888-662-6728
    [email protected]
  • Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (2)

FacilityCityStateZIPSite coordinators
Panax Clinical Research, LLCMiami LakesFlorida33014-
GCP Research - FloridaSt. PetersburgFlorida33705-

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By research site
Panax Clinical Research, LLC· Miami Lakes, FLGCP Research - Florida· St. Petersburg, FL

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