Health Trials

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

ConditionRenal Impairment
Trial statusRecruiting
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • RO7795081

    Drug

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

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: Group 1: Participants with Normal Renal Function, RO7795081Experimental treatment 1 intervention
Group B: Group 2: Participants with Severe Renal Impairment, RO7795081Experimental treatment 1 intervention
Group C: Group 3: Participants with Moderate Renal Impairment, RO7795081Experimental treatment 1 intervention
Group D: Group 4: Participants with Mild Renal Impairment, RO7795081Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum Plasma Concentration (Cmax) of RO7795081

Time frame
At prespecified timepoints from Day 1 to Day 14
2

Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Last Measurable Concentration (AUClast) of RO7795081

Time frame
At prespecified timepoints from Day 1 to Day 14
3

AUC From Time 0 to Infinity (AUCinf) of RO7795081

Time frame
At prespecified timepoints from Day 1 to Day 14

Secondary outcomes

1

Incidence and Severity of Adverse Events

Time frame
Baseline up to Day 14

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov
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