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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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 - Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 - History of cardiovascular, neurologic, psychiatric, or infectious disease - History of hypersensitivity to any of the excipients in Glucagon-like Peptide-1 (GLP-1) agonists - Bipolar disorder, schizophrenia, or any other serious psychiatric condition - Type 1 diabetes or poorly controlled Type 2 diabetes - Current or recent participation in another clinical study - Pregnancy or breastfeeding - Positive Human Immunodeficiency Virus (HIV), hepatitis B, hepatitis C, or tuberculosis test - History of alcohol or substance abuse

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group 1: Participants with Normal Renal Function, RO7795081 		Participants with normal renal function will receive a single oral dose of RO7795081.
  • Drug: RO7795081
    Participants will receive RO7795081 as per the schedule described in the protocol.
    Other names:
    • CT-996
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.
  • Drug: RO7795081
    Participants will receive RO7795081 as per the schedule described in the protocol.
    Other names:
    • CT-996
Experimental
Group 3: Participants with Moderate Renal Impairment, RO7795081 		Participants with moderate renal impairment will receive a single oral dose of RO7795081.
  • Drug: RO7795081
    Participants will receive RO7795081 as per the schedule described in the protocol.
    Other names:
    • CT-996
Experimental
Group 4: Participants with Mild Renal Impairment, RO7795081 		Participants with mild renal impairment will receive a single oral dose of RO7795081.
  • Drug: RO7795081
    Participants will receive RO7795081 as per the schedule described in the protocol.
    Other names:
    • CT-996

Recruiting Locations

Panax Clinical Research, LLC
Miami Lakes, Florida 33014

GCP Research - Florida
St. Petersburg, Florida 33705

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: BP46039 https://forpatients.roche.com/ No attachments to email below.
888-662-6728
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.