Safety and how the body handles RO7795081 in people with kidney problems

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional study evaluating pharmacokinetics and safety of a single oral dose of RO7795081. Part 1 compares participants with normal kidney function to those with severe renal impairment or kidney failure not on dialysis. Part 2, if opened, may include additional groups with mild or moderate impairment and normal function. The study uses PK sampling and safety monitoring to understand how kidney impairment affects drug disposition and tolerability. Enrollment is limited to adults with stable renal function and the ability to comply with study procedures, conducted at multiple Florida sites.

Why it matters

Who can join: the full rules

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

Where it's running

• Panax Clinical Research, LLC
  Miami Lakes, Florida, United States Recruiting
• Orlando Clinical Research Center
  Orlando, Florida, United States Recruiting
• GCP Research - Florida
  St. Petersburg, Florida, United States Recruiting

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.