Renal Impairment
Conditions
Brief summary
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.
Interventions
DRUGRO7795081
Participants will receive RO7795081 as per the schedule described in the protocol.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Plasma Concentration (Cmax) of RO7795081 | At prespecified timepoints from Day 1 to Day 14 |
| Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Last Measurable Concentration (AUClast) of RO7795081 | At prespecified timepoints from Day 1 to Day 14 |
| AUC From Time 0 to Infinity (AUCinf) of RO7795081 | At prespecified timepoints from Day 1 to Day 14 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and Severity of Adverse Events | Baseline up to Day 14 |
Countries
United States
Contacts
CONTACTReference Study ID Number: BP46039 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed