A Phase 1, open-label, single-dose study to evaluate the effect of moderate or severe renal impairment on the pharmacokinetics of inavolisib

F. Hoffmann-La Roche Ltd0 sites32 target enrollmentNovember 17, 2023

Overview

No summary available.

Registry

who.int

Start Date

November 17, 2023

End Date

October 22, 2024

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Participants must have a body weight of at least 45 kilograms (kg), and a body mass index (BMI) within the range of 18 \- 40 kilograms per square meter (kg/m2\) (inclusive).
•2\. Negative hepatitis panel (hepatitis B virus core antibody, hepatitis B surface antigen, and hepatitis C virus antibody) and negative human immunodeficiency virus (HIV) antibody screens.
•Additional inclusion criteria for participants with normal renal function:
•1\. Participants must be in reasonably good health for their age group.
•2\. Estimated glomerular filtration rate (eGFR) of 90 millilitres per minute (mL/min), as calculated using 2021 Chronic Kidney Disease\-Epidemiology Collaboration (CKD\-EPI) creatinine equation at screening and confirmed at Day \-1\.
•3\. Matched to participants with renal impairment in sex, age (±10 years), and body weight (±15%).
•Additional inclusion criteria for participants with moderate renal impairment:
•1\. Participants with moderate renal impairment must have eGFR 30\-59 mL/min
•2\. Participants must have a stable renal function, defined as either:
•2\.1\. If the time interval between Screening and Check\-in (Day \-1\) is greater than 7 days, eGFR value on Day \-1 is within 20% of eGFR value at Screening, or

•1\. History of Type 1 diabetes or Type 2 diabetes requiring ongoing systemic treatment with 2 or more agents
•2\. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder
•3\. Clinically significant and active liver disease, e.g., hepatitis, cirrhosis, or confirmed liver enzyme elevations.
•4\. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs except that appendectomy and hernia repair will be allowed.
•5\. Malabsorption syndrome or other condition that would interfere with enteral absorption. This includes gastric bypass surgery; gastric band surgery is allowed.
•6\. History of active or latent tuberculosis (TB), regardless of treatment history, or positive QuantiFERON® TB Gold test.
•Additional exclusion criteria for participants with normal renal function:
•1\. Significant history or clinical manifestation of renal injury or disease (as determined by the investigator).
•2\. Uncomplicated cholecystectomy more than 5 years prior to enrolment is allowed unless the participant was \= 40 years old at the time of procedure; any cholecystectomy within 5 years of enrolment is exclusionary.
•Additional exclusion criteria for participants with moderate and severe renal impairment: