A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib

Recruiting Phase 1 Interventional Study
Hepatic Impairment
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
32 (estimated)
Sponsor
Genentech, Inc. · Industry
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About This Trial

This open-label study will evaluate the effect on the pharmacokinetics (PK), safety, and tolerability of a single oral dose of inavolisib in participants with moderate or severe hepatic impairment compared with demographically matched healthy participants with normal hepatic function.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: All participants: * Body Mass Index 18.0 to 40.0 kilogram per meter square (kg/m\^2), inclusive, and body weight \>=45 kg. * Negative hepatitis B surface antigen (HBsAg) test * Positive hepatitis B surface antibody (HBsAb) test or negative HBsAb * Negative HIV (Human Immunodefi…
Contacts

Reference Study ID Number: GP45942 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S. and Canada)

global-roche-genentech-trials@gene.com

CONTACT

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT