Inavolisib
DrugParticipants will receive a single oral dose of inavolisib
NCT Number: NCT07144111
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 1
Orange County Research Center, Lake Forest, California, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All participants:
Healthy participants (Cohort 1):
Participants with Hepatic Impairment (Cohorts 2 and 3):
Exclusion criteria
All participants:
Healthy participants (Cohort 1):
Participants with Hepatic Impairment (Cohorts 2 and 3):
Participants will receive a single oral dose of inavolisib
Time frame: Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
Time frame: Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
Time frame: Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
Time frame: Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
Time frame: Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
Time frame: Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
Time frame: From Baseline up to Follow-up (Day 8)
Contact information is provided by the study sponsor or research team.
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
CONTACT
Reference Study ID Number: GP45942 https://forpatients.roche.com/ No attachments to email below.
CONTACT
888-662-6728 (U.S. and Canada)
Genentech, Inc.
Industry
A Phase 1, Open-Label, Single-Dose Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics of Inavolisib
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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