A phase 1, open-label, single-center study to investigate the absorption, metabolism, excretion, and absolute bioavailability of a single oral dose of [14C]-labeled inavolisib and an iv tracer dose of [13C6]-labeled inavolisib in a single cohort of healthy volunteers

Genentech, Inc0 sites8 target enrollmentMay 4, 2021

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: The absorption, metabolism, excretion, and bioavailability of a PI3K inhibitor drug in healthy volunteers
Sponsor: Genentech, Inc
Enrollment: 8
Status: Completed
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

May 4, 2021

End Date

April 23, 2021

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Males, who are sterile, and females of non\-childbearing potential
•2\. Aged between 18 and 65 years, inclusive
•3\. \=3 male volunteers
•4\. Body mass index (BMI) between 18\.5 and 32\.0 kg/m², inclusive
•5\. In good health, determined by no clinically significant findings from medical history, 12\-lead ECG, vital signs, and taking no chronic medications
•6\. Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator. Evaluations will include a chemistry panel (fasted at least 8 h), complete blood count, coagulation testing (including prothrombin time, international normalized ratio, and activated partial thromboplastin time), and urinalysis with complete microscopic analysis, and glycosylated hemoglobin.
•7\. Negative test for selected drugs of abuse (does not include alcohol) at screening visit and day \-1 (including alcohol)
•8\. Negative hepatitis panel (hepatitis B surface antigen and hepatitis C virus antibody) and negative human immunodeficiency virus (HIV) antibody screens
•9\. Negative screening test for latent mycobacterium tuberculosis (TB) infection using QuantiFERON® TB Gold
•10\. Receive an explanation of the mandatory WGS component of the study

•1\. History of type 1 diabetes or type 2 diabetes requiring systemic treatment
•2\. More than 1 of the following risk factors
•2\.1\. BMI \>32\.0 kg/m²
•2\.2\. Fasting blood glucose\=125 mg/dl (7\.0 mmol/l)
•2\.3\. Glycosylated hemoglobin (HbA1C) \=6\.5%
•3\. Have a PR interval \>210 ms, QRS complex \>120 ms, or QTc interval \>450 ms for males, \>470 ms for females
•4\. History or presence of an abnormal ECG that, in the Investigator’s opinion, is clinically significant
•5\. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder (as determined by the Investigator)
•6\. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator
•7\. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs with the exception of appendectomy and hernia repair surgery