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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGenentech, Inc.

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.

Eligibility criteria

Qualifiers

Body Mass Index 18.0 to 40.0 kilogram per meter square (kg/m²), 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 Immunodeficiency Virus) test

Disqualifiers

History of Type 1 diabetes or Type 2 Diabetes that is insulin-dependent or requires ongoing systemic treatment with two or more agents

Significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder

Significant illness, surgery, or hospitalization within 2 weeks prior to dosing.

History of gastro-intestinal surgery

Trial design

Treatments tested in this trial

  • Inavolisib

Treatment groups

32 Participants
are divided into 3 treatment groups

Sponsors and collaborators