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