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

ConditionHepatic Impairment
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Inavolisib

    Drug

    Participants will receive a single oral dose of inavolisib

Treatment groups

32 Participants
are divided into 3 treatment groups
Group A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Group C: Cohort 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum Observed Concentration (Cmax) 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
2

Area Under Curve (AUC) from Hour 0 to the Last Measurable Concentration (AUC [0-t]) 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
3

AUC from Zero to Infinity (AUC [0-inf]) Extrapolated 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
4

Geometric Mean Ratio of Cmax 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

Secondary outcomes

1

Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)

Time frame
From Baseline up to Follow-up (Day 8)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genentech, Inc.

Lead sponsor

Source ClinicalTrials.gov
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