Pharmacokinetics of Entospletinib in Adults With Normal and Impaired Liver Function

Gilead Sciences

Status and phase: Completed; Phase 1

Conditions: Oncology

Treatments: Drug: Entospletinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02521376

GS-US-339-1631

2016-003266-98 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this study is to evaluate the pharmacokinetics of entospletinib (ENTO) and/or its metabolites (if applicable) in participants with impaired hepatic function (stratified by smoking status, as appropriate) relative to matched, healthy controls.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Calculated body mass index from 18 to 40 kg/m^2
• Not pregnant
• Normal electrocardiogram
• Participants with impaired liver function must be sufficiently healthy based upon medical history and physical examination, vital signs, and screening laboratory evaluations.

Key Exclusion Criteria:

• Participation in another clinical study (current or within last 30 days)
• HIV, hepatitis B virus, or active hepatitis C virus infection

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 3 patient groups

Cohort 1 (Moderate Hepatic Impairment)

Experimental group

Description:

Entospletinib administered twice daily on Days 1-4, and 1 morning dose only on Day 5.

Treatment:

Drug: Entospletinib

Cohort 2 (Severe Hepatic Impairment)

Experimental group

Description:

Entospletinib administered twice daily on Days 1-4, and 1 morning dose only on Day 5.

Treatment:

Drug: Entospletinib

Cohort 3 (Mild Hepatic Impairment)

Experimental group

Description:

Entospletinib administered twice daily on Days 1-4, and 1 morning dose only on Day 5.

Treatment:

Drug: Entospletinib