Pharmacokinetics of Entospletinib in Adults With Normal and Impaired Liver Function

Gilead Sciences56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Oncology

Interventions

EntospletinibDRUG

Entospletinib 100 mg tablet administered orally

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (6)

Clinical Pharmacology of Miami, Inc. (CPMI)

Miami, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

DaVita Clinical Research

Minneapolis, Minnesota, United States

The Texas Liver Institute

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Pharmacokinetic (PK) Parameter: AUCtau of ENTO

AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

Time frame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60, 72, 84, and 96 hours postdose on Day 5

Pharmacokinetic (PK) Parameter: Cmax of ENTO

Cmax is defined as the maximum concentration of drug.

Time frame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60, 72, 84, and 96 hours postdose on Day 5

Secondary Outcomes

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

TEAEs are defined as events that meet one of the following criteria: * Any adverse events (AEs) with onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or * Any AEs leading to premature discontinuation of study drug.

Time frame: Baseline up to Day 9 plus 30 days

Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities

Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each subject.

Time frame: Baseline up to Day 9 plus 30 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.