Hematinics

All Drugs and Chemicals

Liver Extracts

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

Entospletinib 100 mg tablet administered orally

Entospletinib

Gilead Study Director

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.

Pharmacokinetics of Entospletinib in Adults With Normal and Impaired Liver Function

A Phase 1, Open-Label, Multiple Dose Study to Evaluate the Pharmacokinetics of Entospletinib in Subjects With Normal and Impaired Hepatic Function

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

Cmax is defined as the maximum concentration of drug.

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.

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.

Gilead Sciences

Safety Analysis Set included all randomized participants who received at least one dose of study drug.

Participants with severe hepatic impairment received entospletinib (ENTO) 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.

Severe Hepatic Impairment

Participants with moderate hepatic impairment received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.

Moderate Hepatic Impairment

Participants with mild hepatic impairment received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.

Mild Hepatic Impairment

Participants with normal hepatic function received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.

Healthy Control

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

New Zealand

United States

Germany

Region of Enrollment

Gilead Clinical Study Information Center

Participants with moderate hepatic impairment who are smokers received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.

Cohort 1: Moderate Hepatic Impairment Smoking

Participants with moderate hepatic impairment who are non-smokers received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.

Cohort 1: Moderate Hepatic Impairment Non-smoking

Participants with normal hepatic function who are smokers received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.

Cohort 1: Healthy Control Matched to Smoking

Participants with normal hepatic function who are non-smokers received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.

Cohort 1: Healthy Control Matched to Non-smoking

Participants with severe hepatic impairment received ENTO 100 mg tablet twice daily on Days 1-4, and 1 morning dose only on Day 5.

Cohort 2: Severe Hepatic Impairment

Cohort 2: Healthy Control

Cohort 3: Mild Hepatic Impairment

Cohort 3: Healthy Control

Participants in the PK Analysis Set (all enrolled participants who received at least one dose of ENTO and had at least one evaluable PK concentration data value reported by the PK lab) with available data were analyzed. Healthy control participants may participate in more than one cohorts.

Pharmacokinetic (PK) Parameter: AUCtau of ENTO

Participants in the PK Analysis Set with available data were analyzed. Healthy control participants may participate in more than one cohorts.

Pharmacokinetic (PK) Parameter: Cmax of ENTO

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

Participants in the Safety Analysis Set were analyzed.

Spots Global Cancer Trial Database for Pharmacokinetics of Entospletinib in Adults With Normal and Impaired Liver Function

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial