Pharmacokinetics of Entospletinib in Adults With Normal and Impaired Liver Function

Oncology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02521376
• Other study ID #: GS-US-339-1631
• Secondary ID: 2016-003266-98
• Status: Completed
• Phase: Phase 1
• Start date: November 16, 2015
• Est. completion date: October 25, 2017

Study information

• Verified date: May 2019
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 25, 2017
• Est. primary completion date: October 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Oncology

Intervention

Drug:
• Entospletinib
Entospletinib 100 mg tablet administered orally

Locations

Country	Name	City	State
Germany	APEX GmBH	Munich
New Zealand	Auckland Clinical Studies	Auckland
United States	Clinical Pharmacology of Miami, Inc. (CPMI)	Miami	Florida
United States	DaVita Clinical Research	Minneapolis	Minnesota
United States	Orlando Clinical Research Center	Orlando	Florida
United States	The Texas Liver Institute	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Germany,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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
Primary	Pharmacokinetic (PK) Parameter: Cmax of ENTO	Cmax is defined as the maximum concentration of drug.	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	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.	Baseline up to Day 9 plus 30 days
Secondary	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.	Baseline up to Day 9 plus 30 days