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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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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