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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02521376




Registration number
NCT02521376
Ethics application status
Date submitted
10/08/2015
Date registered
13/08/2015
Date last updated
26/07/2019

Titles & IDs
Public title
Pharmacokinetics of Entospletinib in Adults With Normal and Impaired Liver Function
Scientific title
A Phase 1, Open-Label, Multiple Dose Study to Evaluate the Pharmacokinetics of Entospletinib in Subjects With Normal and Impaired Hepatic Function
Secondary ID [1] 0 0
2016-003266-98
Secondary ID [2] 0 0
GS-US-339-1631
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oncology 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Entospletinib

Experimental: Cohort 1 (Moderate Hepatic Impairment) - Entospletinib administered twice daily on Days 1-4, and 1 morning dose only on Day 5.

Experimental: Cohort 2 (Severe Hepatic Impairment) - Entospletinib administered twice daily on Days 1-4, and 1 morning dose only on Day 5.

Experimental: Cohort 3 (Mild Hepatic Impairment) - Entospletinib administered twice daily on Days 1-4, and 1 morning dose only on Day 5.


Treatment: Drugs: Entospletinib
Entospletinib 100 mg tablet administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pharmacokinetic (PK) Parameter: AUCtau of ENTO
Timepoint [1] 0 0
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 outcome [2] 0 0
Pharmacokinetic (PK) Parameter: Cmax of ENTO
Timepoint [2] 0 0
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 outcome [1] 0 0
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Baseline up to Day 9 plus 30 days
Secondary outcome [2] 0 0
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Timepoint [2] 0 0
Baseline up to Day 9 plus 30 days

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/11/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/10/2017
Sample size
Target
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Germany
State/province [4] 0 0
Munich
Country [5] 0 0
New Zealand
State/province [5] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02521376
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries