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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02412098




Registration number
NCT02412098
Ethics application status
Date submitted
11/03/2015
Date registered
8/04/2015
Date last updated
29/04/2016

Titles & IDs
Public title
Pharmacokinetics of Eleclazine in Adults With Normal and Impaired Hepatic Function
Scientific title
A Phase 1, Open-Label, Parallel-Group, Adaptive, Single Dose Study to Evaluate the Pharmacokinetics of GS-6615 in Subjects With Normal and Impaired Hepatic Function
Secondary ID [1] 0 0
2014-005266-30
Secondary ID [2] 0 0
GS-US-372-1048
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long QT Syndrome 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cardiovascular 0 0 0 0
Other cardiovascular diseases

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

Experimental: Moderate hepatic impairment - Participants with moderate hepatic impairment and matched healthy controls will receive a single dose of eleclazine 30 mg (5 x 6 mg tablets).

Experimental: Severe hepatic impairment - Participants with severe hepatic impairment and matched healthy controls will receive a single dose of eleclazine 30 mg (5 x 6 mg tablets).

Experimental: Mild hepatic impairment - Participants with mild hepatic impairment and matched healthy controls will receive a single dose of eleclazine 30 mg (5 x 6 mg tablets).


Treatment: Drugs: Eleclazine
Eleclazine tablets administered orally

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PK Parameter: AUC_0-inf of eleclazine and its metabolite GS-623134 - AUC_0-inf is defined as the concentration of drug over time from time zero to infinity.
Timepoint [1] 0 0
Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72, 96, 120 hours, 15, 29, 43, and 57 days postdose
Primary outcome [2] 0 0
PK Parameter: Cmax of eleclazine and its metabolite GS-623134 - Cmax is defined as the maximum concentration of drug.
Timepoint [2] 0 0
Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72, 96, 120 hours, 15, 29, 43, and 57 days postdose
Secondary outcome [1] 0 0
Incidence of adverse events
Timepoint [1] 0 0
Up to 58 days
Secondary outcome [2] 0 0
Proportion of participants with laboratory abnormalities
Timepoint [2] 0 0
Up to 58 days

Eligibility
Key inclusion criteria
All participants:

- Be a nonsmoker or consume < 20 cigarettes per day

- Have a calculated body mass index (BMI) from 18 to 36 kg/m^2, inclusive, at study
screening

- Have a creatinine clearance (CrCl) = 60 mL/min (using the Cockcroft-Gault method)
based on serum creatinine and actual body weight as measured at screening

- Have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that
are considered clinically insignificant by the investigator

- Screening labs within defined thresholds

Participants with mild, moderate, or severe hepatic impairment must also meet the following
additional inclusion criteria:

- Must have diagnosis of chronic (> 6 months), stable hepatic impairment with no
clinically significant changes within 3 months (90 days) prior to study drug
administration (Day 1)

- Individuals with severe hepatic impairment must have a score on the
Child-Pugh-Turcotte scale of 10-15 at screening. If an individual's score changes
during the course of the study, the score at screening will be used for
classification.

- Individuals with moderate hepatic impairment must have a score on the
Child-Pugh-Turcotte scale of 7-9 at screening. If an individual's score changes during
the course of the study, the score at Screening will be used for classification.

- Individuals with mild hepatic impairment must have a score on the Child-Pugh-Turcotte
scale of 5-6 at screening. If an individual's score changes during the course of the
study, the score at screening will be used for classification.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Pregnant or lactating females

- History of meningitis or encephalitis, epilepsy, seizures, migraines, tremors,
myoclonic jerks, narcolepsy, obstructive sleep apnea, anxiety, syncope, head injuries
or a family history of seizures

- Presence or history of cardiovascular disease (including history of myocardial
infarction based on ECG and/or clinical history, any history of ventricular
tachycardia, congestive heart failure, cardiomyopathy, or left ventricular ejection
fraction < 40%), cardiac conduction abnormalities, a family history of Long QT
Syndrome, or unexplained death in an otherwise healthy individual between the ages of
1 and 30 years

- Syncope, palpitations, or unexplained dizziness

- Implanted defibrillator or pacemaker

- Are unable to comply with study requirements or are otherwise believed, by the study
investigator, to be inappropriate for study participation for any reason

- Active hepatitis B virus (HBV) infection. Individuals who have HBsAg are ineligible

- Requires paracentesis > 1 time per month

- Severe (grade 3 or 4) encephalopathy as judged by the investigator

- History of gastric or esophageal variceal bleeding within the past 6 months and for
which varices have not been adequately treated with medication and/or surgical
procedures

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Missouri
Country [4] 0 0
Germany
State/province [4] 0 0
München
Country [5] 0 0
Moldova, Republic of
State/province [5] 0 0
Chisinau
Country [6] 0 0
New Zealand
State/province [6] 0 0
Auckland
Country [7] 0 0
Romania
State/province [7] 0 0
Bucharest

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

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral
dose of eleclazine in participants with normal and impaired hepatic function. Participants in
the healthy control group will be matched to participants with impaired hepatic function by
age (± 5 years), gender, and body mass index (± 10%).
Trial website
https://clinicaltrials.gov/show/NCT02412098
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Patrick Yue, MD
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

Summary results
Other publications