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Trial record 14 of 74 for:    "Andersen-Tawil syndrome" OR "Long QT Syndrome"

Pharmacokinetics of Eleclazine in Adults With Normal and Impaired Hepatic Function

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ClinicalTrials.gov Identifier: NCT02412098
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : April 29, 2016
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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%).

Condition or disease Intervention/treatment Phase
Long QT Syndrome Drug: Eleclazine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : March 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
Drug: Eleclazine
Eleclazine tablets administered orally
Other Name: GS-6615

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).
Drug: Eleclazine
Eleclazine tablets administered orally
Other Name: GS-6615

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).
Drug: Eleclazine
Eleclazine tablets administered orally
Other Name: GS-6615




Primary Outcome Measures :
  1. PK Parameter: AUC_0-inf of eleclazine and its metabolite GS-623134 [ Time Frame: 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 ]
    AUC_0-inf is defined as the concentration of drug over time from time zero to infinity.

  2. PK Parameter: Cmax of eleclazine and its metabolite GS-623134 [ Time Frame: 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 ]
    Cmax is defined as the maximum concentration of drug.


Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Up to 58 days ]
  2. Proportion of participants with laboratory abnormalities [ Time Frame: Up to 58 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02412098


Locations
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United States, Florida
Miami, Florida, United States
Orlando, Florida, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, Missouri
Kansas City, Missouri, United States
Germany
München, Germany
Moldova, Republic of
Chisinau, Moldova, Republic of
New Zealand
Auckland, New Zealand
Romania
Bucharest, Romania
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Patrick Yue, MD Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02412098     History of Changes
Other Study ID Numbers: GS-US-372-1048
2014-005266-30 ( EudraCT Number )
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: April 2016

Keywords provided by Gilead Sciences:
Hepatic Impairment

Additional relevant MeSH terms:
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Long QT Syndrome
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Pathologic Processes