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Trial record 10 of 74 for:    "Andersen-Tawil syndrome" OR "Long QT Syndrome"

Effect of Oral GS-6615 on Dofetilide-Induced QT Prolongation, Safety, and Tolerability in Healthy Adults

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ClinicalTrials.gov Identifier: NCT02365532
Recruitment Status : Completed
First Posted : February 19, 2015
Last Update Posted : May 20, 2015
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
This study will evaluate the effect of oral GS-6615 on QTc interval in healthy adults with dofetilide-induced QTc prolongation.

Condition or disease Intervention/treatment Phase
Long QT Syndrome Drug: GS-6615 Drug: Placebo to match GS-6615 Drug: Placebo to match dofetilide Drug: Dofetilide Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Oral GS-6615 on Dofetilide-Induced QT Prolongation, Safety, and Tolerability in Healthy Subjects
Study Start Date : February 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015


Arm Intervention/treatment
Placebo Comparator: Placebo to match GS-6615
Placebo to match GS-6615 + dofetilide or placebo to match dofetilide twice daily
Drug: Placebo to match GS-6615
Placebo to match GS-6615 tablets administered orally

Drug: Placebo to match dofetilide
Placebo to match dofetilide capsules administered orally

Drug: Dofetilide
Dofetilide 500 μg capsules administered orally according to the current prescribing information

Experimental: GS-6615
GS-6615 or placebo to match GS-6615 + dofetilide or placebo to match dofetilide twice daily
Drug: GS-6615
GS-6615 tablets administered orally

Drug: Placebo to match GS-6615
Placebo to match GS-6615 tablets administered orally

Drug: Placebo to match dofetilide
Placebo to match dofetilide capsules administered orally

Drug: Dofetilide
Dofetilide 500 μg capsules administered orally according to the current prescribing information




Primary Outcome Measures :
  1. Change in daytime QT interval corrected for heart rate using the Fridericia formula (QTcF) [ Time Frame: Up to 6 days ]
  2. Pharmacokinetic (PK) profiles of GS-6615 and dofetilide [ Time Frame: Predose and postdose on Days -2 through Day 4 ]
    This endpoint will measure the plasma PK profiles of GS-6615 and dofetilide. PK parameters that will be measured include Cmax, Tmax, AUC_0-24, and AUC_0-tlast.


Secondary Outcome Measures :
  1. Incidence of adverse events, clinical laboratory test results, vital sign measurements, and electrocardiogram (ECG) data [ Time Frame: Up to 6 days ]
    This endpoint will measure the safety and tolerability profile of GS-6615.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs
  • Have a calculated body mass index (BMI) from 18 to 30 kg/m^2, inclusive, at study screening
  • Have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant and which do not interfere with the ability to interpret the QT interval in the opinion of the investigator in consultation with the medical monitor

Exclusion Criteria:

  • History of meningitis or encephalitis, epilepsy, seizures (known or suspected), migraines, tremors, myoclonic jerks, sleep disorder, anxiety, syncope, head injuries, or a family history of seizures
  • Have any serious or active medical or psychiatric illness (including depression) which, in the opinion of the investigator, would interfere with treatment, assessment, or compliance with the protocol. This would include renal, cardiac, hematological, hepatic, pulmonary (including chronic asthma), endocrine (including diabetes), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment.
  • Presence or history of cardiovascular disease, including structural heart disease, myocardial infarction (by ECG and/or clinical history), history of ventricular tachycardia or torsade de pointes, heart failure or cardiomyopathy (by clinical history and/or left ventricular ejection fraction < 40%), presence of cardiac conduction abnormalities, a family history of Long QT or Brugada Syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years
  • Additional cardiovascular-specific exclusion criteria include findings on screening ECG of:

    • QTcF interval > 430 msec
    • PR interval > 220 msec
    • QRS duration > 110 msec
    • Second- or third-degree atrioventricular block
    • Complete left or right bundle branch block or incomplete right bundle branch block
    • Resting heart rate < 40 or > 100 beats per minute (bpm)
    • Pathological Q waves (defined as Q wave > 40 msec)
    • Ventricular pre-excitation
    • More than 2 ectopic beats
  • Syncope, palpitations, or unexplained dizziness

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): NCT02365532


Locations
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United States, Wisconsin
Spaulding Clinical Research, LLC
West Bend, Wisconsin, United States, 53095
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Kimberly B Patel, MD Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02365532     History of Changes
Other Study ID Numbers: GS-US-372-1666
First Posted: February 19, 2015    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: May 2015

Keywords provided by Gilead Sciences:
drug-induced long QT syndrome
DILQTS
prolonged QT

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
Dofetilide
Anti-Arrhythmia Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action