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

NCT ID: NCT02365532

Last Updated: 2015-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-05-31

Brief Summary

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

Conditions

Long QT Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo to match GS-6615

Placebo to match GS-6615 + dofetilide or placebo to match dofetilide twice daily

Group Type: PLACEBO_COMPARATOR

Placebo to match GS-6615

Intervention Type: DRUG

Placebo to match GS-6615 tablets administered orally

Placebo to match dofetilide

Intervention Type: DRUG

Placebo to match dofetilide capsules administered orally

Dofetilide

Intervention Type: DRUG

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

GS-6615

GS-6615 or placebo to match GS-6615 + dofetilide or placebo to match dofetilide twice daily

Group Type: EXPERIMENTAL

GS-6615

Intervention Type: DRUG

GS-6615 tablets administered orally

Placebo to match GS-6615

Intervention Type: DRUG

Placebo to match GS-6615 tablets administered orally

Placebo to match dofetilide

Intervention Type: DRUG

Placebo to match dofetilide capsules administered orally

Dofetilide

Intervention Type: DRUG

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

Interventions

GS-6615

GS-6615 tablets administered orally

Intervention Type: DRUG

Placebo to match GS-6615

Placebo to match GS-6615 tablets administered orally

Intervention Type: DRUG

Placebo to match dofetilide

Placebo to match dofetilide capsules administered orally

Intervention Type: DRUG

Dofetilide

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

Intervention Type: DRUG

Eligibility 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kimberly B Patel, MD

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Spaulding Clinical Research, LLC

West Bend, Wisconsin, United States

Countries

United States

Other Identifiers

GS-US-372-1666

Identifier Type: -

Identifier Source: org_study_id