Long QT Syndrome
Conditions
Keywords
drug-induced long QT syndrome, DILQTS, prolonged QT
Brief summary
This study will evaluate the effect of oral GS-6615 on QTc interval in healthy adults with dofetilide-induced QTc prolongation.
Interventions
DRUGGS-6615
GS-6615 tablets administered orally
DRUGPlacebo to match GS-6615
Placebo to match GS-6615 tablets administered orally
DRUGPlacebo to match dofetilide
Placebo to match dofetilide capsules administered orally
DRUGDofetilide
Dofetilide 500 μg capsules administered orally according to the current prescribing information
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in daytime QT interval corrected for heart rate using the Fridericia formula (QTcF) | Up to 6 days | — |
| Pharmacokinetic (PK) profiles of GS-6615 and dofetilide | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events, clinical laboratory test results, vital sign measurements, and electrocardiogram (ECG) data | Up to 6 days | This endpoint will measure the safety and tolerability profile of GS-6615. |
Countries
United States
Outcome results
None listed