Clinical trial NCT02365532 (phase 1, status: completed)
Conditions: long qt syndrome
ICD codes: I45.81
Drugs: gs-6615, placebo to match gs-6615, placebo to match dofetilide, dofetilide
SMILES: FC(F)(F)OC1=CC=C(C=C1)C1=CC=C2OCCN(CC3=NC=CC=N3)C(=O)C2=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN(CCOC1=CC=C(NS(C)(=O)=O)C=C1)CCC1=CC=C(NS(C)(=O)=O)C=C1
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

          -  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