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

NCT02365532 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-05-20

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Kimberly B Patel, MD · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02365532 on ClinicalTrials.gov