Study to Evaluate the Effect of Eleclazine on QT, Safety, and Tolerability in Participants With Long QT2 Syndrome
NCT02365506 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2020-12-30
Summary
The primary objective of the study is to evaluate the effect of oral eleclazine (formerly GS-6615) on corrected QT (QTc) interval in participants with long QT2 syndrome.
Conditions
- LQT2 Syndrome
Interventions
- DRUG
-
Eleclazine
Tablets administered orally in a single dose
- DRUG
-
Placebo to match tablets administered orally in a single dose
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Gilead Study Director · Gilead Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-07-20
- Primary Completion
- 2016-05-13
- Completion
- 2016-06-13
- FDA Drug
- Yes
Countries
- United States
Study Locations
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