NCT02344303

Study of the Effects of TRV130, at Therapeutic and Supra Therapeutic Doses, on QTc Intervals

A Single-dose, Open-label, Fixed Sequence, Two Period Cross Over Study to Assess the Tolerability of a Supra Therapeutic Dose of TRV130 Followed by A Single Dose, Randomized, Double Blind, Comparative, Positive and Placebo Controlled, Four Period Cross-over Study of the Effects of TRV130, at Therapeutic and Supra Therapeutic Doses, on the QTc Intervals in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Trevena Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Assess the electrocardiogram effects of TRV130 relative to placebo at therapeutic and supratherapeutic doses.

Detailed description

* Part A of the study will assess clinical safety data of TRV130 * Part B of the study will assess the effect of single dose TRV130 on QTc

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	TRV130
DRUG	Moxifloxacin
DRUG	Placebo

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-05-01
• Completion: 2015-10-01
• First posted: 2015-01-22
• Last updated: 2017-05-12

Locations

1 site across 1 country: United States