Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-01-02 @ 11:47 AM
Study NCT ID:
NCT02344303
Status:
COMPLETED
Last Update Posted:
2017-05-12
First Post:
2015-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Effects of TRV130, at Therapeutic and Supra Therapeutic Doses, on QTc Intervals
Sponsor:
Trevena Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
* Part B of the study will assess the effect of single dose TRV130 on QTc
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: