Study of the Effects of TRV130, at Therapeutic and Supra... | NCT02344303

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

NCT02344303

Sponsor

Trevena Inc.

Status

Completed

Last Update Posted

May 12, 2017Actual

Enrollment

63Actual

Phase

Phase 1

Conditions

Healthy

Interventions

TRV130
Moxifloxacin
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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 Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

May 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Jan 9, 2015

First Submission Date that Met QC Criteria

Jan 16, 2015

First Posted Date

Jan 22, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2017

Last Update Posted Date

May 12, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part A	Experimental	Fixed sequence, open label	Drug: TRV130
Part B	Experimental	4 way cross over, double blind	Drug: TRV130 Drug: Moxifloxacin Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TRV130	Drug		Part A Part B
Moxifloxacin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part A - Number of Participants with Adverse Events as a Measure of Safety and Tolerability		Prior to dose through 4 hours
Part B - Change from baseline in QTc		Prior to dose through 24 hours

Secondary Outcomes

Measure	Description	Time Frame
Part B - Pharmacodynamics - QTc	Including QTc, heart rate, PR interval, QRS interval, uncorrected QT interval, ECG morphology and correlation between the QTcF change from baseline and plasma concentrations of TRV130.	Prior to dose through 24 hours
Part B - Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male and/or female subjects between the ages of 18 and 45 inclusive.
Women must be either a) post-menopausal; b) surgically sterile; c) of child-bearing potential and practicing contraception or remaining sexually inactive.
Men must be willing to abstain from sperm donation from the time of Screening through the Follow-up Visit and, if sexually active with a woman of child-bearing potential, must be protected by acceptable forms of effective contraception through the Follow-up Visit.

Exclusion Criteria:

Past or present diseases including, but not limited to, significant medical abnormalities including: psychiatric, neurologic, pulmonary, cardiac, gastrointestinal, genitourinary, renal, metabolic, endocrinologic or autoimmune disorders.
Has previously participated in another TRV130 clinical study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Franck Skobieranda	Trevena Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Baltimore	Maryland	21225	United States

Intervention Browse Module

MeSH Terms

ID	Term
C586842	((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine
D000077266	Moxifloxacin

Ancestor Terms

ID	Term
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines

Browse Leaves

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Browse Branches

Not provided