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

Sponsor

Trevena Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02344303

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: TRV130 Drug: Moxifloxacin Drug: Placebo	Phase 1

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

Study Design

Study Type:

Interventional

Actual Enrollment :

63 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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

Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A Fixed sequence, open label	Drug: TRV130
Experimental: Part B 4 way cross over, double blind	Drug: TRV130 Drug: Moxifloxacin Drug: Placebo

Arm

Intervention/Treatment

Experimental: Part A

Fixed sequence, open label

Drug: TRV130

Experimental: Part B

4 way cross over, double blind

Drug: TRV130

Drug: Moxifloxacin

Drug: Placebo

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Part B - Pharmacodynamics - QTc [Prior to dose through 24 hours]
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.
Part B - Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Prior to dose through Follow-Up Visit]
Adverse events reporting, clinical observations, 12- lead electrocardiograms, vital signs, respiratory rate, body temperature and safety laboratory tests
Part A & B - Pharmacokinetics - Cmax, tmax, AUC [Prior to dose through 24 hours]
Parameters will include (but not limited to): Cmax, tmax, AUC0-τ, z: (apparent terminal rate constant calculated from the regression analysis (slope) of the log-transformed measured concentrations on the terminal phase of the time)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Baltimore	Maryland	United States	21225

Sponsors and Collaborators

Trevena Inc.

Investigators

Study Director: Franck Skobieranda, Trevena Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Trevena Inc.

ClinicalTrials.gov Identifier:

NCT02344303

Other Study ID Numbers:

CP130-1008

First Posted:

Jan 22, 2015

Last Update Posted:

May 12, 2017

Last Verified:

May 1, 2017

Additional relevant MeSH terms:

Moxifloxacin

Study Results

No Results Posted as of May 12, 2017