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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: Moxifloxacin; Drug: TRV130

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 Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21225

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	Adverse events reporting, clinical observations, 12- lead electrocardiograms, vital signs, respiratory rate, body temperature and safety laboratory tests	Prior to dose through Follow-Up Visit
Part A & B - Pharmacokinetics - Cmax, tmax, AUC	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)	Prior to dose through 24 hours

Collaborators and Investigators

• Sponsor: Trevena Inc.
• Investigators: Study Director: Franck Skobieranda, Trevena Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: January 9, 2015
• First Submitted That Met QC Criteria: January 16, 2015
• First Posted (Estimate): January 22, 2015

Study Record Updates

• Last Update Posted (Actual): May 12, 2017
• Last Update Submitted That Met QC Criteria: May 11, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin
• Other Study ID Numbers: CP130-1008