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Completed

NCT Number: NCT02344303

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

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

Completed

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Baltimore, Maryland, 21225, United States

About this study

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TRV130

Drug

moxifloxacin

Drug

Placebo

Drug

Primary outcomes

  1. Part A - Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: Prior to dose through 4 hours

  2. Part B - Change from baseline in QTc

    Time frame: Prior to dose through 24 hours

Secondary outcomes

  1. Part B - Pharmacodynamics - QTc

    Time frame: 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.

  2. Part B - Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: 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

  3. Part A & B - Pharmacokinetics - Cmax, tmax, AUC

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Trevena Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 22, 2015
Registry last updated
May 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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