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

Trevena Inc.63 enrolled

Overview

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

* 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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

TRV130DRUG

MoxifloxacinDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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

Time frame: Prior to dose through 4 hours

Part B - Change from baseline in QTc

Time frame: Prior to dose through 24 hours

Secondary Outcomes

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.

Time frame: 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

Time frame: 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)

Time frame: Prior to dose through 24 hours

Data from ClinicalTrials.gov

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