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

Study Overview
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Brief Summary
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Assess the electrocardiogram effects of TRV130 relative to placebo at therapeutic and supratherapeutic doses.

Detailed Description
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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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: TRV130
* Drug: Moxifloxacin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 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 |