Healthy
Conditions
Brief summary
Assess the electrocardiogram effects of TRV130 relative to placebo at therapeutic and supratherapeutic doses.
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
Interventions
Sponsors
Trevena Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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.
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Outcome results
None listed