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

Launched by TREVENA INC. · Jan 16, 2015

Keywords

ClinConnect Summary

* 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

Gender

ALL

Eligibility criteria

• 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.