Study of the Effects of TRV130, at Therapeutic and Supra Therapeutic Doses, on QTc Intervals
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 5/13/2017 |
| Start Date: | December 2014 |
| End Date: | October 2015 |
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
Assess the electrocardiogram effects of TRV130 relative to placebo at therapeutic and
supratherapeutic doses.
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
- Part B of the study will assess the effect of single dose TRV130 on QTc
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.
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