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

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Trevena Inc.
• Treatments: Moxifloxacin

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.