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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT02344303

Run by

Trevena Inc.

People needed

63

Starts

2014-12-01

Expected to finish

2015-10-01

Last updated by the study team

2017-05-12

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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