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

Trevena

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: TRV130; Drug: Placebo; Drug: Moxifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02344303

CP130-1008

Details and patient eligibility

About

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

Full 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

Enrollment: 63 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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63 participants in 2 patient groups

Part A

Experimental group

Description:

Fixed sequence, open label

Treatment:

Drug: TRV130

Part B

Experimental group

Description:

4 way cross over, double blind

Treatment:

Drug: Moxifloxacin

Drug: TRV130

Drug: Placebo