Study of the Effects of TRV130, at Therapeutic and Supra Therapeutic Doses, on QTc Intervals
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
1 other identifier
interventional
63
1 country
1
Brief Summary
Assess the electrocardiogram effects of TRV130 relative to placebo at therapeutic and supratherapeutic doses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Dec 2014
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 9, 2015
CompletedFirst Posted
Study publicly available on registry
January 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedMay 12, 2017
May 1, 2017
5 months
January 9, 2015
May 11, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Part A - Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Prior to dose through 4 hours
Part B - Change from baseline in QTc
Prior to dose through 24 hours
Secondary Outcomes (3)
Part B - Pharmacodynamics - QTc
Prior to dose through 24 hours
Part B - Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Prior to dose through Follow-Up Visit
Part A & B - Pharmacokinetics - Cmax, tmax, AUC
Prior to dose through 24 hours
Study Arms (2)
Part A
EXPERIMENTALFixed sequence, open label
Part B
EXPERIMENTAL4 way cross over, double blind
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Trevena Inc.lead
Study Sites (1)
Unknown Facility
Baltimore, Maryland, 21225, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Franck Skobieranda
Trevena Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2015
First Posted
January 22, 2015
Study Start
December 1, 2014
Primary Completion
May 1, 2015
Study Completion
October 1, 2015
Last Updated
May 12, 2017
Record last verified: 2017-05