Subcutaneous and Oral TRV250 in Healthy Adult Males and Females
Research type
Research Study
Full title
A Two Part, Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Oral TRV250 in Healthy Adult Males and Females
IRAS ID
221609
Contact name
Peter Dewland
Contact email
Sponsor organisation
Trevena Inc
Eudract number
2016-005200-26
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
This research study is being done by a Sponsor company called "Trevena Inc". The drug being studied is called TRV250. TRV250 is a new compound being developed with the potential to treat migraine attacks, the main purpose of this study is to assess the safety and tolerability of TRV250 as an injection given just under the skin and to look at how much of the study compound (TRV250) gets into the blood stream (Part A). The study is also going to look at TRV250 as an oral capsule with the same aims to assess the safety and tolerability and look how much gets into the blood stream (Part B).
Approximately 36 subjects (27 in Part A and 9 in Part B) healthy male and female subjects; 18 – 50 years of age inclusive will be recruited. Subjects taking part in Part A of this study will be split into 3 groups of 9 people. Each group will receive 2 doses of the study drug and one dose of placebo over 3 separate periods. After each dose, the study data will be reviewed by a safety committee before the dose is increased in the period, if deemed safe to do so. The starting dose in Part A will be 0.1mg.
This is the first time the study compound is being given to humans but it has previously been tested extensively in animals.
REC name
Wales REC 1
REC reference
17/WA/0007
Date of REC Opinion
20 Feb 2017
REC opinion
Further Information Favourable Opinion