A drug level and safety study of OC000459
Research type
Research Study
Full title
Evaluation of Two Tablet Formulations of OC000459 As Drug Product to Be Used in Efficacy Trials of OC000459: The Evaluation of Biocomparison of Single Doses in the Fasted and Fed States and of Dose Proportionality of One of These Formulations in Either The Fed or Fasted State.
IRAS ID
82131
Contact name
Salvatore Febbraro
Sponsor organisation
Oxagen Limited
Eudract number
2011-002152-14
ISRCTN Number
1
Research summary
OC000459 is being developed for the treatment of asthma and allergy. The study is split into 2 parts (Part A and B). In Part A we will be looking at how long it takes for OC000459 from 2 different tablets (formulations A and B), to be detected in the blood, how much can be detected, how long it can be detected for and whether this is affected by food. We will do this by giving OC000459 before breakfast, after a fried breakfast and after a normal breakfast. In Part B we will be looking at the effects of increasing doses of formulation A. OC000459 has been given to both healthy subjects and those with allergy and asthma. In previous clinical studies, OC000459 was found to be safe and well tolerated. This is an open-label (both subjects and researchers will know which treatment is being received), study in a total of 24 healthy volunteers. There will be 6 Treatment Periods in Part A and 4 Treatment Periods in Part B, each consisting of 3 overnight stays at Simbec and separated by a minimum of 7 days. The study will be conducted as 2 groups of 12 subjects.Blood samples will be collected for the measurement of OC000459 levels and safety screens. Other safety parameters will also be measured at pre-determined time-points during the study, these include blood pressure, pulse, body temperature and 12 lead ECG. Adverse events will be monitored throughout the study.
REC name
Wales REC 1
REC reference
11/WA/0155
Date of REC Opinion
27 Jun 2011
REC opinion
Further Information Favourable Opinion