AZD6244 - BE or RBA of Variants of Selumetinib (AZD6244, Hyd-Sulfate)
Research type
Research Study
Full title
A Phase I, Single centre, Randomised, Open label, Crossover Study to Assess the Bioequivalence or Relative Bioavailability of Variants of Selumetinib (AZD6244, Hyd-Sulfate) Blue Capsules in Healthy Male Volunteers Aged 18 to 45 years
IRAS ID
168599
Contact name
Olufeyikemi Oluwayi
Contact email
Sponsor organisation
AstraZeneca R&D
Eudract number
2014-004241-27
Duration of Study in the UK
0 years, 3 months, 6 days
Research summary
AZD6244 (otherwise known as selumetinib) is currently being developed for cancer treatment. As of 31st July 2014, Selumetinib has already been given to approximately 2250 patients with cancer and 120 healthy volunteers in various studies.
This study is being carried out to test different variants of selumetinib capsules. We will compare three different variants of selumetinib capsules. This study will help us understand when compared to the reference capsule (treatment A), if one of the variant capsule has the equivalent blood concentration (treatment B), and in another variant, to measure its relative blood concentration (treatment C). This will help better understand the difference, if any, of these different Selumetinib capsules when tested in the laboratory compared to when taken by healthy volunteers.
A total of 48 volunteers aged 18 to 45 years will take part in this study.
The study will involve 5 visits to the study centre and it will take up to approximately 8 weeks to complete, including the screening visit and three admissions to the research unit (3 nights and 4 days long). All periods will be separated by a washout period of 7 to 10 days between doses of the study drug. A follow-up visit will occur 7 days after the last administration of the study drug.
Volunteers will be randomised (a process like flipping a coin) to the order with which they will receive the three different variants of Selumetinib (A, B or C). For example they could be randomised to receive it in any of these order: ABC, ACB, BAC, BCA, etc.
Blood samples for determination of the level of the study drug in the blood will be collected in each treatment period at various time-points pre-dose and post-dose.REC name
London - London Bridge Research Ethics Committee
REC reference
14/LO/2177
Date of REC Opinion
2 Feb 2015
REC opinion
Further Information Favourable Opinion