Absorption, Metabolism and Excretion Study of BCX4161 (QBR116225)
Research type
Research Study
Full title
A Phase 1 Study to Evaluate the Absorption, Metabolism and Excretion of BCX4161 Following Administration of a Single, Oral Dose of [14C]-Radiolabeled BCX4161 to Healthy Male Subjects
IRAS ID
159045
Contact name
Pui Man Leung
Contact email
Sponsor organisation
BioCryst Pharmaceuticals, Inc.
Eudract number
2013-005377-49
Research summary
BCX4161 is being developed by BioCryst Pharmaceuticals Inc. for the treatment of hereditary angioedema (HAE) which is a potentially life threatening disease.
The purpose of the study is to measure how radiolabelled BCX4161 is taken up, broken down and removed from the body when given orally (by mouth) as capsules containing 14C-BCX4161 combined with un-labelled BCX4161. Blood, urine, faecal and expired air samples will be collected at specific times throughout the study.
The study will involve approximately 7 healthy male subjects. Subjects will receive a single 400 mg dose of oral capsules (4 x 100mg) containing a mixture of [14C]-BCX4161 and unlabelled BCX4161.
REC name
Wales REC 2
REC reference
14/WA/1060
Date of REC Opinion
18 Jul 2014
REC opinion
Favourable Opinion