Study evaluating the relative BA and food effect of BCX7353(QCL117961)
Research type
Research Study
Full title
A Phase 1, Single-Dose, 3-Period Crossover Study to Evaluate the Relative Bioavailability of Two BCX7353 Capsule Formulations and to Evaluate the Effect of Food on BCX7353 Pharmacokinetics in Healthy Subjects
IRAS ID
221478
Contact name
Amanda Mathis
Contact email
Sponsor organisation
BioCryst Pharmaceuticals, Inc.
Eudract number
2017-000049-27
Duration of Study in the UK
0 years, 3 months, 10 days
Research summary
The Sponsor is developing the study drug, BCX7353, for the potential treatment of Hereditary Angioedema (HAE). HAE is a potentially life threatening disease with symptoms that include swelling of the skin, throat, gut, genitals and extremities (hands and feet).
The study will look at how much of the study drug is taken into the body when given as two different capsules (drug in capsule and blend in capsule) and the effect of food on how the study drug is taken up, processed and removed from the body in healthy subjects.
The study will consist of up to 5 study periods split into 2 parts, involving up to 24 healthy male and female subjects. In Period A, B and C (Part 1) up to 24 subjects will receive a total dose of 350 mg drug in capsule following an overnight fast, 300 mg blend in capsule following an overnight fast and 300 mg blend in capsule following a high fat meal, on separate occasions. The results from Part 1 will determine whether the study will continue to Part 2. If occurring, in Period D and E (Part 2) up to approximately 18 subjects will receive a total dose of 300 mg blend in capsule following a moderate fat meal and 300 mg blend in capsule following a low fat meal, on separate occasions. The same subjects from Part 1 will participate in Part 2 if it is conducted.
REC name
Wales REC 1
REC reference
17/WA/0017
Date of REC Opinion
20 Feb 2017
REC opinion
Further Information Favourable Opinion