Bioavailablity of 2 formulations of Avoralstat BCX4161-107
Research type
Research Study
Full title
A Study to Evaluate the Relative Bioavailability of Two Different Formulations of BCX4161 (Avoralstat) Compared to the Reference Soft Gelatin Capsule in Healthy Subjects
IRAS ID
191212
Contact name
Phil Collis PhD
Contact email
Sponsor organisation
BioCryst Pharmaceuticals, Inc.
Eudract number
2015-004159-26
Duration of Study in the UK
0 years, 5 months, 26 days
Research summary
The Sponsor is developing the study drug, Avoralstat, for the potential treatment of Hereditary Angioedema (HAE). HAE is a disorder passed from parent to child, in which recurrent attacks of swelling of the skin, throat, the digestive system, genitals and extremities (hands and feet).\n\nThe study will try to characterise how much study drug is in circulation in the body and how the body affects the study drug for two different tablet formulations compared to the reference soft gelatin capsule formulation of the study drug.\n\nThe study will consist of 2 parts involving up to 18 healthy male and female subjects in each part. Within each study part there will be 5 study periods. Part 1 will consist of the following periods:\nPeriod 1 Regimen A: 2 × avoralstat 250 mg tablets (tablet formulation A)\nPeriod 2 Regimen B: 5 × avoralstat 100 mg soft gelatin capsules (reference product)\nPeriod 3 Regimen C: X × avoralstat xxx mg tablets (tablet formulation A)\nPeriod 4 Regimen D: X × avoralstat xxx mg tablets (tablet formulation A)\nPeriod 5 Regimen E: X × avoralstat xxx mg tablets (tablet formulation A)\n\nPart 2 will contain the following regimens:\nPeriod 1 Regimen F: 2 × avoralstat 250 mg tablets (tablet formulation B)\nPeriod 2 Regimen B: 5 × avoralstat 100 mg soft gelatin capsules (reference product)\nPeriod 3 Regimen G: X × avoralstat xxx mg tablets (tablet formulation B)\nPeriod 4 Regimen H: X × avoralstat xxx mg tablets (tablet formulation B)\nPeriod 5 Regimen I: X × avoralstat xxx mg tablets (tablet formulation B)\n
REC name
HSC REC A
REC reference
15/NI/0228
Date of REC Opinion
6 Nov 2015
REC opinion
Further Information Favourable Opinion