PK study of KVD824 MR tablet formulations (QSC203521)
Research type
Research Study
Full title
A Multiple Part, Phase 1 Crossover Study in Healthy Subjects to Evaluate the Pharmacokinetic (PK) Profile of KVD824 Following Single and Multiple Doses of Novel KVD824 Modified Release (MR) Formulations Compared to a Reference KVD824 Immediate Release (IR) Formulation
IRAS ID
279137
Contact name
Matthew Iverson
Contact email
Sponsor organisation
KalVista Pharmaceuticals Ltd.
Eudract number
2020-000461-16
Duration of Study in the UK
0 years, 6 months, 4 days
Research summary
The Sponsor is developing the test medicine, KVD824, for the potential oral treatment of hereditary angioedema (HAE). HAE is a disorder defined by recurring incidents of severe swelling. The most common areas that develop swelling are the limbs, face, intestines and airways. HAE is caused by a genetic mutation rather than an allergy, which causes most cases of angioedema. This mutation leads to excessive activation of a specific enzyme, plasma kallikrein.\n \nThe study will try to identify how the test medicine is taken up by the body (pharmacokinetics), the level of test medicine in the blood following oral dosing (relative bioavailability), and try to provide additional safety and tolerability information for the test medicine. These will be evaluated in the fed and fasted state to examine the food effect. \n\nThe study will consist of three parts involving healthy male and female volunteers. In Part 1, volunteers will receive single oral doses of the test medicine across up to six treatment periods. There will be washout periods of at least seven days between periods. \n\nPart 2 is optional. If utilised, volunteers will receive single oral doses of the test medicine across two treatment periods, in the fed or fasted state. \n\nIn Part 3, volunteers in three cohorts will receive twice daily doses of the test medicine or placebo for 14 days. \n\nFor each study Part there will be a follow-up visit five to seven days post-final dose, to check the wellbeing of the volunteers. \n
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
20/SC/0157
Date of REC Opinion
14 May 2020
REC opinion
Further Information Favourable Opinion