BCX7353-102 Drug-Drug Interaction Study in Healthy Subjects(QCL117696)

• Research type

  Research Study

• Full title

  A Single Sequence, Open Label Drug-Drug Interation Study to Evaluate the Effect of BCX7353 On Cytochrome P450, 3A4, 2C9, 2C19 and 2D6 Enzyme Activity using Probe Substrates in Healthy Subjects.

• IRAS ID

  195297

• Contact name

  Amanda Mathis

• Contact email

  amathis@BIOCRYST.com

• Sponsor organisation

  BioCryst Pharmaceuticals, Inc.

• Eudract number

  2015-005381-27

• Clinicaltrials.gov Identifier

  NCT02819102

• Duration of Study in the UK

  0 years, 1 months, 19 days

• Research summary

  The Sponsor is developing the study drug, BCX7353, for the potential treatment of hereditary angioedema (HAE). This disorder causes episodes of swelling of the skin, throat, intestines, genitals and extremities, which can be painful, disfiguring and potentially life threatening.\n\nSometimes medicines can affect the drug levels and activity of other medications if they are mixed during their administration. The purpose of the study is to evaluate the effect of BCX7353 on a mixture of medications (midazolam, omeprazole, dextromethorphan and tolbutamide). \n\nThis study consists of one part involving up to 20 healthy subjects.\n

• REC name

  Wales REC 1

• REC reference

  16/WA/0009

• Date of REC Opinion

  4 Feb 2016

• REC opinion

  Favourable Opinion