Safety and PK of BCX4161 in Healthy Volunteers (QBR115217)

• Research type

  Research Study

• Full title

  A Phase 1, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, pharmacokinetics and activity of BCX4161 in healthy subjects.

• IRAS ID

  124445

• Contact name

  Joanne Collier

• Sponsor organisation

  Biocryst Pharmaceuticals Inc

• Eudract number

  2013-000032-10

• ISRCTN Number

  to be registered

• Research summary

  The Sponsor is developing the study drug, BCX4161, for the potential treatment of hereditary angioedema which is a potentially life threatening disease. Symptoms of HAE include swelling of the skin, throat, gut, genitals and extremities (such as hands and feet).This study has been designed to look at the safety of BCX4161 (study drug), how the body tolerates the drug and how the drug is taken up by the body when administered at different doses. There are two parts to this study. In Part 1, there will be 5 cohorts, each consisting of 8 subjects. In each cohort, 6 subjects will receive a dose of the study drug, and two will receive a matching placebo. The dose of the study drug will range from 50 mg for subjects enrolled in Cohort 1 to 1000 mg for subjects enrolled in Cohort 5. Subjects in cohorts 1, 2, 3 and 5 will receive a single dose of the study drug, and those in Cohort 4 will receive two doses in order to examine food effect. Additional subjects may be recruited into Cohort 4 if the variability between'subjects is found to be high. In Part 2 of the study, there will be 12 subjects in 4 cohorts. In each Cohort, 10 subjects will receive the study drug and 2 will receive a matching placebo every day for 7 days. The doses given to each cohort will be selected based on the safety and pharmacokinetic data generated from Part 1 of the study. One Cohort in Part 2 of the study may have 20 subjects recruited if variability between'subjects is found to be high.

• REC name

  Wales REC 1

• REC reference

  13/WA/0028

• Date of REC Opinion

  27 Feb 2013

• REC opinion

  Further Information Favourable Opinion