A Phase 1 study to assess the effect of BCX7353 on healthy volunteers

• Research type

  Research Study

• Full title

  A PHASE 1 STUDY TO EVALUATE THE EFFECT OF BCX7353 ON THE SINGLE DOSE PHARMACOKINETICS OF THE P-GP SUBSTRATE DIGOXIN AND THE BCRP SUBSTRATE ROSUVASTATIN AND THE EFFECT OF THE P-GP INHIBITOR CYCLOSPORINE ON THE SINGLE DOSE PHARMACOKINETICS OF BCX7353

• IRAS ID

  218195

• Contact name

  Firas Almazedi

• Contact email

  Firas.Almazedi@covance.com

• Sponsor organisation

  BioCryst Pharmaceuticals, Inc.

• Eudract number

  2016-003915-37

• Duration of Study in the UK

  0 years, 2 months, 26 days

• Research summary

  BCX7353 (study drug) is being developed as a potential preventative medication in the management of Hereditary angioedema (HAE). HAE is a genetic condition that is characterized by recurrent episodes of swelling of the skin, throat, gut genitals, and extremities. This drug blocks a chemical molecule causing these reactions in man. There is currently no oral medication licensed in the EU for prevention of HAE attacks. All licensed medications are administered by injection.

  Two studies have already taken place in humans and showed that this study drug (BCX7353) was safe and well tolerated. This study will be a drug interaction study to see if BCX7353 has any effect on the amount of some other drugs, namely Digoxin, Rosuvastatin in the bloodstream when they are taken at the same time. The study will also assess whether a drug called Cyclosporine, has any effect on the level of the study drug in the bloodstream when they are taken together.

  The study will be performed using three cohorts. Participation in Cohorts 1-3 will last approximately 8-9 weeks, from the start of screening to follow-up. All of the medications will be taken orally.

  Subjects in cohort 1 will receive the following medication:
  Day 1: Digoxin 0.25 mg oral dose
  Day 11-18: BCX7353 350 mg oral dose
  Day 19: Digoxin 0.25 mg oral dose and BCX7353 350 mg oral dose
  Day 20-21: BCX7353 350 mg oral dose

  Subjects in cohort 2 will receive the following medications:
  Day 1: Rosuvastatin 10 mg oral dose
  Day 7-14: BCX7353 350 mg oral dose
  Day 15: Rosuvastatin 10 mg oral dose and BCX7353 350 mg oral dose
  Day 16: BCX7353 350 mg oral dose

  Subjects in cohort 3 will receive the following:
  Day 1: BCX7353 350 mg oral dose
  Day 14: single oral dose of Cyclosporine 600 mg and BCX7353 350 mg oral dose

• REC name

  North East - York Research Ethics Committee

• REC reference

  16/NE/0373

• Date of REC Opinion

  7 Dec 2016

• REC opinion

  Favourable Opinion