Bioavailability of ABT-450 and ABT-267 with Ritonavir (QBR116253)

• Research type

  Research Study

• Full title

  A Phase I, Open-Label, Single Centre Study Designed to Determine the Absolute Bioavailability of ABT-450 (150 mg) and ABT-267 (25 mg) when Administered as an Oral Co-Formulated Product with Ritonavir (100 mg), ABT 450/r/ABT 267, to Healthy Adult Subjects

• IRAS ID

  140436

• Contact name

  Pui Leung

• Contact email

  pui.leung@quotientbioresearch.com

• Sponsor organisation

  AbbVie Deutschland GmbH & Co KG

• Eudract number

  2013-003685-14

• Clinicaltrials.gov Identifier

  NCT02052362

• Research summary

  \nThe Sponsor is developing the study drugs, ABT-450/ritonavir and ABT-267, as the potential treatment of Hepatitis C. \nThe purpose of the study is to assess how much ABT-450 and ABT-267 is absorbed by the body when given as an oral tablet relative to when the drug is given intravenously (i.e. injected into a vein). The study will consist of 1 study period involving up to 16 healthy male and female subjects who will be assigned to 2 independent groups. Subjects in Group 1 will receive an oral dose of 150 mg ABT-450, 25 mg ABT-267 and 100 mg ritonavir and a dose intravenously. Subjects in Group 2 will receive an oral dose of 150 mg ABT-450, 25 mg ABT-267 and 100 mg ritonavir and a dose intravenously.\n\n

• REC name

  Wales REC 2

• REC reference

  13/WA/0348

• Date of REC Opinion

  15 Nov 2013

• REC opinion

  Favourable Opinion