Pharmacokinetics of Oral Doses of CO-1686 Hydrobromide Salt(QBR114423)

• Research type

  Research Study

• Full title

  A Phase 1, 3 Part, Open Label Study to Assess the Pharmacokinetics of Single and Multiple Doses of Oral CO-1686 Hydrobromide Salt in Healthy Subjects

• IRAS ID

  124882

• Contact name

  Joanne Collier

• Sponsor organisation

  Clovis Oncology, Inc

• Eudract number

  2012-005355-17

• Research summary

  CO-1686 is being developed to treat a type of lung cancer (non-small cell lung cancer). The purpose of the study is to measure how well new forms of CO-1686 (the study drug) are taken up by the body, and how quickly the study drug is then removed from the body, compared to an existing form. The safety and tolerability of the study drug will also be assessed. Part 1 of this study will be the first time the new forms of CO-1686 have been dosed to humans.The study is divided into 3 parts. Part 1 will look at the blood levels and safety of single administrations of the old and new forms of CO-1686 in 12 healthy subjects. Part 2 will look at the blood levels and safety of single administrations of different amounts of a new form of CO-1686, and if food (eating) affects how the quickly body takes up the drug in 24 healthy subjects. The specific form of the study drug used in part 2 will have been decided by the information gathered in Part 1 of the study which will have already been completed at Quotient Clinical. Part 3 will look at the blood levels and safety of multiple administrations of different amounts of a new form of CO-1686, in 16 healthy subjects. The specific form of the study drug used in Part 3 will have been decided by the information gathered in Parts 1 and 2 of the study which will have already been completed at Quotient Clinical.

• REC name

  HSC REC B

• REC reference

  13/NI/0017

• Date of REC Opinion

  5 Mar 2013

• REC opinion

  Further Information Favourable Opinion