PK Interaction Study of IDN-6556 and Ciclosporin

• Research type

  Research Study

• Full title

  An Open-Label Pharmacokinetic Interaction Study of IDN-6556 and Ciclosporin in Healthy Volunteers

• IRAS ID

  112175

• Contact name

  Joseph Chiesa

• Sponsor organisation

  Conatus Pharmaceuticals

• Eudract number

  2012-003134-16

• ISRCTN Number

  N/A

• Research summary

  The main aim of the study is to see whether administration of ciclosporin affects the pharmacokinetics (blood levels over a time profile) of IDN-6556 and conversely to investigate the effects on pharmacokinetics of ciclosporin following administration of IDN-6556. To this aim, 15 healthy subjects will be enrolled following screening procedures and then given a single dose of IDN-6556 alone, followed by ciclosporin alone until blood levels are steady, then administer both ciclosporin and IDN-6556 together to assess whether the pharmacokinetic profile (blood levels over a time profile) of IDN-6566 is different when given alone or when given in the presence of ciclosporin in the blood. In a separate treatment period, followed by an adequate washout period, IDN-6556 will be administered for several days until steady levels are obtained in the blood stream. Ciclosporin will then be administered together with IDN-6556 to determine the effects on pharmacokinetics of ciclosporin. In addition, blood markers that determine how the IDN-6556 affects the body will be assessed to see whether ciclosporin has any effect on these.

• REC name

  North East - York Research Ethics Committee

• REC reference

  12/NE/0285

• Date of REC Opinion

  24 Aug 2012

• REC opinion

  Further Information Favourable Opinion