Tolerability and PK of prednisolone and dipyridamole - CRx-102-B04

• Research type

  Research Study

• Full title

  A Double-blind, Randomized, Placebo-controlled Study designed to Evaluate the Tolerability and Pharmacokinetics of Various Dosing Regimens of Prednisalone and Dipyridamole in Healthy Male and Female Subjects

• IRAS ID

  66191

• Contact name

  Stuart Mair

• Sponsor organisation

  Zalicus Inc

• Eudract number

  2010-023486-22

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Proof of concept studies have shown that dipyridamole given in combination with prednisolone can increase the beneficial effects of prednisolone without increasing side effects. Therefore it is hoped that these two drugs in combination will be effective in treating inflammatory diseases such as rheumatoid arthritis while reducing the dose of prednisolone required and hence reducing side effects. In previous studies evaluating the use of these drugs in combination headaches caused by dipyridamole have limited the tolerability of the treatment. These headaches are known to be less bothersome if the dose of dipyridamole is delivered slowly (as a modified release formulation) and also if the dose of dipyridamole is slowly increased over a number of days or weeks. In this study we aim to assess a number of regimens in which the dose of dipyridamole is slowly increased (titrated) in order to determine which regimen can reach an optimum therapeutic dose while effectively reducing the incidence of headache. Dipyridamole will be administered in divided doses over 6 hours in order to replicate the modified release formulation that is intended to eventually be used in clinical practice (a modified release formulation will deliver the dipyridamole more slowly than a conventional formulation, further reducing the incidence of headache).Fifty healthy male and female volunteers between 18 and 50 years of age who meet the inclusion/exclusion criteria will participate in the study.The study consists of one screening visit and one dosing/in-patient period, during which volunteers will be resident for either 23, 16, 12 or 9 nights (depending on the dose group).Each subject will receive prednisolone as 2 capsules on 2 occasions separated by 5 hours and dipyridamole will be given as a liquid on 9 separate occasions over 6 hours. The study will be conducted at 2 sites - Quotient Clinical Edinburgh and Nottingham.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC04/30

• Date of REC Opinion

  24 Nov 2010

• REC opinion

  Further Information Favourable Opinion