FIH PK, tolerability and PD study of CNV2197944 in Healthy Volunteers

• Research type

  Research Study

• Full title

  A first time in human, randomised, placebo controlled study to investigate the pharmacokinetics, tolerability and pharmacodynamics of single ascending doses of CNV2197944 in healthy young volunteers

• IRAS ID

  70844

• Contact name

  John Lambert

• Sponsor organisation

  Convergence Pharmaceuticals Ltd

• Eudract number

  2010-023960-41

• Research summary

  CNV 2197944 is a state dependent CaV2.2 antagonist that is being developed for the treatment of chronic pain. This will be the first clinical investigation of CNV2197944. The study will investigate how safe the study drug is and how well it is tolerated after dosing, how the study drug is taken up, metabolised and distributed through the body and what effect the study drug has in man. The effect that food may have on the way that the study drug is taken up, metabolised and distributed through the body will also be looked at.The study is divided into two parts. In the first part, participants will be included as Cohort A. In the second part, participants will be included as Cohort B and Cohort C. Six subjects (4 on active drug and 2 on placebo at each dose) will be enrolled in cohort (A). Subjects will participate in a maximum of 3 ascending dose sessions. Eighteen subjects will be enrolled in cohorts B and C with alternate dosing between each cohort. Within each cohort, 9 subjects (7 active; 2 placebo) will participate in three ascending dose sessions. When a maximum dose has been identified, a session repeating the maximum tolerated dose in the alternate cohort may be performed. Then both cohorts will receive a lower dose following a high fat breakfast. The cohort that has not received this dose previously will be given it in the fasted state. This study will be performed at at the PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital, Watford Road, Harrow, HA1 3UJ.Blood will be collected for pharmacokinetic analysis and mechanical pain threshold will be investigated following the escalating doses for Cohorts B and C. Vital signs and ECG will be monitored. Pre- and post-dose haematology, biochemistry and urinalysis will be performed.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC01/30

• Date of REC Opinion

  1 Feb 2011

• REC opinion

  Further Information Favourable Opinion