Multiple dose study of CNV2197944 in adult and elderly volunteers

• Research type

  Research Study

• Full title

  A randomized, double-blind, sponsor-open, placebo controlled, parallel group study to investigate the pharmacokinetics and tolerability of multiple oral ascending doses of CNV2197944 in healthy male and healthy elderly male and female volunteers

• IRAS ID

  89646

• Contact name

  John Lambert

• Sponsor organisation

  Convergence Pharmaceuticals

• Eudract number

  2010-023961-23

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  CNV2197944 is being investigated as a novel treatment for chronic pain associated with osteoarthritis or neuropathy. The main purpose of the study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also investigate how the study drug is taken up, metabolised (chemically broken down in the body), distributed through the body and excreted. The study is divided into two parts: a part where healthy males will be included (aged 18 to 59 years) and a part where healthy elderly males and females will be included (aged 65 to 80 years). Separate groups of participants will be included in each part of the study. In the part with healthy males, participants in each of the groups will be given a higher dose, after the previous dose was assessed to be safe. The planned dose to be given in the part with healthy elderly males and females, will be the maximum dose that was well tolerated in the first part of the study. The planned duration of dosing will be 10 days or 15 days, depending on which group the participant's taking part, but may be extended so that dosing could be for up to 28 days. Within a group, participants will be randomised to receive either the study drug or placebo. This study will be performed at at the PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital, Watford Road, Harrow, HA1 3UJ. During the conduct of the study a number of tests will be performed. These will include assessments to monitor safety (like blood and urine tests, monitoring of vital signs, ECG assessments, physical examinations) and assessments to measure the amount of study drug in the body (blood and urine samples will be collected for this).

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  11/IE/0162

• Date of REC Opinion

  7 Nov 2011

• REC opinion

  Further Information Favourable Opinion