Cariprazine: comparison of slow- and immediate-release forms, ver A
Research type
Research Study
Full title
A Single-Dose Study to Evaluate the Pharmacokinetic, Safety, Tolerability Profile and the Effects of Food on the Pharmacokinetics of Different Formulations of Cariprazine in Healthy Male Subjects. HMR code: 13-019
IRAS ID
144708
Contact name
Frans van den Berg
Contact email
Sponsor organisation
GEDEON RICHTER PLC
Eudract number
2013-004925-99
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
Research summary
Cariprazine (the study medicine) is a potential new medicine for treating mental illnesses, such as schizophrenia, mania and depression. It’s different from existing. treatments (antipsychotics) in that it mainly acts at specific sites in the brain called dopamine D3 receptors. Cariprazine was very effective and well tolerated in clinical trials in patients, and is close to being made available for doctors to prescribe.
We’re doing this study to compare blood levels and side effects of cariprazine when it’s taken as one of two ‘slow-release’ tablets, or as an ‘immediate-release’ capsule. We’ll also find out if food affects the absorption of cariprazine into the bloodstream after a ‘slow-release’ tablet.
We’re doing the study in up to 200 healthy Caucasian men, aged 18–55. The study is in 2 parts.
* Part 1 – 120 participants will take a single dose of Cariprazine on an empty stomach. Each participant will take one of the study treatments (one of the two ‘slow-release’ tablets or the ‘immediate release’ capsule).
* Part 2 – up to 80 participants will take a single dose of a ‘slow-release’ tablet after a high-fat breakfast.Participants will take up to 8 weeks to finish the study. They’ll make 7 outpatient visits, and stay on the ward for 3 nights.
A pharmaceutical company Gedeon Richter Plc, is funding the study.
The study will take place at one centre in London.
REC name
London - Harrow Research Ethics Committee
REC reference
13/LO/1861
Date of REC Opinion
13 Dec 2013
REC opinion
Favourable Opinion