Safety, tolerability and PK of subcutaneous risperidone (QCL117436)

• Research type

  Research Study

• Full title

  A Two-Part Study, to Evaluate the Safety, Tolerability and\nPharmacokinetics of a Novel Risperidone Prolonged-Release\nSuspension for Subcutaneous Injection (TV-46000) (Part 1), and\nEvaluate the Influence of Manipulation of the Injection Site and\nthe Site of Administration on the Pharmacokinetics of the\nRisperidone (Part 2)

• IRAS ID

  163515

• Contact name

  Pavel Farkas

• Sponsor organisation

  PLIVA Hrvatska d.o.o (PLIVA Croatia Ltd.)

• Eudract number

  2015-001958-15

• Duration of Study in the UK

  0 years, 6 months, 9 days

• Research summary

  Risperidone is a drug that has been used for the treatment of schizophrenia (a long term mental disorder) since 1993. The Sponsor of this study is developing a novel long-acting formulation of risperidone for subcutaneous (under the skin) injection. The injection is designed to allow slow steady release of the study drug over time (from 1 to 3 months). There is a currently marketed long-acting injection which lasts for 2 weeks between doses. The rationale for developing a new formulation of the drug is that it will be more convenient for the patient as fewer visits will be required to a clinic, and will therefore improve patient compliance in taking the drug. \n\nThis Phase 1 healthy volunteer study will consist of 2 parts (6 treatment arms). Each healthy volunteer will participate in one treatment arm only. \n\nPart 1 of the study will look at the safety of a placebo subcutaneous injection. A placebo injection is a ‘dummy injection’ which contains everything in the true injection apart from the active ingredient (risperidone). Part 1 will also look at the safety of the novel long-acting risperidone injection formulation and how it is taken up and broken down by the body when given as an injection into the upper arm, at two different low dose levels.\n\nPart 2 will look at how safe the study drug is and how the study drug is taken up and broken down by the body after the site of injection (back of the upper arm) is rubbed after the injection is given and following an injection into a different part of the body (the abdomen).\n\nHealthy volunteers receiving the long-acting injectable formulation with risperidone will be pre-dosed with risperidone tablets for a week prior to receiving the injection, to ensure they can tolerate risperidone. \n

• REC name

  Wales REC 2

• REC reference

  15/WA/0272

• Date of REC Opinion

  20 Aug 2015

• REC opinion

  Favourable Opinion