Pharmacokinetic profile and patch adhesion of HP-3070-9.0

• Research type

  Research Study

• Full title

  A SINGLE CENTER, OPEN-LABEL, SINGLE-DOSE, FIVE-PERIOD CROSSOVER STUDY TO EVALUATE THE PHARMACOKINETIC PROFILE AND PATCH ADHESION OF HP-3070-9.0 PATCH (ASENAPINE TRANSDERMAL DRUG DELIVERY SYSTEM) FOLLOWING 24 HOUR APPLICATION AT FIVE DIFFERENT PATCH APPLICATION SITES IN JAPANESE AND CAUCASIAN HEALTHY VOLUNTEERS

• IRAS ID

  137667

• Eudract number

  2013-003567-63

• Research summary

  We are conducting a clinical research study with a medication known as asenapine which is already given to patients to treat schizophrenia and other psychotic disorders. Asenapine is currently administered as a tablet which is placed under the tongue but we want to test it via a patch known as ‘HP-3070-9.0 patch’ to see if this route will give a more continuous level of asenapine in the blood. The patients who use the patch may prefer to use it on different parts of the body so volunteers will receive the patch 5 times on different parts of the body (upper arm, upper chest, upper back, abdomen and hip area). We will then measure the levels of asenapine in the blood to see if it is different depending on the site of application and also compare the results between Caucasian and Japanese volunteers; as the data we obtain from this study will be one of the steps to enable the sponsors of the study to market HP-3070-9.0 in various countries including Japan.

  Volunteers will attend our clinical unit for approximately 6 visits including 1 screening visit and 5 residential periods over 7 days (6 nights) separated by a 10-day washout period in between periods as well as a telephone follow-up. Volunteers will be involved in the study for up to 95 days including the time when we determine who is suitable for taking part in the study and the conduct of the study. The main procedures will include taking blood samples to measure the levels of HP-3070-9.0 and regular checks of the skin areas where the patch is applied and other safety assessments to ensure volunteers well-being.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  13/LO/1192

• Date of REC Opinion

  19 Sep 2013

• REC opinion

  Further Information Favourable Opinion