Phase I study of HP-3070 in patients with schizophrenia
Research type
Research Study
Full title
Phase I study of HP-3070 in patients with schizophrenia
IRAS ID
152060
Contact name
Jorg Taubel
Contact email
Eudract number
2014-000806-36
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 (sublingually) but we want to test it as a transdermal patch known as ‘HP-3070 patch’ as this route will give a more continuous level of asenapine in the blood. Also Sycrest® tablets must be taken last if taken with other medications and must be taken twice daily and patients must not eat or drink beforehand. Such complicated instructions and restrictions can affect the patient’s compliance and therefore the management of symptoms. A once daily transdermal system should greatly improve the compliance of the patient and management of their symptoms by maintaining a steady state concentration in the blood by decreasing side-effects allowing more effective therapeutic doses to be administered.
In this study, patients who have been diagnosed with schizophrenia will attend our clinical unit for 3 main visits including 1 screening visit and 1 residential period over 30 days (29 nights) as well as a follow-up visit 7-10 days after dismissal. Hence, volunteers will be involved in the study for up to 90 days which will include a washout period. The main procedures involve taking blood samples to measure the levels of asenapine, regular checks of the skin areas where the patch is applied and other safety assessments to ensure volunteers well-being. We will also assess how well the asenapine is working using Positron Emission Tomography (PET) imaging to measure the binding of neurotransmitters such as dopamine to receptors in the brain.
The study is sponsored by Noven Pharmaceuticals and the data from this study will help to design further trials for bringing the HP-3070 patch to market
REC name
London - London Bridge Research Ethics Committee
REC reference
14/LO/0434
Date of REC Opinion
23 Apr 2014
REC opinion
Further Information Favourable Opinion