Safety, PK and PD of Rupatidine in Healthy Japanese Subjects SAD & MAD

• Research type

  Research Study

• Full title

  A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel group study to assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of oral Rupatadine in Healthy Japanese Subjects after Single and Multiple Ascending Doses

• IRAS ID

  119015

• Contact name

  Taubel Jorg

• Sponsor organisation

  J. Uriach y Compañia, S.A.

• Eudract number

  2012-004900-37

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  We are conducting a clinical study with a medication known as 'Rupatadine' at Richmond Pharmacology Ltd (RPL) clinical research unit. Rupatadine is a marketed drug developed by J. Uriach y CompaÇñia, S.A. which means it is approved for the treatment of allergic rhinitis (hayfever) and urticaria (skin rash or hives often caused by allergic reactions) in adults and adolescents. The aim of this study is to investigate the safety of Rupatadine and how well it is tolerated when given to 27 healthy Japanese volunteers as single and multiple oral doses. We will assess the levels of Rupatadine and its metabolites (break-down products) in the blood and urine (pharmacokinetics) as well as the effects of Rupatadine on cognitive function (pharmacodynamics) and ECG (Electrocardiogram which measures the electrical activity of the heart). The study incoporates adaptive study features regarding the anticipated doses and number of volunteers which can be used to gain the maximum information whilst ensuring safety of volunteers. The data from the study will be compared to data from non-Japanese volunteers to assess whether there are any ethnic differences. This will help us to determine suitable oral doses that can be given safely to Japanese patients and to obtain marketing approval in Japan. Other standard safety assessments will be conducted including laboratory tests (haematology, biochemistry, coagulation and urinalysis), vital signs and physical examinations. The study will take approximately 32 days to complete, including the time before the study to determine eligibility of volunteers to participate, the conduct of the study and the follow-up examinations at the end of the study. Volunteers will be required to attend a screening visit within 21 days before the first administration of Rupatadine or placebo. Participation requires 1 in-patient period of 10 days and 9 nights followed by 3 outpatient visits including a final follow-up.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  12/SC/0640

• Date of REC Opinion

  19 Nov 2012

• REC opinion

  Favourable Opinion