Investigation of ADC3680B in healthy male and female volunteers.

• Research type

  Research Study

• Full title

  An Open-label, Study to Evaluate the Effects of Gender on the Pharmacokinetics, Safety and Tolerability of a Single Dose of ADC3680B Administered Orally to Healthy Male and Female Volunteers

• IRAS ID

  76444

• Contact name

  Salvatore Febbraro

• Sponsor organisation

  Pulmagen Therapeutics LLP

• Eudract number

  2011-001072-20

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  A new drug called ADC3680B is being developed for the treatment of both asthma and allergic rhinitis (an allergic reaction that can cause cold-like symptoms, such as sneezing, itchiness and a blocked or runny nose i.e. Hayfever). ADC3680B works by acting on cells in the blood which are involved in allergic reactions and may help ease or stop them from occurring. This study is intended to evaluate whether there are any gender differences in the pharmacokinetics, safety and tolerability of ADC3680B, when administered as a single dose. The study will be conducted in 16 (8 male and 8 female) healthy volunteers. Volunteers will need to attend Simbec Research Ltd on 3 occasions; once for a screening visit, once for the treatment period and once for the study follow-up visit. The treatment period will involve staying in Simbec from the afternoon of Day -1 (the day before dosing) until the morning of Day 3 (including 3 overnight stays) where subjects will receive a single dose of ADC3680B (25 mg) on the morning of Day 1. The safety of trial participants will be monitored by qualified and appropriately trained clinical staff throughout the study, and subjects will not be discharged from the study until they have satisfied the research physician that they are fit and well to do so.

• REC name

  Wales REC 1

• REC reference

  11/WA/0068

• Date of REC Opinion

  20 Apr 2011

• REC opinion

  Further Information Favourable Opinion