Effects of 150mg & 600mg AZD5672 compared to placebo & moxifloxacin

• Research type

  Research Study

• Full title

  A Single-centre, Double-blind, Double-dummy, Randomised, Placebo Controlled, Four Period Crossover Study to Assess the Effect of Single Oral Doses of AZD5672 (600 mg and 150 mg) on QT/QTc Interval, Compared to Placebo, using Moxifloxacin (Avelox) as a Positive Control, in Healthy Male Volunteers.

• IRAS ID

  19210

• Sponsor organisation

  AstraZeneca

• Eudract number

  2009-0110044-20

• Research summary

  AZD5672 is currently under development as a potential treatment for patients with Rheumatoid Arthritis. Multiple phase 1 clinical studies have been completed, and so far AZD5672 has been administered safely to a total of 193 healthy volunteers and 39 patients with rheumatoid arthritis. Currently, a phase 2 study involving 360 patients with Rheumatoid Arthritis is still ongoing. The current study is being performed to investigate the potential for AZD5672 to affect the electrical conduction pathways in the heart. AZD5672 will be compared against a drug (moxifloxacin - a licensed antibiotic) known to have a detectable but safe change on the electrical conduction of the heart. It is standard practice to conduct such studies before a drug is given a licence to be prescribed. Approximately 64 volunteers will take part in this study. However, we may extend this figure up to a maximum of 100 volunteers should the data from the study support this. The study will involve 4 admission periods each of 5 days (4 nights) and will be conducted at Guys Drug Research Unit (GDRU), London UK.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  09/H0804/20

• Date of REC Opinion

  8 Apr 2009

• REC opinion

  Further Information Favourable Opinion