A Study to Investigate the Effect of Single Dose of AZD6094 (600 mg) on Cardiac Repolarization in Healthy Volunteers
Status:
Completed
Trial end date:
2018-03-24
Target enrollment:
Participant gender:
Summary
This is a randomized, placebo-controlled, double-blind, 3-way crossover phase I study being
conducted on healthy volunteers to investigate the effect of single dose of AZD6094 (600 mg)
on cardiac repolarization under well-controlled conditions in accordance with the
International Council for Harmonization (ICH) E14 guidelines. An open-label Moxifloxacin (400
mg), a fluoroquinolone broad spectrum antibiotic will be used as a appositive control for the
time between the start of the Q wave and the end of the T wave (QT) prolongation in
accordance with ICH E14 guidelines, to establish assay sensitivity. The core study consists
of screening period, 3 treatment period (AZD6094, placebo and moxifloxacin; with a minimum
washout period of 14 days between each treatment period) and follow-up. The study drugs will
be administered orally. The study is planned to determine effect of AZD6094 at therapeutic
dose, safety and tolerability. This study provides adequate and well-controlled mechanisms to
deal with potential bias, facilitate identification of effects related to investigational
product (IMP) administration and tolerability issues.
Phase:
Phase 1
Details
Lead Sponsor:
AstraZeneca
Collaborator:
Parexel
Treatments:
Fluoroquinolones Moxifloxacin Norgestimate, ethinyl estradiol drug combination