A Study to Investigate the Potential for AZD5672 to Affect the Electrical Conduction Pathways in the Heart

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: AZD5672; Drug: Moxifloxacin; Drug: placebo

• Registration Number: NCT00887770
• Lead Sponsor: AstraZeneca

Brief Summary

This 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-23
• Study First Submitted QC: 2009-04-23
• Study First Posted: 2009-04-24
• Status Verified: 2009-07
• Study Completion: 2009-07
• Last Update Submitted: 2009-07-15
• Last Update Posted: 2009-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

Inclusion Criteria

• Body Mass Index (BMI) between 18 and 30 kg/m2 and a minimum weight of 50kg.
• Non-smoker

Exclusion Criteria

• Marked QTc prolongation at baseline e.g. repeated demonstration of QTc interval >450ms or marked shortening of QTcF <350ms
• Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of the QTc Interval changes
• Use of concomitant medications that prolong QT/QTc interval

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	AZD5672	600mg AZD5672 + Moxifloxacin placebo
A	placebo	600mg AZD5672 + Moxifloxacin placebo
B	AZD5672	100mg AZD5672 + Moxifloxacin placebo
B	placebo	100mg AZD5672 + Moxifloxacin placebo
C	Moxifloxacin	AZD5672 placebo + Moxifloxacin 400mg
C	placebo	AZD5672 placebo + Moxifloxacin 400mg
D	placebo	AZD5672 placebo + Moxifloxacin placebo

Primary Outcome Measures

Name	Time	Method
Evaluate time-matched QTcF intervals of single dose AZD5672 600mg compared to placebo.	Up to 24 hours postdose

Secondary Outcome Measures

Name	Time	Method
Evaluate time-matched QTcF Intervals of single dose AZD5672 150mg compared to placebo.	Up to 24 hours postdose
To evaluate the change in time matched ECG parameters (QTcB, QTcX, RR, PR and QRS) of single dose AZD5672 600mg and 150mg compared to placebo	Up to 24 hours postdose
To further evaluate the safety and tolerability of single dose AZD5672 600mg and 150mg	Adverse events assessed throughout the whole study. Safety monitoring (BP, safety blood samples and ECG) conducted frequently throughout study and up to 72 hours post dose on treatment visits.

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom