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

Rheumatoid Arthritis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00887770
• Other study ID #: D1710C00006
• Secondary ID: Eudract No. 2009
• Status: Completed
• Phase: Phase 1
• First received: April 23, 2009
• Last updated: July 15, 2009
• Start date: April 2009
• Est. completion date: July 2009

Study information

• Verified date: July 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• AZD5672
12 x 50mg tablet, oral, single dose
• Moxifloxacin
1 x 400mg capsule, oral, single dose
• placebo
12 x matched to AZD5672 50 mg tablet
• AZD5672
3 x 50mg tablet, oral. single dose
• placebo
9 x matched to AZD5672 50mg tablet
• placebo
1 x matched to Moxifloxacin capsule

Locations

Country	Name	City	State
United Kingdom	Research Site	London

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Quintiles, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate time-matched QTcF intervals of single dose AZD5672 600mg compared to placebo.		Up to 24 hours postdose	Yes
Secondary	Evaluate time-matched QTcF Intervals of single dose AZD5672 150mg compared to placebo.		Up to 24 hours postdose	Yes
Secondary	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	Yes
Secondary	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.	Yes