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NCT Number: NCT00887770

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD5672

Drug

12 x 50mg tablet, oral, single dose

moxifloxacin

Drug

1 x 400mg capsule, oral, single dose

Other names: Avelox

Placebo

Drug

12 x matched to AZD5672 50 mg tablet

Primary outcomes

  1. Evaluate time-matched QTcF intervals of single dose AZD5672 600mg compared to placebo.

    Time frame: Up to 24 hours postdose

Secondary outcomes

  1. Evaluate time-matched QTcF Intervals of single dose AZD5672 150mg compared to placebo.

    Time frame: Up to 24 hours postdose

  2. 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

    Time frame: Up to 24 hours postdose

  3. To further evaluate the safety and tolerability of single dose AZD5672 600mg and 150mg

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Quintiles, Inc.

Registry information

Official study 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

Important dates

Study start
2009
Study completion
2009
First posted
Apr 24, 2009
Registry last updated
Jul 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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