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

This study has been completed.
Sponsor:
Collaborator:
Quintiles Limited
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00887770
First received: April 23, 2009
Last updated: July 15, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: AZD5672
Drug: Moxifloxacin
Drug: placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Evaluate time-matched QTcF intervals of single dose AZD5672 600mg compared to placebo. [ Time Frame: Up to 24 hours postdose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate time-matched QTcF Intervals of single dose AZD5672 150mg compared to placebo. [ Time Frame: Up to 24 hours postdose ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 64
Study Start Date: April 2009
Study Completion Date: July 2009
Arms Assigned Interventions
Experimental: A
600mg AZD5672 + Moxifloxacin placebo
Drug: AZD5672
12 x 50mg tablet, oral, single dose
Drug: placebo
1 x matched to Moxifloxacin capsule
Experimental: B
100mg AZD5672 + Moxifloxacin placebo
Drug: AZD5672
3 x 50mg tablet, oral. single dose
Drug: placebo
9 x matched to AZD5672 50mg tablet
Drug: placebo
1 x matched to Moxifloxacin capsule
Active Comparator: C
AZD5672 placebo + Moxifloxacin 400mg
Drug: Moxifloxacin
1 x 400mg capsule, oral, single dose
Other Name: Avelox
Drug: placebo
12 x matched to AZD5672 50 mg tablet
Placebo Comparator: D
AZD5672 placebo + Moxifloxacin placebo
Drug: placebo
12 x matched to AZD5672 50 mg tablet
Drug: placebo
1 x matched to Moxifloxacin capsule

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00887770

Locations
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Quintiles Limited
Investigators
Study Director: Mark Layton AstraZeneca R&D, Alderley Park, UK
Principal Investigator: Darren Wilbraham Guys Drug Research Unit, Newcomen St, London
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00887770     History of Changes
Other Study ID Numbers: D1710C00006, Eudract No. 2009-009940-22
Study First Received: April 23, 2009
Last Updated: July 15, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
QTcF
Crossover
ICH E14
QT/QTc prolongation
Moxifloxacin
QT/QTc Interval

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014