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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

April 23, 2009
July 15, 2009
April 2009
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00887770 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study to Investigate the Potential for AZD5672 to Affect the Electrical Conduction Pathways in the Heart
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Rheumatoid Arthritis
  • Drug: AZD5672
    12 x 50mg tablet, oral, single dose
  • Drug: Moxifloxacin
    1 x 400mg capsule, oral, single dose
    Other Name: Avelox
  • Drug: placebo
    12 x matched to AZD5672 50 mg tablet
  • 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
  • Experimental: A
    600mg AZD5672 + Moxifloxacin placebo
    Interventions:
    • Drug: AZD5672
    • Drug: placebo
  • Experimental: B
    100mg AZD5672 + Moxifloxacin placebo
    Interventions:
    • Drug: AZD5672
    • Drug: placebo
    • Drug: placebo
  • Active Comparator: C
    AZD5672 placebo + Moxifloxacin 400mg
    Interventions:
    • Drug: Moxifloxacin
    • Drug: placebo
  • Placebo Comparator: D
    AZD5672 placebo + Moxifloxacin placebo
    Interventions:
    • Drug: placebo
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
July 2009
Not Provided

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
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00887770
D1710C00006, Eudract No. 2009-009940-22
No
MSD, AstraZeneca
AstraZeneca
Quintiles Limited
Study Director: Mark Layton AstraZeneca R&D, Alderley Park, UK
Principal Investigator: Darren Wilbraham Guys Drug Research Unit, Newcomen St, London
AstraZeneca
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP