Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days
TQT
A Double-Blind, Randomised, Multicentre, Placebo-Controlled, 4-Ways Crossover Study to Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days, Using Moxifloxacin as a Positive Control, in Healthy Male Volunteers, CYP2D6 Extensive and Poor Metabolisers.
2 other identifiers
interventional
75
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the effects on cardiac repolarisation of supratherapeutic doses of AZD3480 compared to placebo in healthy male volunteers, subgrouped as extensive metabolisers and poor metabolisers according to CYP2D6 metabolic capacity, using moxifloxacin as positive control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Jan 2008
Typical duration for phase_1 healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 27, 2008
CompletedFirst Posted
Study publicly available on registry
May 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedSeptember 25, 2008
September 1, 2008
7 months
May 27, 2008
September 24, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
QTcX interval (supratherapeutic doses in comparison to placebo).Subject-specific correction of QT, QTcF and QTcB (supportive outcome variables).Bazett QTcB=QT*RR-1/2Fridericia QTcF=QT'RR-1/3
11 dECG measurements x 4 (4-way crossover)
Secondary Outcomes (3)
QTcX (therapeutic doses in comparison to placebo).PR-, QRS-, RR-intervals
11 dECG measurements x 4 (4-way crossover)
Plasma concentration (AUC, Cmax, tmax etc)
11 PK-measurements x 4 (4-way crossover)
Registration of AEs, blood pressure, ECG, clinical laboratory tests
From enrolment to follow-up
Study Arms (4)
1
EXPERIMENTALEscalating doses of AZD3480 during 6 days
2
EXPERIMENTALRepeated doses of AZD3480 during 6 days
3
PLACEBO COMPARATORPlacebo during 6 days
4
ACTIVE COMPARATORPlacebo during 5 days, active day 6
Interventions
Eligibility Criteria
You may qualify if:
- Participation in a previous study for genotyping for identification to be extensive or poor metaboliser (CYP2D6 enzyme)
- Physically and mentally healthy male volunteers
You may not qualify if:
- History of clinically significant diseases or illness.
- Participation in another study the last 3 months
- Prescribed or non-prescribed medications from 3 weeks prior to first treatment day until follow-up except for paracetamol (max 1.5 g per day.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hans-Göran Hårdemark
Clinical Neuroscience TA AstraZeneca R&D Södertälje, Sweden
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 27, 2008
First Posted
May 29, 2008
Study Start
January 1, 2008
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
September 25, 2008
Record last verified: 2008-09