Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days (TQT)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00686179
First received: May 27, 2008
Last updated: September 24, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: AZD3480
Drug: Moxifloxacin
Drug: PLACEBO
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 [ Time Frame: 11 dECG measurements x 4 (4-way crossover) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • QTcX (therapeutic doses in comparison to placebo).PR-, QRS-, RR-intervals [ Time Frame: 11 dECG measurements x 4 (4-way crossover) ] [ Designated as safety issue: Yes ]
  • Plasma concentration (AUC, Cmax, tmax etc) [ Time Frame: 11 PK-measurements x 4 (4-way crossover) ] [ Designated as safety issue: Yes ]
  • Registration of AEs, blood pressure, ECG, clinical laboratory tests [ Time Frame: From enrolment to follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 75
Study Start Date: January 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Escalating doses of AZD3480 during 6 days
Drug: AZD3480
Capsule, oral, single dose, 6 days
Other Name: TC-1734-226
Experimental: 2
Repeated doses of AZD3480 during 6 days
Drug: AZD3480
Capsule, oral, single dose, 6 days
Other Name: TC-1734-226
Placebo Comparator: 3
Placebo during 6 days
Drug: PLACEBO
Capsule, oral, single dose
Active Comparator: 4
Placebo during 5 days, active day 6
Drug: Moxifloxacin
Capsule(encapsulated), oral, single dose
Other Name: Moxifloxacin

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participation in a previous study for genotyping for identification to be extensive or poor metaboliser (CYP2D6 enzyme)
  • Physically and mentally healthy male volunteers

Exclusion Criteria:

  • 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.)
  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: NCT00686179

Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Hans-Göran Hårdemark Clinical Neuroscience TA AstraZeneca R&D Södertälje, Sweden
  More Information

No publications provided

Responsible Party: Hans-Göran Hårdemark, MD, PhD, Medical Science Director, AZD3480, AstraZeneca R&D, Södertälje, Sweden
ClinicalTrials.gov Identifier: NCT00686179     History of Changes
Other Study ID Numbers: D3690C00004, EUdract NO 2007-004859-11
Study First Received: May 27, 2008
Last Updated: September 24, 2008
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:
TQT
ECG
QT
QTc
AZD3480
ECG(QTc effects)

Additional relevant MeSH terms:
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