Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00686179

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 I

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:

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride Ispronicline

U.S. FDA Resources

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

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-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined

Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012