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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00713336 |
This Study compares two ZD4054 doses (10mg and 30mg) with a placebo and a positive control to look at ZD4054's effect on the ECG of Healthy Volunteer
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: ZD4054 Drug: Moxifloxacin Drug: ZD4054 Placebo Drug: Moxifloxacin placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Safety Study |
Official Title: | A Phase I, Double-Blind, Double-Dummy, Placebo-Controlled, Randomised, Four-Period Crossover Study to Assess the Effects of Single Oral Doses of ZD4054 (10mg and 30mg) on QTc Interval Compared to Placebo, Using AVELOX (Moxifloxacin) as a Positive Control, in Healthy Volunteers Aged 18 to 45 Years. |
Estimated Enrollment: | 40 |
Study Start Date: | June 2008 |
Study Completion Date: | November 2008 |
Arms | Assigned Interventions |
---|---|
1: Experimental
ZD4054 + Moxifloxacin placebo
|
Drug: ZD4054
ZD4054 10mg Tablet
Drug: Moxifloxacin placebo
1 capsule
Drug: ZD4054
30mg tablet
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2: Active Comparator
ZD4054 placebo + Moxifloxacin
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Drug: ZD4054
ZD4054 10mg Tablet
Drug: Moxifloxacin
400 mg capsule
Drug: ZD4054 Placebo
3 tablets
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3: Experimental
ZD4054 + ZD4054 placebo + Moxifloxacin placebo
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Drug: ZD4054
ZD4054 10mg Tablet
Drug: Moxifloxacin placebo
1 capsule
Drug: ZD4054 Placebo
2 tablets
Drug: ZD4054
10mg tablet
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4: Placebo Comparator
ZD4054 Placebo + Moxifloxacin placebo
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Drug: ZD4054
ZD4054 10mg Tablet
Drug: ZD4054 Placebo
3 tablets
Drug: Moxifloxacin placebo
1 capsule
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
Research Site | |
Macclesfield, United Kingdom |
Principal Investigator: | Raj Chetty, MD | Clinical Pharmacology UnitAlderley ParkAstraZenecaMacclesfieldSK10 4TG |
Responsible Party: | AstraZeneca Pharmaceuticals ( Dr Thomas Morris, Medical Science Director, AstraZeneca ) |
Study ID Numbers: | D4320C00017, ZD4054IL0017 |
Study First Received: | July 9, 2008 |
Last Updated: | February 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00713336 History of Changes |
Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
ZD4054 Healthy Volunteers QT interval |
Anti-Infective Agents Moxifloxacin Healthy |
Anti-Infective Agents Moxifloxacin Therapeutic Uses Pharmacologic Actions |