Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2009-06-30
2009-08-31
Brief Summary
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Detailed Description
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This study is a randomised double blind, parallel group, and will evaluate the effects of repeat oral doses of RSG- XR for 21 days (due to the long half-life of the main metabolite M10) on the QTc interval compared to placebo in a population of healthy adult males and females between 18 and 45 years of age. Moxifloxacin, a drug with well-quantified QTc prolongation, will be included as a positive control in order to validate the ability of the study to detect small changes in QTc.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1
Group 1 - placebo on Day -1, rosi XR 8mg from Days 1-20, rosi XR 20mg on Day 21
Rosi XR
Rosi XR
Placebo
Placebo
Group 3
Placebo on Day -1, Days 1-20 and Day 21
Placebo
Placebo
Group 2
Placebo for Day -1, placebo on Days 1-20 and moxifloxacin active comparator 400 mg on Day 21
Placebo
Placebo
Moxifloxacin
400mg single dose
Interventions
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Rosi XR
Rosi XR
Placebo
Placebo
Moxifloxacin
400mg single dose
Eligibility Criteria
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Inclusion Criteria
* Female of non child bearing potential or if of child bearing potential they must use adequate contraception for the duration of the study up until 14 days after the last dose
* Body weight greater than or equal to 45 kg and BMI within the range 19 - 32 inclusive
* Subjects must provide full written informed consent
Exclusion Criteria
* Any history of myocardial infarction, syncope, or cardiac arrhythmias or a history of uncontrolled hypertension or unstable heart disease
* Subjects with a systolic blood pressure outside the range of 90 to 150 mmHg or diastolic blood pressure outside the range of 50 to 100 mmHg
* Subjects with a personal or family history of QTc prolongation or unexplained cardiac arrest.
* Has a history of illicit drug use or alcohol abuse within the past year or a positive pre-study test for alcohol, cotinine, or drugs of abuse at Screening or prior to the start of dosing
* Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase values greater than 2.5 times the ULN, total bilirubin values \>1.5 times the upper limit of normal (ULN), or history of severe hepatobiliary disease (e.g. hepatitis B or C, or cirrhosis, Child-Pugh Class B/C)
* A positive test at Screening for Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV)
* Use of any agents that are known to inhibit or induce cytochrome CYP3A4 enzymes within 7 days prior to the first dose of study drug (including foods or supplements such as grapefruit-containing products, mustard greens, kale, kohlrabi, broccoli, collard greens, brussel sprouts, watercress, charbroiled meats or St. John's Wort
* Use of any prescription or non-prescription drugs, in particular drugs known to inhibit or induce CYP2C8, vitamins (exceptions may be considered on a case-by-case basis with the GSK medical monitor), herbal and dietary supplements within fourteen days prior to the first dose of study drug
* Lactating or pregnant females
18 Years
45 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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GSK
Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Overland Park, Kansas, United States
GSK Investigational Site
London, , United Kingdom
Countries
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Other Identifiers
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111802
Identifier Type: -
Identifier Source: org_study_id
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