Last updated: 11/03/2018 12:14:14
QTc study of rosi XR in healthy volunteersRosi XR
GSK study ID
111802
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Withdrawn
Withdrawn
Trial overview
Official title: A study to evaluate the effect of extended release Rosiglitazone (RSG XR) on cardiac conduction as compared to placebo and a single oral dose of moxifloxacin
Trial description: This study is a randomised double blind, parallel group, and will evaluate the effects of repeat oral doses of RSG- XR for 21 days on the QTc interval compared to placebo in a population of healthy adult males and females.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Day 20 time-matched change from baseline in QTcI for RSG- XR 8mg and placebo
Timeframe: Day 20
Day 21 time-matched change from baseline in QTcI for RSG- XR 20mg, placebo and moxifloxacin 400mg
Timeframe: Day 21
Secondary outcomes:
Day 20 time-matched change from baseline in QTcF and QTcB for RSG XR 8mg and placebo.
Timeframe: Day 20
Day 21 time-matched change from baseline in QTcF and QTcB for RSG XR 20mg, placebo and moxifloxacin 400mg
Timeframe: Day 21
Tolerability of repeat doses of RSG- XR at 8 mg and a single oral dose of RSG- XR at 20 mg as assessed by 12-lead ECGs, vital signs, adverse events, and clinical laboratory tests.
Timeframe: 21 days
Interventions:
Drug: Rosi XR
Other: Placebo
Drug: Moxifloxacin
Enrollment:
0
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Alzheimer's Disease
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
June 2009 to September 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 45 years
Accepts healthy volunteers
Yes
- Healthy male and female volunteers aged between 18 and 45
- 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
- Cardiac conduction abnormalities
- Any history of myocardial infarction, syncope, or cardiac arrhythmias or a history of uncontrolled hypertension or unstable heart disease
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy male and female volunteers aged between 18 and 45
- 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:
- Cardiac conduction abnormalities
- 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
Trial location(s)
Location
GSK Investigational Site
Springfield, Missouri, United States, 65802
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Overland Park, Kansas, United States, 66211
Status
Will Be Recruiting
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Withdrawn
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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