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WithdrawnNCT00884533Rosi XRUpdated Apr 17, 2015

QTc Study of Rosi XR in Healthy Volunteers

A Phase 1 interventional study of Rosi XR and Placebo in Alzheimer's Disease, sponsored by GlaxoSmithKline. Withdrawn at 2 sites in 2 countries. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-17.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Why this study was withdrawn
The whole project was terminated
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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.

Read the detailed description

An extended release (XR) formulation of rosiglitazone maleate (RSG), a new formulation of rosiglitazone, is being investigated as a treatment for patients with mild to moderate Alzheimer's disease (AD).

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.

02

Conditions studied

  • Alzheimer's Disease

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Keywords

  • QTc
  • pharmacokinetics
  • rosiglitazone XR
  • cardiac conduction
  • healthy volunteers
03

In context

Alzheimer Disease

3,765 studies on the registry are indexed under Alzheimer Disease; 881 are open to participants now.

Browse Alzheimer Disease studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Group 1

    Group 1 - placebo on Day -1, rosi XR 8mg from Days 1-20, rosi XR 20mg on Day 21

    Drug: Rosi XR · Other: Placebo

  • Placebo comparator
    Group 3

    Placebo on Day -1, Days 1-20 and Day 21

    Other: Placebo

  • Active comparator
    Group 2

    Placebo for Day -1, placebo on Days 1-20 and moxifloxacin active comparator 400 mg on Day 21

    Other: Placebo · Drug: Moxifloxacin

Interventions

  • DrugRosi XR

    Rosi XR

  • OtherPlacebo

    Placebo

  • DrugMoxifloxacin

    400mg single dose

06

What researchers measure

Primary outcomes

  1. Day 20 time-matched change from baseline in QTcI for RSG- XR 8mg and placebo

    Time frame: Day 20

  2. Day 21 time-matched change from baseline in QTcI for RSG- XR 20mg, placebo and moxifloxacin 400mg

    Time frame: Day 21

Secondary outcomes

  1. Day 20 time-matched change from baseline in QTcF and QTcB for RSG XR 8mg and placebo.

    Time frame: Day 20

  2. Day 21 time-matched change from baseline in QTcF and QTcB for RSG XR 20mg, placebo and moxifloxacin 400mg

    Time frame: Day 21

  3. 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.

    Time frame: 21 days

07

Study locations

2 sites
  • GSK Investigational Site
    Overland Park, Kansas 66211, United States
  • GSK Investigational Site
    London, SE1 1YR, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00884533
Lead sponsor
GlaxoSmithKline
First posted
Apr 20, 2009
Start date
Jun 2009
Primary completion
Aug 2009 (estimated)
Completion
Aug 2009 (estimated)
Last update
Apr 17, 2015

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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