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QTc Study of Rosi XR in Healthy Volunteers (Rosi XR)

Primary Purpose

Alzheimer's Disease

Status

Withdrawn

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Rosi XR

Placebo

Moxifloxacin

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring QTc, pharmacokinetics, rosiglitazone XR, cardiac conduction, healthy volunteers

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

GSK Investigational Site
GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Group 1

Group 3

Group 2

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

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.

Full Information

NCT ID

NCT00884533

First Posted

April 16, 2009

Last Updated

April 15, 2015

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00884533

Brief Title

QTc Study of Rosi XR in Healthy Volunteers

Acronym

Rosi XR

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Withdrawn

Why Stopped

The whole project was terminated

Study Start Date

June 2009 (undefined)

Primary Completion Date

August 2009 (Anticipated)

Study Completion Date

August 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

QTc, pharmacokinetics, rosiglitazone XR, cardiac conduction, healthy volunteers

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

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

Arm Title

Group 3

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Group 2

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Rosi XR

Intervention Description

Rosi XR

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Moxifloxacin

Intervention Description

400mg single dose

Primary Outcome Measure Information:

Title

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

Time Frame

Day 20

Title

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

Time Frame

Day 21

Secondary Outcome Measure Information:

Title

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

Time Frame

Day 20

Title

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

Time Frame

Day 21

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66211

Country

United States

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

SE1 1YR

Country

United Kingdom

12. IPD Sharing Statement

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QTc Study of Rosi XR in Healthy Volunteers

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