QTc Study of Rosi XR in Healthy Volunteers

NCT00884533 | Withdrawn Phase 1

• 1 other identifier: 111802
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

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.

Conditions

Alzheimer's Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

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

  Day 20

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

  Day 21

Secondary Outcomes (3)

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

  Day 20

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

  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.

  21 days

Study Arms (3)

Group 1

EXPERIMENTAL

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

Drug: Rosi XR; Other: Placebo

Group 3

PLACEBO COMPARATOR

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

Other: Placebo

Group 2

ACTIVE COMPARATOR

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

Other: Placebo; Drug: Moxifloxacin

Interventions

Rosi XR DRUG

Rosi XR

Group 1

Placebo OTHER

Placebo

Group 1; Group 2; Group 3

Moxifloxacin DRUG

400mg single dose

Group 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Overland Park, Kansas, 66211, United States

Location

GSK Investigational Site

London, SE1 1YR, United Kingdom

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 16, 2009
• First Posted: April 20, 2009
• Study Start: June 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: April 17, 2015

Record last verified: 2015-04

Locations

US (1); GB (1)