Rosi XR

WithdrawnPhase 1

QTc Study of Rosi XR in Healthy Volunteers

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

Lead sponsor

GlaxoSmithKline

Asset

Rosiglitazone

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 18-45

Primary endpoints

•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

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID111802

NCT IDNCT00884533

Timeline

Milestones

Study first posted2009-04-20estimated

Study start2009-06 (month precision)

Primary completion2009-08estimated (month precision)

Study completion2009-08estimated (month precision)

Last update posted2015-04-17estimated

Assets

Drug assets

Rosiglitazone

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

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

event count, event

Other (unclassified)

4 endpoints

Primary/protocol endpoint/low confidence

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

Time frame:Day 20

change from baseline, improvement

Primary/protocol endpoint/low confidence

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

Time frame:Day 21

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:Day 20

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:Day 21

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.