Last updated: 11/04/2018 08:30:41

A study to compare the effect on heart rhythm of 3 days of GSK189075, placebo, or Moxifloxacin in healthy adults

GSK study ID
KG2107489
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Randomized, Double-blind, Placebo-Controlled, Cross-Over Trial to Investigate the Effect of GSK189075 on Cardiac Repolarization as Compared to Placebo and a Single Dose of Moxifloxacin in Healthy Adult Subjects
Trial description: This study assesses for change in heart rhythm of healthy volunteers taking GSK189075 for 3 days at a normal dose and a higher than normal dose compared to placebo or to a single dose of moxifloxacin. Treatments are GSK189075 500mg daily for three days plus moxifloxacin placebo on Day 3; GSK189075 4000mg daily for three days plus moxifloxacin placebo on Day 3; placebo tablets daily for three days plus moxifloxacin placebo on Day 3; placebo tablets daily for three days plus Moxifloxacin 400mg on Day 3. Volunteers are blindfolded during dosing. Each volunteer participates in all four treatment periods and will have received each dose combination at study end. Volunteers will stay at the research unit from the day before the first dose of study drug until the day after the last dose of study drug of each period. Safety measures include vital signs, laboratory tests on blood and urine, physical exams and ECGs. Volunteers wear a Holter monitor (a device that records heart rate and rhythm continuously) on days 1 and 3. Study drug levels are assessed by multiple blood draws, most of which occur on day 3.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Continuous holter monitor & ECG each treatment period:

Timeframe: Days 1 & 3

Secondary outcomes:

Drug plasma levels each treatment period:

Timeframe: Days 2 & 3

Safety ECG, labs, vital signs & adverse events:

Timeframe: each treatment period & follow-up

Interventions:
Drug: GSK189075
Enrollment:
78
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Type 2 Diabetes Mellitus
Product
remogliflozin etabonate
Collaborators
Not applicable
Study date(s)
September 2007 to February 2008
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 50 years
Accepts healthy volunteers
Yes
  • Healthy males or non-pregnant, non-lactating females between 18 and 50 years of age (inclusive), at the time of signing the informed consent form.
  • Body mass index (BMI) in the range of 19 to 32 (inclusive)
  • Cardiac conduction and repolarization abnormalities described in the protocol.
  • Any history of myocardial infarction, syncope, or cardiac arrhythmias or a history of uncontrolled hypertension or unstable heart disease.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
MADISON, Wisconsin, United States, 53704
Status
Study Complete

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2008-29-02

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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