A Study to Compare the Effect on Heart Rhythm of 3 Days of GSK189075, Placebo, or Moxifloxacin in Healthy Adults
Status:
Completed
Trial end date:
2008-02-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Moxifloxacin Norgestimate, ethinyl estradiol drug combination