Study to assess the effect of Selumetinib \[AZD6244; ARRY-142886\] \[Hyd-Sulfate\]), on QTc interval in healthy male volunteers.
A double-blind (Selumetinib \[AZD6244; ARRY-142886\] \[Hyd-Sulfate\]), Placebo-controlled, Open-Label (Moxifloxacin) Positive-controlled, Randomized, Three-period Crossover Study to Assess the Effects of Single Oral Dose of Selumetinib (75 mg) on QTc Interval Compared to Placebo, using AVELOX (Moxifloxacin) as a Positive Control, in Healthy Male Volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
54
Volunteers will receive 75 mg selumetinib oral dose (Treatment A)
Volunteers will receive 400 mg Moxifloxacin oral dose (Treatment B)
Volunteers will receive selumetinib placebo oral dose (Treatment C)
Research Site
Overland Park, Kansas, United States
Change From Baseline in QTcF
Change from baseline in QTcF at 30 minutes (msec)
Time frame: 30 min
Change From Baseline in QTcF
Change from baseline in QTcF at 1 hour (msec)
Time frame: 1 hour
Change From Baseline in QTcF
Change from baseline in QTcF at 1 hour 30 min (msec)
Time frame: 1 hour 30 min
Change From Baseline in QTcF
Change from baseline in QTcF at 2 hours (msec)
Time frame: 2 hours
Change From Baseline in QTcF
Change from baseline in QTcF at 3 hours (msec)
Time frame: 3 hours
Change From Baseline in QTcF
Change from baseline in QTcF at 4 hours (msec)
Time frame: 4 hours
Change From Baseline in QTcF
Change from baseline in QTcF at 6 hours (msec)
Time frame: 6 hours
Change From Baseline in QTcF
Change from baseline in QTcF at 8 hours (msec)
Time frame: 8 hours
Change From Baseline in QTcF
Change from baseline in QTcF at 12 hours (msec)
Time frame: 12 hours
Change From Baseline in QTcF
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Change from baseline in QTcF at 24 hours (msec)
Time frame: 24 hours