To demonstrate that BI 201335 does not prolong the QT interval more than placebo. To assess the tolerability of 1200 mg of BI 201335 as single dose in female subjects (double-blind, randomised, placebo-controlled) before inclusion of female subjects in the cross-over part of the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
QTcI interval (QT interval individually corrected for heart rate)
Time frame: pre-dose and 3 to 8 hours
The mean value of QTcI changes from baseline between 2 h and 24 h after dosing
Time frame: Pre dose and 2 to 24 hours post dosing
The change from mean baseline of the QTcI at any point in time between 2 h and 24 h after dosing
Time frame: Pre dose and 2 to 24 hours post dosing
The time-matched changes versus placebo in QTcI at any point in time between 2 h and 24 h after dosing
Time frame: Pre dose and 2 to 24 hours post dosing
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