This trial is conducted in Europe. The aim of this trial is to evaluate the effect of SNAC on cardiac repolarisation in healthy male subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
Novo Nordisk Investigational Site
Berlin, Germany
Number of treatment emergent adverse events
PART A
Time frame: From dosing (day 1) to follow-up (days 8-11)
The co-primary endpoints are Fridericia heart rate corrected QT interval (QTcF)
PART B
Time frame: At 10, 20, 30, 40, 50 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 8, and 12 hours
Maximum observed SNAC plasma concentration
PART A
Time frame: From 0 to 12 hours
Trial population-specific (accounted for individual subject levels) corrected QT interval (QTcP)
PART B
Time frame: At 10, 20, 30, 40, 50 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 8 and 12 hours
Area under the SNAC plasma concentration time curve
PART B
Time frame: From 0 to 12 hours
Maximum observed SNAC plasma concentration
PART B
Time frame: From 0 to 12 hours
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