This monocenter trial is conducted to obtain first data on safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) after multiple ascending doses of BYK324677 in humans. In addition, the trial should provide preliminary information on a possible influence of sex, food intake, and posology (once or twice daily administration of BYK324677) to support the further planning of the drug development programme.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
capsules, administered orally
Nycomed Investigational site
Mannheim, Germany
Assessment of the safety/tolerability of multiple dosing of BYK324677 given once daily (SID) or twice daily (BID) in healthy volunteers.
Safety/tolerability variables: adverse events (AEs), vital signs (BP, pulse rate, body temperature), 12-lead ECG (PQ \[=PR\], QRS, QT, QTcF and QTcB intervals, heart rate), laboratory parameters including urinalysis.
Time frame: during screening, clinical part (treatment) and end-of-trial examination (up to 8 weeks)
Exploratory assessment of the pharmacokinetics (PK) of multiple dosing of BYK324677 (SID or BID) under steady state conditions in healthy volunteers.
Pharmacokinetic variables (e.g. AUC, Cmax, tmax, t1/2) of BYK324677 on Day 1 and Day 5 (single dose i.e. after first Investigational medicinal product (IMP) dose vs steady state) as well as on Day 4 and Day 5 (fed vs fasted, respectively).
Time frame: during Treatment Period 1 and Period 2 (up to 3 weeks)
Exploratory assessment of the pharmacodynamics (PD) of multiple dosing of BYK324677 (SID or BID) under steady state conditions in healthy volunteers.
Pharmacodynamic variables glucose, insulin, glucagon-like peptide 1 and glucagon on Day -1, Day 4 (fed) and Day 5 (fasted).
Time frame: during Treatment Period 1 and Period 2 (up to 3 weeks)
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