Multiple Ascending Dose Trial of BYK324677 in Healthy Volunteers
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 Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Investigation of Safety/Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Doses of BYK324677 in Healthy Volunteers. A Monocentre, Placebo-controlled, Cross-over, Double-blind, Randomised Trial|
- Assessment of the safety/tolerability of multiple dosing of BYK324677 given once daily (SID) or twice daily (BID) in healthy volunteers. [ Time Frame: during screening, clinical part (treatment) and end-of-trial examination (up to 8 weeks) ] [ Designated as safety issue: No ]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.
- Exploratory assessment of the pharmacokinetics (PK) of multiple dosing of BYK324677 (SID or BID) under steady state conditions in healthy volunteers. [ Time Frame: during Treatment Period 1 and Period 2 (up to 3 weeks) ] [ Designated as safety issue: No ]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).
- Exploratory assessment of the pharmacodynamics (PD) of multiple dosing of BYK324677 (SID or BID) under steady state conditions in healthy volunteers. [ Time Frame: during Treatment Period 1 and Period 2 (up to 3 weeks) ] [ Designated as safety issue: No ]Pharmacodynamic variables glucose, insulin, glucagon-like peptide 1 and glucagon on Day -1, Day 4 (fed) and Day 5 (fasted).
|Study Start Date:||June 2011|
|Study Completion Date:||November 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Active Comparator: BYK324677
In each dose group 12 subjects (8 subjects BYK324677, 4 subjects placebo) are planned.
Within each dose group, the subjects will be randomised to either BYK324677 or placebo at a ratio of 2:1.
Within each verum group, the subjects will be randomised to one of the 2 treatment sequences (BID/SID or SID/BID, ratio 1:1) and treated in a cross-over manner.
capsules, administered orally
|Placebo Comparator: Placebo||
capsules, administered orally
Please refer to this study by its ClinicalTrials.gov identifier: NCT01386541
|Nycomed Investigational site|
|Mannheim, Germany, 68167|