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Clinical Trial Details

Trial ID: L4244
Source ID: NCT01386541
Associated Drug: Byk324677
Title: Multiple Ascending Dose Trial of BYK324677 in Healthy Volunteers
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: BYK324677
Outcome Measures: Primary: 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., during screening, clinical part (treatment) and end-of-trial examination (up to 8 weeks) | Secondary: 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)., 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)., during Treatment Period 1 and Period 2 (up to 3 weeks)
Sponsor/Collaborators: Sponsor: Nycomed
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 36
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2011-06
Completion Date: 2011-11
Results First Posted:
Last Update Posted: 2012-05-07
Locations: Nycomed Investigational site, Mannheim, 68167, Germany
URL: https://clinicaltrials.gov/show/NCT01386541