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Clinical Trial Details

Trial ID: L3031
Source ID: NCT01146886
Associated Drug: Placebo To Bi 135585
Title: Trial to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of BI135585 XX Administered as Tablet and as Solution in Healthy Volunteers
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Placebo to BI 135585|DRUG: BI 135585
Outcome Measures: Primary: Change from baseline in Physical examination (occurrence of findings), up to 14 days post treatment|Change from baseline in Vital signs (blood pressure [BP], pulse rate [PR], respiratory rate [RR]), up to 14 days post treatment|Change from baseline in 12-lead ECG with special attention to QTc prolongation, up to 14 days post treatment|Cardiopulmonary monitoring resulting in clinically relevant findings, up to 14 days post treatment|Change from baseline in Clinical laboratory parameters including hormones of the HPA axis and thyroid gland, up to 14 days post treatment|Number of patients with Adverse events (AE), up to 14 days post treatment|Assessment of tolerability by the investigator, up to 14 days post treatment | Secondary: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity), up to 72 hours post treatment|(5α-THF + 5β-THF)/THE ratio as an indicator of 11β-HSD1 inhibition, up to 24h|AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point), up to 72 hours post treatment|Cmax (maximum measured concentration of the analyte in plasma), up to 72 hours post treatment|tmax (time from dosing to maximum measured concentration), up to 72 hours post treatment|%AUCtz-∞ (percentage of the AUC0-∞ that was obtained by extrapolation), up to 72 hours post treatment|λz (terminal rate constant in plasma), up to 72 hours post treatment|t1/2 (terminal half-life of the analyte in plasma), up to 72 hours post treatment|MRToral (mean residence time of the analyte in the body after oral administration), up to 72 hours post treatment|CL/F (total/apparent clearance of the analyte in plasma after extravascular administration), up to 72 hours post treatment|Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose), up to 72 hours post treatment|Aet1-t2 (amount of analyte eliminated in urine from timepoint t1 to timepoint t2) SRD part only, up to 72 hours post treatment|fet1-t2 (fraction of analyte eliminated in urine from timepoint t1 to timepoint t2) SRD part only, up to 72 hours post treatment|CLR,t1-t2 (renal clearance of the analyte from timepoint t1 to timepoint t2) SRD part only[, up to 72 hours post treatment|UFF/UFE ratio as an indicator of 11β-HSD2 inhibition, up to 24h|Total urinary corticosteroids (5α-THF + 5β-THF + THE + UFF + UFE) as an indicator of the activation of the HPA axis, up to 24h
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: MALE
Age: ADULT
Phases: PHASE1
Enrollment: 60
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2010-06
Completion Date:
Results First Posted:
Last Update Posted: 2013-11-01
Locations: 1283.1.1 Boehringer Ingelheim Investigational Site, Biberach, Germany
URL: https://clinicaltrials.gov/show/NCT01146886