Diabetes Mellitus, Type 2
Conditions
Brief summary
The purpose of the study is to investigate the safety, tolerability, pharmacokinetics incl. dose proportionality, and pharmacodynamics of BI 135585 XX (Part 1), as well as the relative bioavailability of two different immediate release tablet formulations versus oral solution (Part 2)
Interventions
Part 1 - oral doses given to approximately 9 parallel groups of 8 subjects (6 on active and 2 on on placebo) on Day 1
DRUGBI 135585
Part 1 - oral doses given to approximately 9 parallel groups of 8 subjects (6 on active and 2 on placebo) on Day 1; Part 2 - oral doses given to 12 subjects on Day 1
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
\- healthy male volunteers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| Aet1-t2 (amount of analyte eliminated in urine from timepoint t1 to timepoint t2) SRD part only | 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 |
Countries
Germany
Outcome results
None listed