Trial to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of BI135585 XX Administered as Tablet and as Solution in Healthy Volunteers
Phase 1
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: BI 135585Drug: Placebo to BI 135585
- Registration Number
- NCT01146886
- Lead Sponsor
- Boehringer Ingelheim
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 60
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 135585 BI 135585 1 single dose per subject as oral solution in Part 1, or 3 single doses per subject as oral solution and 2 different tablet formulations in Part 2 Placebo to BI 135585 Placebo to BI 135585 1 single dose per subject as oral solution in Part 1
- Primary Outcome Measures
Name Time Method Assessment of tolerability by the investigator 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 Change from baseline in Physical examination (occurrence of findings) 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
- Secondary Outcome Measures
Name Time Method tmax (time from dosing to maximum measured concentration) up to 72 hours post treatment 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 t1/2 (terminal half-life of the analyte in plasma) up to 72 hours post treatment Cmax (maximum measured concentration of the analyte in plasma) 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 %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 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 (5α-THF + 5β-THF)/THE ratio as an indicator of 11β-HSD1 inhibition up to 24h 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 MRToral (mean residence time of the analyte in the body after oral administration) 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 Total urinary corticosteroids (5α-THF + 5β-THF + THE + UFF + UFE) as an indicator of the activation of the HPA axis up to 24h
Trial Locations
- Locations (1)
1283.1.1 Boehringer Ingelheim Investigational Site
🇩🇪Biberach, Germany