- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01146886
Trial to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of BI135585 XX Administered as Tablet and as Solution in Healthy Volunteers
October 31, 2013 updated by: Boehringer Ingelheim
A Randomised, Double-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of 10 mg to 1200 mg of BI 135585 XX Administered as a Solution to Healthy Male Volunteers (Trial Part 1), Followed by an Open, Randomised, Single-dose, Intra-individual Bioavailability Comparison of 200 mg BI 135585 XX as Tablet and as Solution (Trial Part 2)
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)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Biberach, Germany
- 1283.1.1 Boehringer Ingelheim Investigational Site
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion criteria:
- healthy male volunteers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
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
|
Placebo Comparator: Placebo to BI 135585
1 single dose per subject as oral solution in Part 1
|
Part 1 - oral doses given to approximately 9 parallel groups of 8 subjects (6 on active and 2 on on placebo) on Day 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessment of tolerability by the investigator
Time Frame: up to 14 days post treatment
|
up to 14 days post treatment
|
Change from baseline in Physical examination (occurrence of findings)
Time Frame: up to 14 days post treatment
|
up to 14 days post treatment
|
Change from baseline in Vital signs (blood pressure [BP], pulse rate [PR], respiratory rate [RR])
Time Frame: up to 14 days post treatment
|
up to 14 days post treatment
|
Change from baseline in 12-lead ECG with special attention to QTc prolongation
Time Frame: up to 14 days post treatment
|
up to 14 days post treatment
|
Cardiopulmonary monitoring resulting in clinically relevant findings
Time Frame: up to 14 days post treatment
|
up to 14 days post treatment
|
Change from baseline in Clinical laboratory parameters including hormones of the HPA axis and thyroid gland
Time Frame: up to 14 days post treatment
|
up to 14 days post treatment
|
Number of patients with Adverse events (AE)
Time Frame: up to 14 days post treatment
|
up to 14 days post treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time Frame: up to 72 hours post treatment
|
up to 72 hours post treatment
|
(5α-THF + 5β-THF)/THE ratio as an indicator of 11β-HSD1 inhibition
Time Frame: up to 24h
|
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)
Time Frame: up to 72 hours post treatment
|
up to 72 hours post treatment
|
Cmax (maximum measured concentration of the analyte in plasma)
Time Frame: up to 72 hours post treatment
|
up to 72 hours post treatment
|
tmax (time from dosing to maximum measured concentration)
Time Frame: up to 72 hours post treatment
|
up to 72 hours post treatment
|
%AUCtz-∞ (percentage of the AUC0-∞ that was obtained by extrapolation)
Time Frame: up to 72 hours post treatment
|
up to 72 hours post treatment
|
λz (terminal rate constant in plasma)
Time Frame: up to 72 hours post treatment
|
up to 72 hours post treatment
|
t1/2 (terminal half-life of the analyte in plasma)
Time Frame: up to 72 hours post treatment
|
up to 72 hours post treatment
|
MRToral (mean residence time of the analyte in the body after oral administration)
Time Frame: up to 72 hours post treatment
|
up to 72 hours post treatment
|
CL/F (total/apparent clearance of the analyte in plasma after extravascular administration)
Time Frame: up to 72 hours post treatment
|
up to 72 hours post treatment
|
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time Frame: up to 72 hours post treatment
|
up to 72 hours post treatment
|
Aet1-t2 (amount of analyte eliminated in urine from timepoint t1 to timepoint t2) SRD part only
Time Frame: up to 72 hours post treatment
|
up to 72 hours post treatment
|
fet1-t2 (fraction of analyte eliminated in urine from timepoint t1 to timepoint t2) SRD part only
Time Frame: up to 72 hours post treatment
|
up to 72 hours post treatment
|
CLR,t1-t2 (renal clearance of the analyte from timepoint t1 to timepoint t2) SRD part only[
Time Frame: up to 72 hours post treatment
|
up to 72 hours post treatment
|
UFF/UFE ratio as an indicator of 11β-HSD2 inhibition
Time Frame: up to 24h
|
up to 24h
|
Total urinary corticosteroids (5α-THF + 5β-THF + THE + UFF + UFE) as an indicator of the activation of the HPA axis
Time Frame: up to 24h
|
up to 24h
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
June 14, 2010
First Submitted That Met QC Criteria
June 21, 2010
First Posted (Estimate)
June 22, 2010
Study Record Updates
Last Update Posted (Estimate)
November 1, 2013
Last Update Submitted That Met QC Criteria
October 31, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1283.1
- 2010-018856-28 (EudraCT Number: EudraCT)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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