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

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

      • Biberach, Germany
        • 1283.1.1 Boehringer Ingelheim Investigational Site

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.

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

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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