Trial to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of BI135585 XX Administered as Tablet and as Solution in Healthy Volunteers

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01146886
• Other study ID #: 1283.1
• Secondary ID: 2010-018856-28
• Status: Completed
• Phase: Phase 1
• First received: June 14, 2010
• Last updated: October 31, 2013
• Start date: June 2010

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion criteria:

• healthy male volunteers

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Placebo to BI 135585
Part 1 - oral doses given to approximately 9 parallel groups of 8 subjects (6 on active and 2 on on placebo) on Day 1
• BI 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

Locations

Country	Name	City	State
Germany	1283.1.1 Boehringer Ingelheim Investigational Site	Biberach

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Physical examination (occurrence of findings)		up to 14 days post treatment	No
Primary	Change from baseline in Vital signs (blood pressure [BP], pulse rate [PR], respiratory rate [RR])		up to 14 days post treatment	No
Primary	Change from baseline in 12-lead ECG with special attention to QTc prolongation		up to 14 days post treatment	No
Primary	Cardiopulmonary monitoring resulting in clinically relevant findings		up to 14 days post treatment	No
Primary	Change from baseline in Clinical laboratory parameters including hormones of the HPA axis and thyroid gland		up to 14 days post treatment	No
Primary	Number of patients with Adverse events (AE)		up to 14 days post treatment	No
Primary	Assessment of tolerability by the investigator		up to 14 days post treatment	No
Secondary	AUC0-8 (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	No
Secondary	(5a-THF + 5ß-THF)/THE ratio as an indicator of 11ß-HSD1 inhibition		up to 24h	No
Secondary	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	No
Secondary	Cmax (maximum measured concentration of the analyte in plasma)		up to 72 hours post treatment	No
Secondary	tmax (time from dosing to maximum measured concentration)		up to 72 hours post treatment	No
Secondary	%AUCtz-8 (percentage of the AUC0-8 that was obtained by extrapolation)		up to 72 hours post treatment	No
Secondary	?z (terminal rate constant in plasma)		up to 72 hours post treatment	No
Secondary	t1/2 (terminal half-life of the analyte in plasma)		up to 72 hours post treatment	No
Secondary	MRToral (mean residence time of the analyte in the body after oral administration)		up to 72 hours post treatment	No
Secondary	CL/F (total/apparent clearance of the analyte in plasma after extravascular administration)		up to 72 hours post treatment	No
Secondary	Vz/F (apparent volume of distribution during the terminal phase ?z following an extravascular dose)		up to 72 hours post treatment	No
Secondary	Aet1-t2 (amount of analyte eliminated in urine from timepoint t1 to timepoint t2) SRD part only		up to 72 hours post treatment	No
Secondary	fet1-t2 (fraction of analyte eliminated in urine from timepoint t1 to timepoint t2) SRD part only		up to 72 hours post treatment	No
Secondary	CLR,t1-t2 (renal clearance of the analyte from timepoint t1 to timepoint t2) SRD part only[		up to 72 hours post treatment	No
Secondary	UFF/UFE ratio as an indicator of 11ß-HSD2 inhibition		up to 24h	No
Secondary	Total urinary corticosteroids (5a-THF + 5ß-THF + THE + UFF + UFE) as an indicator of the activation of the HPA axis		up to 24h	No