Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 135585 XX in Patients With Type 2 Diabetes

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Placebo to BI 135585; Drug: BI 135585

• Registration Number: NCT01282970
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of this study is to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 135585 XX following multiple dose administration over 14 days

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-24
• Study First Submitted QC: 2011-01-24
• Study First Posted: 2011-01-25
• Study Start: 2011-02
• Primary Completion: 2011-07
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-18
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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
Placebo to BI 135585	Placebo to BI 135585	once daily doses as oral solution or tablet formulation over 14 days
BI 135585	BI 135585	once daily doses as oral solution or tablet formulation over 14 days

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of BI 135585 will be assessed in a descriptive way using physical examinations (occurence of findings), vital signs, electrocardiograms, laboratory tests, and incidence and severity of adverse events.	up to 16 days post treatment

Secondary Outcome Measures

Name	Time	Method
Assessment of Pharmacokinetic parameter fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) of BI 135585 following single and multiple dose oral administration	up to 10 days post treatment
Assessment of Pharmacokinetic parameter Cmax (maximum measured concentration of the analyte in plasma) of BI 135585 following single and multiple dose oral administration	up to 10 days post treatment
Assessment of Pharmacokinetic parameter tmax (time from dosing to maximum measured concentration) of BI 135585 following single and multiple dose oral administration	up to 10 days post treatment
Assessment of Pharmacokinetic parameter Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose) of BI 135585 following single and multiple dose oral administration	up to 10 days post treatment
Assessment of Pharmacokinetic parameter Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration) of BI 135585 following single and multiple dose oral administration	up to 10 days post treatment
Assessment of Pharmacokinetic parameter Cavg (average concentration of the analyte in plasma at steady state) of BI 135585 following single and multiple dose oral administration	up to 10 days post treatment
Assessment of Pharmacokinetic parameter Aet1-t2,ss (amount of analyte that is eliminated in urine at steady state from the time point t1 to time point t2) of BI 135585 following single and multiple dose oral administration	up to 10 days post treatment
Assessment of Pharmacokinetic parameter CLR,t1-t2,ss (renal clearance of the analyte in plasma from the time point t1 until the time point t2 at steady state) of BI 135585 following single and multiple dose oral administration	up to 10 days post treatment
Assessment of Pharmacokinetic parameter AUCτ,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose)	up to 10 days post treatment
Assessment of Pharmacokinetic parameter λz (terminal rate constant in plasma) of BI 135585 following single and multiple dose oral administration	up to 10 days post treatment
Assessment of Pharmacokinetic parameter CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) of BI 135585 following single and multiple dose oral administration	up to 10 days post treatment
Assessment of Pharmacokinetic parameter tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state) of BI 135585 following single and multiple dose oral administration	up to 10 days post treatment
Assessment of Pharmacokinetic parameter CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration) of BI 135585 following single and multiple dose oral administration	up to 10 days post treatment
Assessment of Pharmacokinetic parameter PTF (Peak-Trough Fluctuation) of BI 135585 following single and multiple dose oral administration	up to 10 days post treatment
Assessment of Pharmacokinetic parameter Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) of BI 135585 following single and multiple dose oral administration	up to 10 days post treatment
Assessment of Pharmacokinetic parameter MRTpo,ss (mean residence time of the analyte in the body after multiple oral administrations at steady state) of BI 135585 following single and multiple dose oral administration	up to 10 days post treatment
Assessment of Pharmacokinetic parameter Cpre,N (the predose concentration of the analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered)	up to 10 days post treatment
Assessment of Pharmacokinetic parameter Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of BI 135585 following single and multiple dose oral administration	up to 10 days post treatment
Assessment of Pharmacokinetic parameter AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) of BI 135585 following single and multiple dose oral administration	up to 10 days post treatment
Assessment of Pharmacokinetic parameter λz,ss (terminal rate constant in plasma at steady state) of BI 135585 following single and multiple dose oral administration	up to 10 days post treatment
Assessment of Pharmacokinetic parameter fet1-t2,ss (fraction of analyte eliminated in urine at steady state from time point t1 to time point t2) of BI 135585 following single and multiple dose oral administration	up to 10 days post treatment
Exploratory evaluation of the pharmacodynamics of BI 135585 by measuring of cortisol and cortisone and their metabolites in urine	up to 24 hours post treatment
Assessment of Pharmacokinetic parameter t1/2,ss (terminal half-life of the analyte in plasma at steady state) of BI 135585 following single and multiple dose oral administration	up to 10 days post treatment
Assessment of Pharmacokinetic parameter RA,Cmax (Accumulation ratio of the analyte in plasma at steady state after multiple dose oral administration over a uniform dosing interval τ, expresses ratio of Cmax at steady state and after single dose)	up to 10 days post treatment
Assessment of Pharmacokinetic parameter RA,AUC (Accumulation ratio of the analyte in plasma at steady state after multiple dose oral administration over a uniform dosing interval τ, expresses ratio of AUC at steady state and after single dose)	up to 10 days post treatment
Exploratory evaluation of the pharmacodynamics of BI 135585 by determination of 11beta-hydroxysteroid dehydrogenase type 1 activity in adipose tissue (ex vivo)	up to 24 hours post treatment

Trial Locations

Locations (1)

1283.2.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Neuss, Germany