Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 187004 CL

A Randomised, Double-blind, Placebo-controlled Trial in Healthy Volunteers to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of 2.5 mg to 360 mg of BI 187004 CL

To investigate safety, tolerability, pharmacokinetics including dose proportionality, and pharmacodynamics of BI 187004 CL within a predefined dose range

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 187004 CL; Drug: Placebo to BI 187004 CL

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany
    • 1307.1.1 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion criteria:

1. Healthy male subjects
2. overweight or obese

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 187004 CL; 1 single dose per subject as oral solution	Drug: BI 187004 CL; 1 single dose per subject as oral solution
Placebo Comparator: Placebo to BI 187004 CL; 1 single dose per subject as oral solution	Drug: Placebo to BI 187004 CL; 1 single dose per subject as oral solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of adverse events	up to 15 days postdose

Secondary Outcome Measures

Outcome Measure	Time Frame
Cmax (maximum measured concentration of the analyte in plasma)	up to 96 hours postdose
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 96 hours postdose
AUC0-8 (area under the concentration-time curve of the in plasma over the time interval from 0 extrapolated to infinity)	up to 96 hours postdose

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

General Publications

• Bianzano S, Heise T, Jungnik A, Schepers C, Scholch C, Grafe-Mody U. Safety, tolerability, pharmacokinetics and pharmacodynamics of single oral doses of BI 187004, an inhibitor of 11beta-hydroxysteroid dehydrogenase-1, in healthy male volunteers with overweight or obesity. Clin Diabetes Endocrinol. 2021 Aug 15;7(1):16. doi: 10.1186/s40842-021-00130-x.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: April 26, 2012
• First Submitted That Met QC Criteria: April 27, 2012
• First Posted (Estimate): April 30, 2012

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: 1307.1; 2011-006183-45 (EudraCT Number: EudraCT)