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Safety Tolerability and Pharmacokinetic of BI 411034

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01581684
First received: April 19, 2012
Last updated: February 6, 2013
Last verified: February 2013
History of Changes
  Purpose

The primary objective of the current study is to investigate the safety, tolerability and pharmacokinetics of BI 411034 in healthy male volunteers following oral administration of single rising doses.

The secondary objective is to explore dose proportionality of BI 411034 in CYP2C19 (Cytochrome P450) genotyped extensive metabolisers (EM).

Another objective is to compare the safety and pharmacokinetic profiles between two different groups of CYP2C19 genotyped subjects, extensive metabolisers (EM) and poor metabolisers (PM)


Condition Intervention Phase
Healthy
 Drug: BI 411034
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 411034 in Healthy Male Volunteers (Randomised, Single-blind, Placebo-controlled Within Dose Groups, Phase I Study)

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Number of participants with clinically relevant findings in physical examination [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
  • Number of participants with clinically significant abnormalities in electrocardiogram (ECG) results [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
  • Number of participants with significant changes from baseline laboratory measurements [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
  • tmax (time from dosing to maximum measured concentration) [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
  • AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
  • Ae0-t1 (amount of analyte eliminated in urine from the time point 0 to time point t1) [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: April 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 411034 low dose
Solution for oral administration
 Drug: BI 411034
Low dose solution for oral administration
Experimental: BI 411034 low dose
Solution for oral administration
 Drug: BI 411034
Low dose solution for oral administration
Experimental: BI 411034 medium dose
Solution for oral administration
 Drug: BI 411034
Medium dose solution for oral administration
Experimental: BI 411034 medium dose
Solution for oral administration
 Drug: BI 411034
Medium dose solution for oral administration
Experimental: BI 411034 medium dose
Solution for oral administration
 Drug: BI 411034
Medium dose solution for oral administration
Experimental: BI 411034 high dose
Solution for oral administration
 Drug: BI 411034
High dose solution for oral administration
Experimental: BI 411034 high dose
Solution for oral administration
 Drug: BI 411034
High dose solution for oral administration
Experimental: BI 411034 high dose
Solution for oral administration
 Drug: BI 411034
High dose solution for oral administration
Placebo Comparator: Placebo
Solution for oral administration
 Drug: Placebo
Solution for oral administration

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581684

Locations
Germany
1308.1.1 Boehringer Ingelheim Investigational Site
Ingelheim, Germany
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01581684     History of Changes
Other Study ID Numbers: 1308.1, 2011-004840-23
Study First Received: April 19, 2012
Last Updated: February 6, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on June 17, 2013