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To Investigate the Safety, Tolerability, Pharmacokinetics and the Relative Bioavailability of BI 1026706

This study has been completed.
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: January 7, 2013
Last updated: July 6, 2015
Last verified: July 2015
To investigate the safety, tolerability, pharmacokinetics and the relative bioavailability of BI 1026706

Condition Intervention Phase
Drug: BI 1026706 Placebo
Drug: BI 1026706
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1026706 in Healthy Male Volunteers in a Partially Randomised, Single-blind, Placebo-controlled Trial, and Investigation of Relative Bioavailability of BI 1026706 (Open-label, Randomised, Four-way Cross-over)

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Number of subjects (%) with drug related adverse events (AEs) [ Time Frame: up to 72 hours ]

Secondary Outcome Measures:
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 72 hours ]
  • tmax (time from dosing to maximum measured concentration) [ Time Frame: up to 72 hours ]
  • 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 72 hours ]
  • 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 ]
  • t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 72 hours ]
  • fet1-t2 (fraction of analyte eliminated in urine from the time point t1 to time point t2) [ Time Frame: up to 72 hours ]

Enrollment: 80
Study Start Date: January 2013
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 BI 1026706 single rising dose part
single rising doses of BI 1026706
Drug: BI 1026706 Placebo
Placebo to BI 1026706
Drug: BI 1026706
single dose (low to high dose)
Experimental: 2 BI 1026706 bioavailability part
bioavailability part of BI 1026706
Drug: BI 1026706
different dose formulations


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion criteria:

1. healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

  Contacts and Locations
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Please refer to this study by its identifier: NCT01763333

1320.1.1 Boehringer Ingelheim Investigational Site
Ingelheim, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim Identifier: NCT01763333     History of Changes
Other Study ID Numbers: 1320.1
2012-002366-12 ( EudraCT Number: EudraCT )
Study First Received: January 7, 2013
Last Updated: July 6, 2015 processed this record on April 26, 2017