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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01763333
First Posted: January 8, 2013
Last Update Posted: July 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
To investigate the safety, tolerability, pharmacokinetics and the relative bioavailability of BI 1026706

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01763333


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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01763333     History of Changes
Other Study ID Numbers: 1320.1
2012-002366-12 ( EudraCT Number: EudraCT )
First Submitted: January 7, 2013
First Posted: January 8, 2013
Last Update Posted: July 7, 2015
Last Verified: July 2015