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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01763333
First received: January 7, 2013
Last updated: September 23, 2013
Last verified: September 2013
  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
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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 72 hours ] [ Designated as safety issue: No ]
  • tmax (time from dosing to maximum measured concentration) [ Time Frame: up to 72 hours ] [ 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 72 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 72 hours ] [ Designated as safety issue: No ]
  • fet1-t2 (fraction of analyte eliminated in urine from the time point t1 to time point t2) [ Time Frame: up to 72 hours ] [ Designated as safety issue: No ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01763333     History of Changes
Other Study ID Numbers: 1320.1, 2012-002366-12
Study First Received: January 7, 2013
Last Updated: September 23, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on November 25, 2014