Single Rising Dose Study of BI 144807 Powder in Bottle in Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01480648
First received: November 21, 2011
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

This first-in-man trial forms the basis for potential clinical development of BI 144807 in the indications of asthma and allergic rhinitis. The safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising doses of BI 144807 will be assessed in healthy male volunteers.


Condition Intervention Phase
Healthy
Drug: BI 144807 Placebo
Drug: BI 144807
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses of BI 144807 Powder in Bottle (1 to 1200 mg) in Healthy Male Volunteers in a Randomised, Single-blind, Placebo-controlled Trial

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • All adverse events [ Time Frame: up to 14 days postdose ] [ Designated as safety issue: No ]
  • Number of participants with clinically significant changes in vital signs [ Time Frame: up to 14 days postdose ] [ Designated as safety issue: No ]
  • Number of participants with clinically significant changes in ECG [ Time Frame: up to 14 days postdose ] [ Designated as safety issue: No ]
  • Number of participants with clinically significant changes in laboratory tests [ Time Frame: up to 14 days postdose ] [ Designated as safety issue: No ]
  • Number of participants with clinically significant changes in physical examination [ Time Frame: up to 14 days postdose ] [ Designated as safety issue: No ]
  • Number of participants tolerating BI 144807 [ Time Frame: up to 14 days postdose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 72h postdose ] [ Designated as safety issue: No ]
  • tmax (time from dosing to maximum measured concentration) [ Time Frame: up to 72h postdose ] [ Designated as safety issue: No ]
  • AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 72h postdose ] [ Designated as safety issue: No ]
  • AUC(0-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 72h postdose ] [ Designated as safety issue: No ]
  • t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 72h postdose ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: November 2011
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI144807
Subjects receive a single oral dose of BI144807solution
Drug: BI 144807
single dose (low to high dose)
Placebo Comparator: Placebo
Subjects receive a single oral dose of placebo solution
Drug: BI 144807 Placebo
Placebo that represents BI drug

  Eligibility

Ages Eligible for Study:   18 Years to 45 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: NCT01480648

Locations
Germany
1313.1.1 Boehringer Ingelheim Investigational Site
Biberach, 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: NCT01480648     History of Changes
Other Study ID Numbers: 1313.1, 2011-002560-24
Study First Received: November 21, 2011
Last Updated: October 31, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on July 20, 2014