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

History of Changes

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 February 27, 2015

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