First in Man Trial of BI 113608

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01540825
First received: February 13, 2012
Last updated: December 5, 2012
Last verified: December 2012
  Purpose

The primary objective of the current study is to investigate the safety and tolerability of BI 113608 in healthy male volunteers following oral administration of single rising doses.

A secondary objective is the exploration of the pharmacokinetics of BI 113608 after single dosing.


Condition Intervention Phase
Healthy
Drug: BI 113608
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 113608 in Healthy Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Number of participants with changes from baseline in physical examination (as judged as adverse events) [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • Orthostasis test [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • Number of participants with changes from baseline in electrocardiogram (ECG) results [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • Number of participants with significant changes from baseline laboratory measurements [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • Lung function (Forced Expiratory Volume in 1 second (FEV1) and airway resistance (Raw) as measured by body plethysmography) [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • Carbon monoxyde diffusing capacity (DLCO) [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • Oxygen saturation (SpO2) as measured by non-invasive pulse oxymetry [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • Haemoccult testing [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • Assessment of tolerability by investigator (tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory and bad) [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • tmax (time from dosing to maximum measured concentration) [ Time Frame: Up to 13 weeks ] [ 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 13 weeks ] [ 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 13 weeks ] [ Designated as safety issue: No ]
  • t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: February 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 113608 high dose
Powder for oral solution
Drug: BI 113608
High dose powder for oral solution
Experimental: BI 113608 low dose
Powder for oral solution
Drug: BI 113608
Low dose powder for oral solution
Experimental: BI 113608 low dose
Powder for oral solution
Drug: BI 113608
Low dose powder for oral solution
Experimental: BI 113608 low dose
Powder for oral solution
Drug: BI 113608
Low dose powder for oral solution
Experimental: BI 113608 low dose
Powder for oral solution
Drug: BI 113608
Low dose powder for oral solution
Experimental: BI 113608 medium dose
Powder for oral solution
Drug: BI 113608
Medium dose powder for oral solution
Experimental: BI 113608 medium dose
Powder for oral solution
Drug: BI 113608
Medium dose powder for oral solution
Experimental: BI 113608 medium dose
Powder for oral solution
Drug: BI 113608
Medium dose powder for oral solution
Experimental: BI 113608 high dose
Powder for oral solution
Drug: BI 113608
High dose powder for oral solution
Experimental: BI 113608 high dose
Powder for oral solution
Drug: BI 113608
High dose powder for oral solution
Placebo Comparator: Placebo
Powder for oral solution
Drug: Placebo
Powder for oral solution

  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: NCT01540825

Locations
Germany
1314.1.1 Boehringer Ingelheim Investigational Site
Mannheim, 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: NCT01540825     History of Changes
Other Study ID Numbers: 1314.1, 2011-005034-19
Study First Received: February 13, 2012
Last Updated: December 5, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on August 19, 2014