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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: November 23, 2016
Last verified: November 2016
  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
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:
  • Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, Lung Function, Carbon Monoxide Diffusing Capacity of the Lung, ECG, Physical Examination, Orthostasis Test, Oxygen Saturation or Haemoccult Test [ Time Frame: From administration of study drug until end-of-study visit, up to 10 days ]
    Clinically relevant abnormalities for clinical laboratory evaluation, vital signs, lung function, carbon monoxide Diffusing Capacity Of the Lung (DLCO), Electrocardiogram (ECG), physical examination, orthostasis test, oxygen saturation or haemoccult test

  • Percentage of Participants With Drug-related Adverse Events [ Time Frame: From administration of study drug until end-of-study visit, up to 10 days ]
    Percentage of participants with drug-related adverse events

  • Assessment of Tolerability by the Investigator [ Time Frame: End of study visit, up to day 10 ]
    Assessment of tolerability by the investigator assessed according to the categories good, satisfactory, not satisfactory, bad and not assessable.


Secondary Outcome Measures:
  • Cmax [ Time Frame: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration ]

    Maximum measured concentration of the analyte in plasma (Cmax).

    The analysis population was the pharmacokinetic (PK) set which included all subjects randomised and treated with study medication who provided at least 1 evaluable observation for a PK endpoint of Area Under the Concentration-time Curve from 0 to infinity (AUC0-inf), Area Under the Concentration-time Curve from 0 to the last quantifiable data point (AUC0-tz) and Cmax and who had no important protocol violations relevant to the evaluation of PK.


  • Tmax [ Time Frame: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration ]
    Time from dosing to maximum measured concentration of the analyte in plasma (Tmax)

  • AUC0-tz [ Time Frame: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration ]
    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 (AUC0-tz)

  • AUC0-infinity [ Time Frame: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration ]
    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity)

  • t1/2 [ Time Frame: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration ]
    Terminal half-life of the analyte in plasma (t1/2)


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 1
Powder for oral solution
Drug: BI 113608
High dose powder for oral solution
Experimental: BI 113608 low dose 1
Powder for oral solution
Drug: BI 113608
Low dose powder for oral solution
Experimental: BI 113608 low dose 2
Powder for oral solution
Drug: BI 113608
Low dose powder for oral solution
Experimental: BI 113608 low dose 4
Powder for oral solution
Drug: BI 113608
Low dose powder for oral solution
Experimental: BI 113608 low dose 5
Powder for oral solution
Drug: BI 113608
Low dose powder for oral solution
Experimental: BI 113608 medium dose 1
Powder for oral solution
Drug: BI 113608
Medium dose powder for oral solution
Experimental: BI 113608 medium dose 2
Powder for oral solution
Drug: BI 113608
Medium dose powder for oral solution
Experimental: BI 113608 medium dose 3
Powder for oral solution
Drug: BI 113608
Medium dose powder for oral solution
Experimental: BI 113608 high dose 2
Powder for oral solution
Drug: BI 113608
High dose powder for oral solution
Experimental: BI 113608 high dose 3
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   (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
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
Boehringer Ingelheim Investigational Site
Mannheim, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01540825     History of Changes
Other Study ID Numbers: 1314.1
2011-005034-19 ( EudraCT Number: EudraCT )
Study First Received: February 13, 2012
Results First Received: November 23, 2016
Last Updated: November 23, 2016

Additional relevant MeSH terms:
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on June 23, 2017