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Bioavailability and Pharmacokinetics of BI 135585 XX Administered as Tablet With and Without Food

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ClinicalTrials.gov Identifier: NCT01286571
Recruitment Status : Completed
First Posted : January 31, 2011
Last Update Posted : November 1, 2013
Sponsor:
Information provided by:
Boehringer Ingelheim

Brief Summary:
The objective of this study is to investigate the effect of food on the relative bioavailability of a 50 mg BI 135585 XX tablet.

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 135585 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioavailability and Pharmacokinetics of 50 mg BI 135585 XX Administered as Tablet With and Without Food to Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover Study)
Study Start Date : January 2011
Actual Primary Completion Date : March 2011

Arm Intervention/treatment
Experimental: BI 135585 (T)
single dose per subject as tablet formulation after high fat, high caloric meal
Drug: BI 135585
one oral single dose per subject
Experimental: BI 135585 (R)
single dose per subject as tablet formulation after an overnight fast
Drug: BI 135585
one oral single dose per subject



Primary Outcome Measures :
  1. Area under the concentration-time curve of BI 135585 in plasma over the time interval from 0 hours extrapolated to infinity [ Time Frame: up to 144 hours post treatment ]
  2. Maximum measured concentration of the analyte in plasma of BI 135585 in plasma over the time interval from 0 hours extrapolated to infinity [ Time Frame: up to 144 hours post treatment ]

Secondary Outcome Measures :
  1. 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 144 hours post treatment ]
  2. Physical examination (occurrence of findings) [ Time Frame: up to 14 days post treatment ]
  3. %AUCtz-∞ (percentage of AUC0-∞ obtained by extrapolation) [ Time Frame: up to 144 hours post treatment ]
  4. tmax (time from dosing to maximum measured concentration) [ Time Frame: up to 144 hours post treatment ]
  5. λz (terminal rate constant in plasma) [ Time Frame: up to 144 hours post treatment ]
  6. t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 144 hours post treatment ]
  7. MRTpo (mean residence time of the analyte in the body after oral administration) [ Time Frame: up to 144 hours post treatment ]
  8. CL/F (total/apparent clearance of the analyte in plasma after extravascular administration) [ Time Frame: up to 144 hours post treatment ]
  9. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: up to 144 hours post treatment ]
  10. Vital signs (blood pressure, pulse rate) [ Time Frame: up to 14 days post treatment ]
  11. 12-lead ECG (electrocardiogram) [ Time Frame: up to 14 days post treatment ]
  12. Clinical laboratory parameters (haematology, enzymes, substrates, electrolytes, hormones of the HPA axis and the thyroid gland, and urinalysis) [ Time Frame: up to 14 days post treatment ]
  13. Incidence and severity of Adverse events [ Time Frame: up to 14 days post treatment ]
  14. Assessment of tolerability by the investigator [ Time Frame: up to 14 days post treatment ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

- healthy male subjects

Exclusion criteria:

- Any relevant deviation from healthy conditions


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01286571


Locations
Germany
1283.3.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01286571     History of Changes
Other Study ID Numbers: 1283.3
2010-022697-14 ( EudraCT Number: EudraCT )
First Posted: January 31, 2011    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013