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Bioavailability of 3 Different Formulations of BI 207127 in Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01535638
First received: February 15, 2012
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

The primary objective of the current study is to investigate the relative bioavailability of three trial formulations of BI 207127, the trial formulation 2 (TFII), the final formulation (FF), and a FF modified formulation. All formulations are supplied as film-coated Tablets and administered as single dose treatments of BI 207127 (3 film-coated Tablets) in healthy volunteers, with the aim to compare the bioavailability of the three formulations. All treatments will be applied fed, 30 minutes after start of the intake of a standard normal breakfast.


Condition Intervention Phase
Healthy
Drug: BI 207127
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Relative Bioavailability of BI 207127 FF Tablets, BI 207127 FF Modified Tablets and BI 207127 TFII Tablets Administered Orally as Three Tablets (Single Dose) to Healthy Male Volunteers, an Open-label, Randomised Three-way Crossover Study

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity), BI 207127 [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]
  • Cmax (maximum measured concentration of the analyte in plasma), BI 207127 [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • tmax (time from dosing to the maximum concentration of the analyte in plasma), BI 207127 and metabolites [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]
  • λz (terminal rate constant in plasma), BI 207127 and metabolites [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]
  • t1/2 (terminal half-life of the analyte in plasma), BI 207127 and metabolites [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]
  • MRTpo (mean residence time of the analyte in the body after p.o. administration), BI 207127 and metabolites [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]
  • CL/F (apparent clearance of the analyte in the plasma after extravascular administration). BI 207127 and metabolites [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]
  • Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose), BI 207127 and metabolites [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]
  • RCmax,Met (the ratio of Cmax of the BI 207127 metabolites to Cmax of the parent compound, BI 207127) [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]
  • RAUC0- infinity Met (the ratio of AUC0- infinity of the BI 207127 metabolites to AUC0- infinity of the parent compound, BI 207127) [ Time Frame: up to 21 days ] [ 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), BI 207127 metabolites [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]
  • Cmax (maximum measured concentration of the analyte in plasma), BI 207127 metabolites [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]
  • Changes in Physical examination [ Time Frame: Baseline, up to 28 days ] [ Designated as safety issue: No ]
  • Changes in Vital signs (BP, PR) [ Time Frame: Baseline, up to 28 days ] [ Designated as safety issue: No ]
  • Changes in 12-lead ECG (electrocardiogram) [ Time Frame: Baseline, up to 28 days ] [ Designated as safety issue: No ]
  • Changes in Clinical laboratory tests (haematology, clinical chemistry and urinalysis) [ Time Frame: Baseline, up to 28 days ] [ Designated as safety issue: No ]
  • Incidence and intensity of adverse events [ Time Frame: up to 7 weeks ] [ Designated as safety issue: No ]
  • Assessment of tolerability by investigator [ Time Frame: at end of each treatment period ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: February 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BI 207127 NA TFII medium dose
Film-coated tablet for oral administration
Drug: BI 207127
Medium dose film-coated tablet
Active Comparator: BI 207127 NA FF medium dose
Film-coated tablet for oral administration
Drug: BI 207127
Medium dose film-coated tablet
Active Comparator: BI 207127 NA FF modified medium dose
Film-coated tablet for oral administration
Drug: BI 207127
Medium dose film-coated tablet

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Healthy males according to a complete medical history, including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
  2. Age =21and Age =50 years
  3. Body mass index =18.5 and BMI = 29.9 kg/m2
  4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.

Exclusion criteria:

  1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
  2. Any evidence of a clinically relevant concomitant disease
  3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  4. Surgery of the gastrointestinal tract (except appendectomy)
  5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  6. History of relevant orthostatic hypotension, fainting spells or blackouts
  7. Chronic or relevant acute infections
  8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  9. Intake of drugs with a long half-life (> 24 hours) within at least 10 half-lifes prior to administration of the trial drug or during the trial
  10. Use of drugs which might reasonably influence the results of the trial within 10 days prior to administration or during the trial
  11. Participation in another trial with an investigational drug within two months prior to administration of the trial drug or during the trial
  12. Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
  13. Alcohol abuse (more than 40 g/day)
  14. Drug abuse
  15. Blood donation (more than 100 mL within four weeks prior to first administration of the trial drug or during the trial)
  16. Excessive physical activities (within one week prior to first administration of the trial drug or during the trial)
  17. Any laboratory value outside the reference range that is of clinical relevance
  18. Inability to comply with dietary regimen of trial site
  19. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
  20. A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
  21. History of photosensitivity or recurrent rash
  22. Subject is not willing to avoid sun exposure from the first administration of the trial drug until the end of the study.
  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: NCT01535638

Locations
Germany
1241.26.1 Boehringer Ingelheim Investigational Site
Ingelheim, 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: NCT01535638     History of Changes
Other Study ID Numbers: 1241.26
Study First Received: February 15, 2012
Last Updated: November 1, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on November 27, 2014