Bioavailability of 3 Different Formulations of BI 207127 - Full Text View

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 Pharmaceuticals:

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) [ Time Frame: up to 13 weeks ] [ Designated as safety issue: No ]
Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 13 weeks ] [ 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:

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
Age =21and Age =50 years
Body mass index =18.5 and BMI = 29.9 kg/m2
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:

Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
History of relevant orthostatic hypotension, fainting spells or blackouts
Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
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
Use of drugs which might reasonably influence the results of the trial within 10 days prior to administration or during the trial
Participation in another trial with an investigational drug within two months prior to administration of the trial drug or during the trial
Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
Alcohol abuse (more than 40 g/day)
Drug abuse
Blood donation (more than 100 mL within four weeks prior to first administration of the trial drug or during the trial)
Excessive physical activities (within one week prior to first administration of the trial drug or during the trial)
Any laboratory value outside the reference range that is of clinical relevance
Inability to comply with dietary regimen of trial site
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
History of photosensitivity or recurrent rash
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

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 Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01535638 History of Changes
Other Study ID Numbers:	1241.26
Study First Received:	February 15, 2012
Last Updated:	September 18, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on June 18, 2013