Influence of a Standardised High Fat Breakfast on the Bioavailability of BI 14332 CL in Healthy Male Volunteers

Influence of a Standardised High Fat Breakfast on the Bioavailability of 10 mg BI 14332 CL Taken as Two Tablets of 5 mg q.d. in Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover Trial)

To investigate the relative bioavailability of BI 14332 CL vs. BI 14332 CL after intake of a standardised high fat breakfast

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: high fat breakfast; Drug: BI 14332 CL

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy males according to the following criteria:

Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests

• Age ≥21 and Age ≤65 years
• Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with 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 one month or less than 10 half-lives of the respective drug prior to administration or during the trial
• Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 60 g/day)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
• Excessive physical activities (within one week prior to administration 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 Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 14332 CL fasted	Drug: BI 14332 CL
Experimental: BI 14332 CL fed	Other: high fat breakfast; Drug: BI 14332 CL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)	up to 192 hours after drug administration
Cmax (maximum measured concentration of the analyte in plasma)	up to 192 hours after drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
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)	up to 192 hours after drug administration
AUCt1-t2 (partial area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2)	up to 192 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)	up to 192 hours after drug administration
λz (terminal rate constant in plasma)	up to 192 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)	up to 192 hours after drug administration
MRTpo (mean residence time of the analyte in the body after oral administration)	up to 192 hours after drug administration
CL/F (apparent clearance of the analyte in plasma after extravascular administration)	up to 192 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)	up to 192 hours after drug administration
Number of patients with adverse events	up to 23 days after last drug administration
Number of patients with clinically significant findings in vital signs (blood pressure, pulse rate)	up to 23 days after last drug administration
Number of patients with clinically significant findings in laboratory tests	up to 23 days after last drug administration
Number of patients with clinically significant findings in ECG	up to 23 days after last drug administration
Assessment of tolerability by investigator on a 4-point scale	up to 23 days after last drug administration

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): November 1, 2006

Study Registration Dates

• First Submitted: August 7, 2014
• First Submitted That Met QC Criteria: August 7, 2014
• First Posted (Estimate): August 8, 2014

Study Record Updates

• Last Update Posted (Estimate): August 8, 2014
• Last Update Submitted That Met QC Criteria: August 7, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 1233.3