Relative Oral Bioavailability of BI 44847 as Suspension Compared to Tablet and the Influence of Food Anf of BI 44847 as Solution Compared to Tablet in Healthy Male Volunteers

NCT02211937 | Completed Phase 1

• 1 other identifier: 1224.2
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate the relative oral bioavailability of 400 mg BI 44847 as suspension vs. 400 mg BI 44847 as tablet, to investigate a food effect on the 400 mg tablet pharmacokinetic (PK) and to investigate relative oral bioavailability of 40 mg BI 44847 as solution vs. 40 mg BI 44847 as tablet.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Cmax (maximum concentration of the analyte in plasma)

  up to 48 hours after drug administration

• 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 48 hours after drug administration

• AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  up to 48 hours after drug administration

Secondary Outcomes (14)

• λz (terminal rate constant in plasma)

  up to 48 hours after drug administration

• t1/2 (terminal half-life of the analyte in plasma)

  up to 48 hours after drug administration

• MRTpo (mean residence time of the analyte in the body after po administration)

  up to 48 hours after drug administration

• CL/F (total clearance of the analyte in the plasma after extravascular administration)

  up to 48 hours after drug administration

• Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)

  up to 48 hours after drug administration

Study Arms (5)

Treatment A

ACTIVE COMPARATOR

BI 44847 suspension high dose, fasted

Drug: BI 44847 suspension, high dose

Treatment B

EXPERIMENTAL

BI 44847 tablet high dose, fasted

Drug: BI 44847 tablet, high dose

Treatment C

EXPERIMENTAL

BI 44847 tablet high dose, fed

Drug: BI 44847 tablet, high dose; Other: high fat breakfast

Treatment D

ACTIVE COMPARATOR

BI 44847 solution low dose, fasted

Drug: BI 44847 solution, low dose

Treatment E

EXPERIMENTAL

BI 44847 tablet low dose, fasted

Drug: BI 44847 tablet, low dose

Interventions

BI 44847 solution, low dose DRUG

Treatment D

BI 44847 suspension, high dose DRUG

Treatment A

BI 44847 tablet, low dose DRUG

Treatment E

BI 44847 tablet, high dose DRUG

Treatment B; Treatment C

high fat breakfast OTHER

Treatment C

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 ≤ 50 years
• BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

You may not qualify if:

• 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
• 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 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 8, 2014
• Study Start: January 1, 2007
• Primary Completion: March 1, 2007
• Last Updated: August 8, 2014

Record last verified: 2014-08