Relative Bioavailability, Pharmacokinetics, Safety and Tolerability of BIIL 284 BS in Healthy Volunteers

NCT02265640 | Completed Phase 1

• 1 other identifier: 543.28
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of the present study is to investigate the relative bioavailability of BIIL 284 BS boli in comparison to the tablet C at a dose of 75 mg in fasted condition and after a standard breakfast in healthy male volunteers

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Plasma levels of BIIL 315 ZW

  up to 72 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 72 hours after drug administration

• Cmax (Maximum measured concentration of the analyte in plasma)

  up to 72 hours after drug administration

Secondary Outcomes (8)

• tmax (Time from dosing to the maximum concentration of the analyte in plasma)

  up to 72 hours after drug administration

• t½ (Terminal half-life of the analyte in plasma)

  up to 72 hours after drug administration

• MRTtot (Total mean residence time)

  up to 72 hours after drug administration

• Vz/F (Apparent volume of distribution of the analyte during the terminal phase)

  up to 72 hours after drug administration

• CLtot/F (Total clearance after oral administration)

  up to 72 hours after drug administration

Study Arms (4)

BIIL 284 BS boli - fasted

EXPERIMENTAL

Drug: BIIL 284 BS boli

BIIL 284 BS boli - fed

EXPERIMENTAL

Drug: BIIL 284 BS boli; Other: standard breakfast

BIIL 284 BS tablet C - fasted

ACTIVE COMPARATOR

Drug: BIIL 284 BS tablet C

BIIL 284 BS tablet C - fed

ACTIVE COMPARATOR

Drug: BIIL 284 BS tablet C; Other: standard breakfast

Interventions

BIIL 284 BS boli DRUG

BIIL 284 BS boli - fasted; BIIL 284 BS boli - fed

BIIL 284 BS tablet C DRUG

BIIL 284 BS tablet C - fasted; BIIL 284 BS tablet C - fed

standard breakfast OTHER

BIIL 284 BS boli - fed; BIIL 284 BS tablet C - fed

Eligibility Criteria

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

You may qualify if:

• All participants are healthy males
• Age range from 21 to 50 years
• Broca-Index: within +- 20% of normal weight

You may not qualify if:

• Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
• History of orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Intake of a drug with a long half-life (\> 24 hours) within one month or less than ten half-lives of the respective drug before enrollment in the study
• Use of any drugs which might influence the results of the trial (\>= one week prior to administration or during the trial)
• Participation in another study with an investigational drug (\>= tow months prior to administration or during the trial)
• Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
• Inability to refrain from smoking on study days
• Alcohol abuse (\> 60g/day)
• Drug abuse
• Blood donation (\>= 100 mL) within four weeks prior to administration or during the trial
• Excessive physical activities (within the last week before the study)

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: October 15, 2014
• First Posted: October 16, 2014
• Study Start: October 1, 2000
• Primary Completion: December 1, 2000
• Last Updated: October 16, 2014

Record last verified: 2014-10