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

NCT02265653 | Completed Phase 1

• 1 other identifier: 543.3
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of the present study is to investigate the relative bioavailability of two BIIL 284 BS tablets (tablet C and tablet C) in comparison to the WIF tablet at a dose of 75 mg following a standard breakfast in healthy male volunteers

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• 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

• 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

Secondary Outcomes (3)

• Number of subjects with adverse events

  up to 8 days after last drug administration

• Number of subjects with clinically findings in vital functions

  up to 8 days after last drug administration

• Number of subjects with clinically findings in laboratory tests

  up to 8 days after last drug administration

Study Arms (3)

BIIL 284 BS tablet C

EXPERIMENTAL

Drug: BIIL 284 BS tablet C

BIIL 284 BS tablet D

EXPERIMENTAL

Drug: BIIL 284 BS tablet D

BIIL 284 BS WIF tablet

ACTIVE COMPARATOR

Drug: BIIL 284 BS WIF tablet

Interventions

BIIL 284 BS tablet C DRUG

BIIL 284 BS tablet C

BIIL 284 BS tablet D DRUG

BIIL 284 BS tablet D

BIIL 284 BS WIF tablet DRUG

BIIL 284 BS WIF tablet

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 their normal weight
• In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give their written informed consent prior to admission to the study

You may not qualify if:

• Volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
• Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
• Volunteers with history of orthostatic hypotension, fainting spells or blackouts
• Volunteers with chronic or relevant acute infections
• Volunteers with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Volunteers who have taken 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
• Volunteers who received any drugs which might influence the results of the trial the week previous to the start of the study
• Volunteers who participated in another study with an investigational drug within the last two months preceding this study
• Volunteers who smoke (\> 10 cigarettes or 3 cigars or 3 pipes/day)
• Volunteers who drink more than 60g of alcohol per day
• Volunteers who are dependent on drugs
• Volunteers who participated in excessive physical activities (e.g. competitive sports) within the last week before the study
• Volunteers who have donated blood within the last 4 weeks (\>= 100 mL)

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: November 1, 1999
• Primary Completion: December 1, 1999
• Last Updated: October 16, 2014

Record last verified: 2014-10