Effect of Different Food Compositions on Bioavailability of BIIL 284 BS in Healthy Male Volunteers

NCT02273427 | Completed Phase 1

• 1 other identifier: 543.5
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

food effect, relative bioavailability, pharmacokinetics, safety and tolerability

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Maximum concentration (Cmax)

  up to 72 hours after drug administration

• Area under the concentration time curve from timepoint zero extrapolated to infinity (AUC-infinity)

  up to 72 hours after drug administration

Secondary Outcomes (9)

• Time to Cmax (tmax)

  up to 72 hours after drug administration

• Area under the concentration time curve from timepoint zero to time of last data point above limit of quantification (AUC-tz)

  up to 72 hours after drug administration

• Terminal half-life (t1/2)

  up to 72 hours after drug administration

• Total mean residence time (MRTtot)

  up to 72 hours after drug administration

• Volume of distribution during terminal phase after oral administration (Vz/F)

  up to 72 hours after drug administration

Study Arms (3)

BIIL 284 BS fasted

ACTIVE COMPARATOR

Drug: BIIL 284 BS

BIIL 284 BS with high fat meal

EXPERIMENTAL

Drug: BIIL 284 BS; Other: high fat meal

BIIL 284 BS with low fat meal

EXPERIMENTAL

Drug: BIIL 284 BS; Other: low fat meal

Interventions

BIIL 284 BS DRUG

BIIL 284 BS fasted; BIIL 284 BS with high fat meal; BIIL 284 BS with low fat meal

high fat meal OTHER

BIIL 284 BS with high fat meal

low fat meal OTHER

BIIL 284 BS with low fat meal

Eligibility Criteria

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

You may qualify if:

• All participants in the study should be healthy caucasian males as determined by the results of screening, range from 21 to 50 years of age and be within +- 20% of their normal weight (Broca-Index)
• All volunteers will have given their written informed consent in accordance with Good Clinical Practice and local legislation prior to admission to the study

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 psychiatric disorders or neurological 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 drugs with a long half-life (\> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment 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 trial with an investigational drug (\<= 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 (\> 60 g/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

MeSH Terms

Interventions

amelubant

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 23, 2014
• First Posted: October 24, 2014
• Study Start: February 1, 2000
• Primary Completion: March 1, 2000
• Last Updated: October 24, 2014

Record last verified: 2014-10