Investigation of Pharmacokinetics of BIBX 245 CL and Safety in Healthy Subjects

NCT02264197 | Completed Phase 1

• 1 other identifier: 537.7
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim of this trial is to investigate the single dose pharmacokinetics and the effect of food on single dose of 160 mg 245 CL (two 80 mg tablets) as well as its safety

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

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

  up to 24 hours post dose

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

  up to 24 hours post dose

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

  up to 24 hours post dose

• λz (Terminal rate constant in plasma)

  up to 24 hours post dose

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

  up to 24 hours post dose

• MRTtot (Mean residence time)

  up to 24 hours post dose

Secondary Outcomes (2)

• Number of subjects with adverse events

  up to 20 days

• Assessment of tolerability by investigator

  after 20 days

Study Arms (2)

BIBX 245 CL - fed

EXPERIMENTAL

after a light breakfast with 40 g fat

Drug: BIBX 245 CL - fed

BIBX 245 CL - fasted

ACTIVE COMPARATOR

Drug: BIBX 245 CL- fasted

Interventions

BIBX 245 CL - fed DRUG

BIBX 245 CL - fed

BIBX 245 CL- fasted DRUG

BIBX 245 CL - fasted

Eligibility Criteria

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

You may qualify if:

• Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
• Age \>= 18 and \<= 50 years
• Broca \>= -20% and \<= +20%

You may not qualify if:

• Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram (ECG)) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurologic 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) (\<= 1 month prior to administration or during the trial)
• Use of any drugs which might influence the results of the trial (\<= 10 days prior to administration or during the trial)
• Participation in another trial with an investigational drug (\<= 2 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 (\> 60 g/day)
• Drug abuse
• Blood donation \> 100 ml (\<= 4 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: October 14, 2014
• First Posted: October 15, 2014
• Study Start: May 1, 1998
• Primary Completion: June 1, 1998
• Last Updated: October 15, 2014

Record last verified: 2014-10