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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BIBX 245 CL- fasted; Drug: BIBX 245 CL - fed

• Registration Number: NCT02264197
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Study Timeline

• Study Start: 1998-05
• Primary Completion: 1998-06
• Status Verified: 2014-10
• Study First Submitted: 2014-10-14
• Study First Submitted QC: 2014-10-14
• Last Update Submitted: 2014-10-14
• Study First Posted: 2014-10-15
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

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

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Exclusion Criteria

• 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)
• Excessive physical activities (<= 10 days prior to administration or during the trial)
• Any laboratory value outside the reference range or clinical relevance

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BIBX 245 CL - fasted	BIBX 245 CL- fasted	-
BIBX 245 CL - fed	BIBX 245 CL - fed	after a light breakfast with 40 g fat

Primary Outcome Measures

Name	Time	Method
Cmax (Maximum measured concentration of the analyte in plasma)	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
MRTtot (Mean residence time)	up to 24 hours post dose
t½ (Terminal half-life 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
λz (Terminal rate constant in plasma)	up to 24 hours post dose

Secondary Outcome Measures

Name	Time	Method
Number of subjects with adverse events	up to 20 days
Assessment of tolerability by investigator	after 20 days