Clinical trial NCT02264197: Investigation of Pharmacokinetics of BIBX 245 CL and Safety in Healthy Subjects
Official title: Single-dose Pharmacokinetics of 160 mg BIBX 245 CL and Effect of Food After Oral Administration of Tablets to Healthy Subjects (Randomized, 2-way-cross-over, Open Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-15
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: Cmax (Maximum measured concentration of the analyte in plasma)
timeFrame: up to 24 hours post dose
measure: AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
timeFrame: up to 24 hours post dose
measure: tmax (Time from dosing to the maximum concentration of the analyte in plasma)
timeFrame: up to 24 hours post dose
measure: λz (Terminal rate constant in plasma)
timeFrame: up to 24 hours post dose
measure: t½ (Terminal half-life of the analyte in plasma)
timeFrame: up to 24 hours post dose
measure: MRTtot (Mean residence time)
timeFrame: up to 24 hours post dose
Secondary outcomes:
measure: Number of subjects with adverse events
timeFrame: up to 20 days
measure: Assessment of tolerability by investigator
timeFrame: after 20 days
Other outcomes:
Locations:
Study officials:
References: