Clinical trial NCT02264119: Influence of Pantoprazole on the Pharmacokinetics of Fradafiban After Multiple Oral Doses of Lefradafiban in Healthy Subjects
Official title: Influence of 40 mg Pantoprazole Per Day on the Pharmacokinetics of Fradafiban After Multiple Oral Doses of 20 mg Lefradafiban Tid as Acid Free Tablet and Sachet Over 5 Days in Healthy Subjects. A 4-way Crossover Randomized Open Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-15
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study to assess the absorption of 20 mg Lefradafiban in two formulations, each under physiological conditions and with 40 mg Pantoprazole


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
* Age ≥ 18 and ≤ 60 years, planned stratification: age \< 40 years (4 subjects) and ≥ 40 years (8 subjects)
* Broca ≥ - 20 % and ≤ + 20 %

Exclusion Criteria:

* Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
* Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration
* Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
* Drug abuse
* Alcohol abuse (\> 60 g/day)
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
* Excessive physical activities within 5 days prior to administration or during the trial
* Blood donation within 1 month prior to administration or during the trial
* History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal disorders
* Chronic or relevant acute infections
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* History of

  * Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  * Any bleeding disorder including prolonged or habitual bleeding
  * Other hematologic disease
  * Cerebral bleeding (e.g. after a car accident)
* Recent surgical procedures
* Thrombocytes \< 150000/µ
* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Any laboratory value outside the clinically accepted reference range
* Other disease or abnormality of clinical relevance

Primary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma at steady state, 13th dosing interval (AUCss,13)
timeFrame: Up to 168 hours after first drug administration
measure: Maximum concentration of the analyte in plasma at steady state, 13th dosing interval (Cmax,ss,13)
timeFrame: Up to 168 hours after first drug administration
measure: Pre-dose concentration of the analyte in plasma at steady state, 13th dosing interval (Cpre,ss,13)
timeFrame: Up to 168 hours after first drug administration
measure: Amount of the analyte eliminated unchanged in the urine per dosing interval (Ae% (i=1,...,13))
timeFrame: Up to 168 hours after first drug administration
Secondary outcomes:
measure: Pre-dose concentration lf the analyte in plasma for the i-th dosing interval (Cpre,i (i=1,4,7,10,11,12))
timeFrame: Up to 168 hours after first drug administration
measure: Plasma concentration of the analyte at 2 hours post-dose for the i-th dosing interval (C2h,i (i=10,11,12))
timeFrame: up to 2 hours after each dosing interval
measure: Terminal half life of the analyte in plasma (t1/2)
timeFrame: Up to 168 hours after first drug administration
measure: Percent swing of peak/trough concentrations of the analyte in plasma for the i-th dosing interval (%Swing,i)
timeFrame: Up to 168 hours after first drug administration
measure: Percent peak-trough fluctuation for the 13th dosing interval (%PTF13)
timeFrame: Up to 168 hours after first drug administration
measure: Percent fluctuation of area under the plasma concentration-time curve (AUCfluc,13)
timeFrame: Up to 168 hours after first drug administration
measure: Fibrinogen receptor occupancy levels
timeFrame: Up to 168 hours after first drug administration
measure: Number of subjects with adverse events
timeFrame: Up to 3 days after last drug administration
measure: Number of subjects with clinically significant findings in vital signs
timeFrame: Up to 3 days after last drug administration
measure: Number of subjects with clinically significant findings in laboratory tests
timeFrame: Up to 3 days after last drug administration
Other outcomes:
Locations:
Study officials:
References: