Influence of Pantoprazole on the Pharmacokinetics of Fradafiban After Multiple Oral Doses of Lefradafiban Over 5 Days in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Lefradafiban tablet; Drug: Lefradafiban double chamber sachet; Drug: Pantoprazole

• Registration Number: NCT02264106
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To assess the absorption of 30 mg Lefradafiban in two formulations, each under physiological conditions and with 40 mg Pantoprazole

Detailed Description

Not available

Study Timeline

• Study Start: 1998-04
• Primary Completion: 1998-06
• Status Verified: 2014-10
• Study First Submitted: 2014-10-13
• Study First Submitted QC: 2014-10-13
• Last Update Submitted: 2014-10-13
• Study First Posted: 2014-10-15
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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 %

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lefradafiban tablet with pantoprazole	Lefradafiban tablet	-
Lefradafiban double chamber sachet	Lefradafiban double chamber sachet	-
Lefradafiban tablet with pantoprazole	Pantoprazole	-
Lefradafiban double chamber sachet with pantoprazole	Lefradafiban double chamber sachet	-
Lefradafiban tablet	Lefradafiban tablet	-
Lefradafiban double chamber sachet with pantoprazole	Pantoprazole	-

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of the analyte in plasma at steady state, 13th dosing interval (AUCss,13)	Up to 168 hours after first drug administration
Amount of the analyte eliminated unchanged in the urine per dosing interval i expressed as percent of applied dose and corrected for molecular weight differences (Ae% (i=1,...,13))	Up to 168 hours after first drug administration
Maximum concentration of the analyte in plasma at steady state, 13th dosing interval (Cmax,ss,13)	Up to 168 hours after first drug administration
Pre-dose concentration of the analyte in plasma at steady state, 13th dosing interval (Cpre,ss,13)	Up to 168 hours after first drug administration

Secondary Outcome Measures

Name	Time	Method
Pre-dose concentration of the analyte in plasma for the i-th dosing interval (Cpre,i (i=1,4,7,10,11,12))	Up to 90 hours after first drug administration
Plasma concentration of the analyte at 2 hours post-dose for the i-th dosing interval (C2h,i (i=10,11,12))	Up to 98 hours after first drug administration
Percent swing of peak/trough concentrations of the analyte in plasma for the i-th dosing interval (%Swingi)	Up to 168 hours after first drug administration	Calculated: (C2h,i - Cpre,i) / Cpre,i \* 100% (i=10,11,12)
Terminal half life of the analyte in plasma (t1/2)	Up to 168 hours after first drug administration
Percent peak-trough fluctuation for the 13th dosing interval (%PTF13)	Up to 168 hours after first drug administration	Calculated: (Cmax,ss,13 - Cpre,ss,13) \* 8h / AUCss,13 \* 100%)
Number of patients with clinically relevant findings in laboratory tests	up to 168 hours after first drug administration
Fibrinogen receptor occupancy levels	Up to 168 hours after first drug administration
Number of patients with clinically relevant findings in vital signs	up to day 8 after first drug administration	systolic and diastolic blood pressure, pulse rate
Number of patients with adverse events	Up to 3 days after last drug administration
Percent fluctuation of area under the plasma concentration-time curve (AUCfluc,13)	Up to 168 hours after first drug administration	Calculated: (AUCabove,13 - AUCbelow,13) / AUCabove,13