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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Pantoprazole; Drug: Lefradafiban tablet; Drug: Lefradafiban double chamber sachet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02264106

509.118

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

Lefradafiban tablet with pantoprazole

Experimental group

Treatment:

Drug: Pantoprazole

Drug: Lefradafiban tablet

Lefradafiban tablet

Active Comparator group

Treatment:

Drug: Lefradafiban tablet

Lefradafiban double chamber sachet with pantoprazole

Experimental group

Treatment:

Drug: Pantoprazole

Drug: Lefradafiban double chamber sachet

Lefradafiban double chamber sachet

Active Comparator group

Treatment:

Drug: Lefradafiban double chamber sachet