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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02264119

509.119

Details and patient eligibility

About

Study to assess the absorption of 20 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)

---

12 participants in 4 patient groups

Lefradafiban tablet with Pantoprazole

Experimental group

Treatment:

Drug: Lefradafiban tablet

Drug: Pantoprazole tablet

Lefradafiban tablet without Pantoprazole

Active Comparator group

Treatment:

Drug: Lefradafiban tablet

Lefradafiban double chamber sachet with Pantoprazole

Experimental group

Treatment:

Device: Lefradafiban double chamber sachet

Drug: Pantoprazole tablet

Lefradafiban double chamber sachet without Pantoprazole

Active Comparator group

Treatment:

Device: Lefradafiban double chamber sachet