Multiple Oral Doses of BIBR 1048 MS Solution in Healthy Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BIBR 1048 MS medium 2; Drug: BIBR 1048 MS medium 1; Drug: BIBR 1048 MS placebo; Drug: BIBR 1048 MS high; Drug: BIBR 1048 MS low

Study type: Interventional

Funder types: Industry

Identifiers

NCT02170831

1160.2

Details and patient eligibility

About

To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters.

Enrollment: 40 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects as determined by results of screening
• Signed written informed consent in accordance with GCP and local legislation
• Age ≥ 18 and ≤ 45 years
• Broca ≥ -20% and ≤ +20%

Exclusion criteria

• Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance

• History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders

• History of orthostatic hypotension, fainting spells and blackouts

• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders

• Chronic or relevant acute infections

• 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)
  • commotio cerebri

• Intake of drugs with a long half-life (>24 hours) within 1 month prior to administration

• Use of any drugs which might influence the results of the trial within 10 days prior to administration or during trial

• Participation in another trial with an investigational drug within 2 months prior to administration or during trial

• Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days

• Alcohol abuse (> 60 g/day)

• Drug abuse

• Blood donation within 1 month prior to administration or during the trial

• Excessive physical activities within 5 days prior to administration or during the trial

• Any laboratory value outside the clinically accepted reference range

• History of any familial bleeding disorder

• Thrombocytes < 150000/µl

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 5 patient groups, including a placebo group

BIBR 1048 MS low dose

Experimental group

Treatment:

Drug: BIBR 1048 MS low

BIBR 1048 MS medium dose 1

Experimental group

Treatment:

Drug: BIBR 1048 MS medium 1

BIBR 1048 MS medium dose 2

Experimental group

Treatment:

Drug: BIBR 1048 MS medium 2

BIBR 1048 MS high dose

Experimental group

Treatment:

Drug: BIBR 1048 MS high

BIBR 1048 Placebo

Placebo Comparator group

Treatment:

Drug: BIBR 1048 MS placebo