Safety, Pharmacokinetics and Pharmacodynamics of BIBR 1048 MS Capsule in Healthy Male Subjects of Japanese and Caucasian Origin

NCT02170909 | Completed Phase 1

• 1 other identifier: 1160.29
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate and compare safety, pharmacokinetics and pharmacodynamics of BIBR 1048 MS following oral administration of single (150 mg, 220 mg and 300 mg) and multiple (150 mg and 220 mg q.d. and 150 mg b.i.d.) rising doses in healthy male subjects of Japanese and Caucasian origin.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Change in vital signs

  Baseline and up to day 26

• Change in 12-lead electrocardiogram (ECG)

  Baseline and up to day 26

• Change in clinical laboratory tests

  Baseline and up to day 26

• Occurence of adverse events

  Up to day 26

Secondary Outcomes (36)

• Area under the curve (AUC) from 0-24 hours for activated partial thromboplastin time (aPTT)

  Day 1 and 12

• AUC from 0-24 hours for ecarin clotting time (ECT)

  Day 1 and 12

• Change in thrombin time (TT)

  Baseline and up to 72 hours after administration on day 1 and 12

• Change in prothrombin time (PT) expressed as international normalised ratio (INR)

  Baseline and up to 72 hours after administration on day 1 and 12

• Maximum value of aPTT

  Up to 72 hours after administration on day 1 and 12

Study Arms (3)

BIBR 1048 MS low dose

EXPERIMENTAL

Drug: BIBR 1048 MS low dose

BIBR 1048 MS medium dose

EXPERIMENTAL

Drug: BIBR 1048 MS medium dose

BIBR 1048 MS high dose

EXPERIMENTAL

Drug: BIBR 1048 MS high dose

Interventions

BIBR 1048 MS low dose DRUG

BIBR 1048 MS low dose

BIBR 1048 MS medium dose DRUG

BIBR 1048 MS medium dose

BIBR 1048 MS high dose DRUG

BIBR 1048 MS high dose

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects of Japanese or Caucasian origin according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate, respiratory rate and tympanic body temperature), 12- lead ECG (electrocardiogram), clinical laboratory tests
• No finding deviating from normal and of clinical relevance
• No evidence of a clinically relevant concomitant disease
• Age ≥ 20 and Age ≤ 45 years
• Body mass index (BMI) ≥ 18 and ≤ 25 kg/m2
• Japanese subjects were from a well-defined Japanese population, both parents of Japanese origin and the subjects have Japanese passport and had lived ≤ 8 years outside Japan.
• Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation.

You may not qualify if:

• Current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• An unwillingness of male subjects to abstain from sexual intercourse with pregnant or lactating women, or an unwillingness of male subjects to use an adequate form of contraception as well as having their female partner(s) use another form of contraception (if the woman possibly become pregnant) from the time of the single dose on Day 1 until Day 22-26 (end-of study examination)
• Current diseases of the central nervous system (such as epilepsy), or psychiatric disorders or neurological disorders
• History of clinically significant orthostatic hypotension, clinically significant current or past fainting spells or blackouts
• 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)
• concussions (head trauma resulting in injuring to brain) with or without loss of consciousness
• Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives, whichever is shorter, of the respective drug prior to administration or during the trial
• Use of acetylsalicylic acid (ASA)-containing over-the-counter medications, clopidogrel or ticlopidine or dipyridamole, chronic administration of non-steroidal anti-inflammatory drugs (NSAIDs) (cyclooxygenase-2 (COX-2) inhibitors excluded), coumadin like anticoagulants, chronic use of corticosteroids, heparin and fibrinolytic agents within 14 days prior to administration or during the trial.
• Participation in another trial with an investigational drug within three months prior to administration or during the trial
• Smoker (\> 10 cigarettes/day or \> 3 cigars/day or \> 3 pipes/day)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 23, 2014
• Study Start: December 1, 2004
• Primary Completion: June 1, 2005
• Last Updated: August 31, 2018

Record last verified: 2018-08