Safety, Pharmacokinetics and Pharmacodynamics After Multiple Oral Doses of BIBR 1048 MS Capsule in Healthy Japanese Male Subjects

NCT02171000 | Completed Phase 1

• 1 other identifier: 1160.55
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate safety, pharmacokinetics and pharmacodynamics of BIBR 1048 MS following oral administration of multiple doses (150 mg b.i.d., 7 days)

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Change from baseline in physical examination

  within 14 days prior to drug administration until up to 18 days post drug administration

• Change from baseline in vital signs

  within 14 days prior to drug administration until up to 18 days post drug administration

• Change from baseline in 12-lead electrocardiogram (ECG)

  within 14 days prior to drug administration until up to 18 days post drug administration

• Change from baseline in clinical laboratory tests

  within 14 days prior to drug administration until up to 18 days post drug administration

• Number of participants with adverse events

  within 14 days prior to drug administration until up to 18 days post drug administration

Secondary Outcomes (22)

• Changes in activated partial thromboplastin time (aPTT)

  Day 1 and 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 h after drug administration (morning), Day 2 to 6 prior drug administration (morning), Day 5 and 6 prior drug administration (evening), Day 7 24, 36, 48 h after final drug administration

• Changes in ecarin clotting time (ECT)

  Day 1 and 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 h after drug administration (morning), Day 2 to 6 prior drug administration (morning), Day 5 and 6 prior drug administration (evening), Day 7 24, 36, 48 h after final drug administration

• Changes in thrombin time (TT)

  Day 1 and 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 h after drug administration (morning), Day 2 to 6 prior drug administration (morning), Day 5 and 6 prior drug administration (evening), Day 7 24, 36, 48 h after final drug administration

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

  Day 1 and 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 h after drug administration (morning), Day 2 to 6 prior drug administration (morning), Day 5 and 6 prior drug administration (evening), Day 7 24, 36, 48 h after final drug administration

• Maximum measured concentration of the analyte in plasma (Cmax)

  Day 1 and 7 prior, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 h after drug administration (morning), Day 2 to 6 prior drug administration (morning), Day 5 and 6 prior drug administration (evening), Day 7 24, 36, 48 h after final drug administration

Study Arms (1)

BIBR 1048

EXPERIMENTAL

BIBR 1048 MS

Drug: BIBR 1048 MS

Interventions

BIBR 1048 MS DRUG

150 mg capsules, b.i.d, 7 days

Also known as: dabigatran etexilate

BIBR 1048

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects according to the following criteria:
• Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate and body temperature), 12-lead ECG, clinical laboratory tests
• No finding of clinical relevance
• No evidence of a clinically relevant concomitant disease
• Age ≥20 and Age ≤35 years
• Body Mass Index (BMI) ≥18 and BMI \<25 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the trial in accordance with Japanese GCP (Ministry of Health, Labour and Welfare Ordinance No.28, March 27, 1997).

You may not qualify if:

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Subject was not able to use an adequate form of contraception from the time of the first dose on Day 1 up to end-of study examination
• Diseases of the central nervous system (such as epilepsy), 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 was deemed relevant to the safety assessment as judged by the investigator (excluding asymptomatic seasonal rhinitis/hay fever)
• any bleeding disorder including prolonged or habitual bleeding
• other hematologic diseases
• 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 1 month or less than 10 half-lives, whichever was shorter, of the respective drug prior to administration or during the trial
• Use of aspirin (including over-the-counter medications), antiplatelet agents like ticlopidine or dipyridamole, chronic administration of non-steroidal anti-inflammatory drugs (NSAIDs, coumadin like anticoagulants, chronic use of corticosteroids, heparin or fibrinolytic agents within 14 days prior to administration up to end-of-study examination
• Participation in another trial with an investigational drug within 3 months prior to administration up to end-of-study examination
• Smoker (\>10 cigarettes/day or inability to refrain from smoking during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Dabigatran

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 23, 2014
• Study Start: April 1, 2005
• Primary Completion: May 1, 2005
• Last Updated: June 23, 2014

Record last verified: 2014-06