Pharmacokinetics, Safety and Pharmacodynamics After Multiple Oral Doses of Dabigatran Etexilate Capsule in Healthy Japanese and Caucasian Male Subjects

NCT02171468 | Completed Phase 1

• 1 other identifier: 1160.61
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate and compare pharmacokinetics, safety and pharmacodynamics of dabigatran etexilate following oral administration of multiple doses (110 mg and 150 mg b.i.d., 7 days) in healthy male subjects between Japanese and Caucasians

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Occurrence of adverse events

  up to 10 days

• Changes in QT(c) intervals

  up to 7 days

• Cmax,ss (maximum measured concentration of the analyte in plasma at steady state)

  up to 7 days

• AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)

  up to 7 days

Secondary Outcomes (16)

• Cmax (maximum measured concentration)

  day 1

• tmax (time from dosing to maximum measured concentration)

  day 1

• AUCτ,1 (area under the concentration-time curve over a uniform dosing interval τ after administration of single dose on Day 1)

  day 1

• tmax,ss (time from last dosing to maximum concentration at steady state)

  up to 7 days

• Cmin,ss (minimum concentration at steady state over a uniform dosing interval τ)

  up to 7 days

Study Arms (2)

Dabigatran high dose

EXPERIMENTAL

Drug: Dabigatran high dose

Dabigatran low dose

EXPERIMENTAL

Drug: Dabigatran low dose

Interventions

Dabigatran high dose DRUG

Dabigatran high dose

Dabigatran low dose DRUG

Dabigatran low dose

Eligibility Criteria

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

You may qualify if:

• Japanese or Caucasian 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 electrocardiogram, clinical laboratory tests
• No finding of clinical relevance
• No evidence of a clinically relevant concomitant disease
• Caucasian subjects are from a well-defined Caucasian population, both parents of Caucasians, the subjects can understand the subject information for informed consent in English and the subjects have lived 8 or less than 8 years in Japan
• Age: ≥20 and ≤45 years
• Body mass index (BMI): ≥18.5 and ≤29.9 kg/m2
• Signed and dated written informed consent before admission to the trial site

You may not qualify if:

• Current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Subject can not use an adequate form of contraception from the time of the first dose on Day 1 up to 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 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 is shorter, of the respective drug prior to administration or during the trial
• Use of aspirin (including over-the-counter medications), antipletelet agents like ticlopidine or dipyridamole, chronic administration of nonsteroidal antiinflammatory drugs , coumadin like anticoagulants, chronic use of corticosteroids, heparin or fibrinolytic agents within 28 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: 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 24, 2014
• Study Start: May 1, 2006
• Primary Completion: July 1, 2006
• Last Updated: June 24, 2014

Record last verified: 2014-06