Single and Multiple Oral Doses of Dabigatran Etexilate in Healthy Chinese Subjects

NCT02171572 | Completed Phase 1

• 1 other identifier: 1160.81
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of the current study is to investigate safety, tolerability and, pharmacokinetics of dabigatran etexilate following oral administration of single and multiple oral doses (110mg, 150 mg b.i.d., 7 days) in healthy Chinese subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Changes in physical examination

  Day 1 and 14

• Changes in vital signs

  Day 1 to 14

• Changes in 12-lead electrocardiogram (ECG)

  Day 1, Day 4-10, day 14

• Changes from baseline in laboratory examinations

  Day 1, 2, 4, 7, 11, 14

• Occurrence of adverse events

  up to 7 days after last drug intake

Secondary Outcomes (23)

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

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after single dose of study drug

• tmax (time from dosing to maximum measured concentration of the analyte in plasma)

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after single dose of study drug

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

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after single dose of study drug

• AUC 0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration)

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after single dose of study drug

• AUC0-∞ (amount of analyte that is eliminated in area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after single dose of study drug

Study Arms (2)

Dabigatran etexilate low

EXPERIMENTAL

Drug: Dabigatran etexilate low

Dabigatran etexilate high

EXPERIMENTAL

Drug: Dabigatran etexilate high

Interventions

Dabigatran etexilate low DRUG

Dabigatran etexilate low

Dabigatran etexilate high DRUG

Dabigatran etexilate high

Eligibility Criteria

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

You may qualify if:

• Healthy subjects according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR and body temperature), 12-lead ECG, clinical laboratory tests
• No finding of clinical relevance.
• No evidence of a clinically relevant concomitant disease.
• Age: ≥18 and ≤45 years.
• Body Mass Index (BMI): ≥18 and \<25 kg/m2.
• Signed and dated written informed consent prior to admission to the trial in accordance with Chinese GCP.

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 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 (NSAID), 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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: 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: October 1, 2009
• Primary Completion: November 1, 2009
• Last Updated: June 24, 2014

Record last verified: 2014-06