Safety, Pharmacodynamics and Pharmacokinetics After Single Oral Administration of Dabigatran Etexilate Capsule in Healthy Subjects

NCT02171455 | Completed Phase 1

• 1 other identifier: 1160.60
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess safety, pharmacokinetics and the effect of dabigatran on coagulation parameters prior to administration of a high dose of dabigatran etexilate in a QT study

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Frequency [N (%)] of subjects with adverse events

  up to 18 days

Secondary Outcomes (11)

• Cmax (maximum measured concentration of free and total BIBR 953 ZW in plasma)

  up to 72 hours after administration

• tmax (time from dosing to maximum measured concentration)

  up to 72 hours after administration

• AUC0-∞ (area under the concentration-time curve of free and total BIBR 953 ZW in plasma over the time interval from 0 extrapolated to infinity)

  up to 72 hours after administration

• λz (terminal rate constant in plasma)

  up to 72 hours after administration

• t1/2 (terminal half-life of the analyte in plasma)

  up to 72 hours after administration

Study Arms (3)

Dabigatran etexilate low dose

EXPERIMENTAL

Drug: Dabigatran etexilate low dose; Drug: Placebo

Dabigatran etexilate medium dose

EXPERIMENTAL

Drug: Dabigatran etexilate medium dose; Drug: Placebo

Dabigatran etexilate high dose

EXPERIMENTAL

Drug: Dabigatran etexilate high dose; Drug: Placebo

Interventions

Dabigatran etexilate low dose DRUG

Dabigatran etexilate low dose

Dabigatran etexilate medium dose DRUG

Dabigatran etexilate medium dose

Dabigatran etexilate high dose DRUG

Dabigatran etexilate high dose

Placebo DRUG

Dabigatran etexilate high dose; Dabigatran etexilate low dose; Dabigatran etexilate medium dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
• Age ≥18 and ≤55 years
• Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
• 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:

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Relevant surgery of gastrointestinal tract
• History of any bleeding disorder or acute blood coagulation defect
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, 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
• Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
• Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Alcohol abuse (more than 60 g/day)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
• Excessive physical activities (within one week prior to administration or during the trial)
• Any laboratory value outside the reference range that is of clinical relevance

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: RANDOMIZED
• Masking: DOUBLE
• 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: January 1, 2006
• Primary Completion: January 1, 2006
• Last Updated: June 24, 2014

Record last verified: 2014-06