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

• ClinicalTrials.gov Identifier: NCT02171455
• Recruitment Status: Completed
• First Posted: June 24, 2014
• Last Update Posted: June 24, 2014
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Study Description

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

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Dabigatran etexilate low dose; Drug: Dabigatran etexilate medium dose; Drug: Dabigatran etexilate high dose; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Safety, Pharmacodynamics and Pharmacokinetics After Single Oral Administration of 600 mg, 750 mg and 900 mg Dabigatran Etexilate as Capsule in Healthy Subjects. A Randomised, Placebo-controlled Study, Double Blind at Each Dose Level
• Study Start Date: January 2006
• Actual Primary Completion Date: January 2006

Arms and Interventions

Arm	Intervention/treatment
Experimental: Dabigatran etexilate low dose	Drug: Dabigatran etexilate low dose; Drug: Placebo
Experimental: Dabigatran etexilate medium dose	Drug: Dabigatran etexilate medium dose; Drug: Placebo
Experimental: Dabigatran etexilate high dose	Drug: Dabigatran etexilate high dose; Drug: Placebo

Outcome Measures

Primary Outcome Measures :

1. Frequency [N (%)] of subjects with adverse events [ Time Frame: up to 18 days ]

Secondary Outcome Measures :

1. Cmax (maximum measured concentration of free and total BIBR 953 ZW in plasma) [ Time Frame: up to 72 hours after administration ]
2. tmax (time from dosing to maximum measured concentration) [ Time Frame: up to 72 hours after administration ]
3. 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) [ Time Frame: up to 72 hours after administration ]
4. λz (terminal rate constant in plasma) [ Time Frame: up to 72 hours after administration ]
5. t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 72 hours after administration ]
6. MRTpo (mean residence time of the analyte in the body after oral administration) [ Time Frame: up to 72 hours after administration ]
7. CL/F (apparent clearance of the analyte in plasma after extravascular administration) [ Time Frame: up to 72 hours after administration ]
8. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: up to 72 hours after administration ]
9. Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) [ Time Frame: up to 72 hours after administration ]
10. fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) [ Time Frame: up to 72 hours after administration ]
11. CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) [ Time Frame: up to 72 hours after administration ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. 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
2. Age ≥18 and ≤55 years
3. Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
4. Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation.

Exclusion Criteria:

1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
2. Relevant surgery of gastrointestinal tract
3. History of any bleeding disorder or acute blood coagulation defect
4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
5. History of relevant orthostatic hypotension, fainting spells or blackouts
6. Chronic or relevant acute infections
7. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
8. 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
9. 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
10. Participation in another trial with an investigational drug within two months prior to administration or during the trial
11. Alcohol abuse (more than 60 g/day)
12. Drug abuse
13. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
14. Excessive physical activities (within one week prior to administration or during the trial)
15. Any laboratory value outside the reference range that is of clinical relevance
16. Inability to comply with dietary regimen of study centre

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02171455 History of Changes
• Other Study ID Numbers: 1160.60
• First Posted: June 24, 2014
• Last Update Posted: June 24, 2014
• Last Verified: June 2014

Additional relevant MeSH terms:

Dabigatran; Antithrombins; Serine Proteinase Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anticoagulants