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Trial record 31 of 333 for:    DABIGATRAN

Relative Bioavailability of Single Doses of Dabigatran Etexilate When Administered Alone or in Combination With a Single Dose of Ketoconazole or in Combination With q.d. Ketoconazole at Steady State in Healthy Male and Female Volunteers

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ClinicalTrials.gov Identifier: NCT02170675
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : June 23, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To investigate whether and to what extent the P-glycoprotein (P-gp) inhibitor ketoconazole affects plasma exposure of dabigatran.

Condition or disease Intervention/treatment Phase
Healthy Drug: Dabigatran etexilate Drug: Ketoconazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Bioavailability of Single Doses of 150 mg Dabigatran Etexilate (Capsule) When Administered Alone or in Combination With a Single Dose of 400 mg Ketoconazole (Tablet) or in Combination With 400 mg q.d. Ketoconazole (Tablet) at Steady State in Healthy Male and Female Volunteers (an Open Label, Fixed Sequence, Phase I Study)
Study Start Date : June 2009
Actual Primary Completion Date : July 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dabigatran etexilate + Ketoconazole

Period 1 - Dabigatran etexilate

Period 2 - Dabigatran etexilate and single dose of 400 mg Ketoconazole on Day 8 and 9

Period 3 - Dabigatran etexilate and multiple doses of 400 mg Ketoconazole on Day 10 to 16

Drug: Dabigatran etexilate
Drug: Ketoconazole



Primary Outcome Measures :
  1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for total dabigatran [ Time Frame: up to Day 16 ]
  2. Maximum measured concentration of the analyte in plasma for total dabigatran [ Time Frame: up to Day 16 ]

Secondary Outcome Measures :
  1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for free dabigatran [ Time Frame: up to Day 16 ]
  2. Maximum measured concentration of the analyte in plasma for free dabigatran [ Time Frame: up to Day 16 ]
  3. Maximum measured concentration of the analyte in plasma for dabigatran and BIBR 1087 SE, BIBR 951 BS [ Time Frame: up to Day 16 ]
  4. Time from dosing to the maximum concentration of the analyte in plasma for dabigatran and BIBR 1087 SE, BIBR 951 BS [ Time Frame: up to Day 16 ]
  5. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point for dabigatran [ Time Frame: up to Day 16 ]
    Dabigatran after each single dose (free and total after conjugate cleavage)

  6. Area under the concentration-time curve of the analyte in plasma over the time interval from timepoints t1 to t2 for dabigatran [ Time Frame: up to Day 16 ]
    Dabigatran after each single dose (free and total after conjugate cleavage)

  7. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 h for dabigatran [ Time Frame: up to Day 16 ]
    Dabigatran after each single dose (free and total after conjugate cleavage)

  8. Time from dosing to the maximum concentration of the analyte in plasma for dabigatran [ Time Frame: up to Day 16 ]
    Dabigatran after each single dose (free and total after conjugate cleavage)

  9. Terminal rate constant of the analyte in plasma for dabigatran [ Time Frame: up to Day 16 ]
    Dabigatran after each single dose (free and total after conjugate cleavage)

  10. Terminal half-life of the analyte in plasma for dabigatran [ Time Frame: up to Day 16 ]
    Dabigatran after each single dose (free and total after conjugate cleavage)

  11. Mean residence time of the analyte in the body after oral administration for dabigatran [ Time Frame: up to Day 16 ]
    Dabigatran after each single dose (free and total after conjugate cleavage)

  12. Apparent clearance of the analyte in the plasma after extravascular administration for dabigatran [ Time Frame: up to Day 16 ]
    Dabigatran after each single dose (free and total after conjugate cleavage)

  13. Apparent volume of distribution during the terminal phase λz following an extravascular dose for dabigatran [ Time Frame: up to Day 16 ]
    Dabigatran after each single dose (free and total after conjugate cleavage)

  14. Changes from baseline in Vital signs (blood pressure [BP], pulse rate) [ Time Frame: up to 14 days after last drug administration ]
  15. Changes from baseline in 12-lead ECG [ Time Frame: up to 14 days after last drug administration ]
  16. Changes from baseline in Clinical laboratory tests (haematology, clinical chemistry, and urinalysis) [ Time Frame: up to 14 days after last drug administration ]
  17. Number of patients with adverse events [ Time Frame: up to 14 days after last drug administration ]
  18. Assessment of tolerability by the investigator [ Time Frame: up to 14 days after last drug administration ]


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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy males and females according to the following criteria:

    Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests

  2. Age ≥21 and ≤50 years
  3. BMI range ≥18.5 and ≤29.9 kg/m2 (Body Mass Index)
  4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.

Exclusion Criteria:

  1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
  2. Any evidence of a clinically relevant concomitant disease
  3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  4. Surgery of the gastrointestinal tract (except appendectomy)
  5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  6. History of relevant orthostatic hypotension, fainting spells or blackouts.
  7. Chronic or relevant acute infections
  8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  9. 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, and intake of drugs which might reasonably influence the results of the trial within four weeks prior to administration or during the trial (e.g. P-gp inducers)
  10. Participation in another trial with an investigational drug within two months prior to administration or during the trial
  11. Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
  12. Alcohol abuse (more than 60 g/day)
  13. Drug abuse
  14. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  15. Excessive physical activities (within one week prior to administration or during the trial)
  16. Any laboratory value outside the reference range that was of clinical relevance
  17. Inability to comply with dietary regimen of trial site

    Exclusion criteria that were specific for this study:

  18. Intake of medication, which influences the blood clotting, such as acetylsalicylic acid and oral vitamin K antagonists

    For female subjects:

  19. Pregnancy / positive pregnancy test, or planning to become pregnant during the study or within 1 month of study completion
  20. No adequate contraception during the study and until 1 month of study completion, i.e.

    implants, injectables, combined oral contraceptives, IUD [intrauterine device], sexual abstinence (for at least 1 month prior to enrolment), or surgical sterilisation (incl.

    hysterectomy). Females, who were not surgically sterile were asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)

  21. Lactation period

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02170675     History of Changes
Other Study ID Numbers: 1160.101
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Dabigatran
Ketoconazole
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors