Relative Bioavailability of Dabigatran and Atorvastatin in Healthy Male and Female Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Dabigatran; Drug: Atorvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02171039

1160.58

Details and patient eligibility

About

To investigate the bioavailability of dabigatran with and without concomitant administration of atorvastatin and the bioavailability of atorvastatin with and without concomitant administration of dabigatran etexilate

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 ≥18 and ≤65 years

3. BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)

4. Liver transaminases (ALT; aspartate aminotransferase (AST); GGT) and creatin kinase (CK) are to be within the normal range

5. Haemoglobin values within the normal range

6. Signed and dated written informed consent prior to admission to the study in accordance with GCP 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. History or presence of acute liver disease
5. History or presence of myopathy
6. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
7. History of relevant orthostatic hypotension, fainting spells or blackouts
8. Chronic or relevant acute infections
9. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
10. 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
11. 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
12. Participation in another trial with an investigational drug within two months prior to administration or during the trial
13. Alcohol abuse (more than 60 g/day)
14. Drug abuse
15. Within 5 days of study medication no intake of grapefruit, grapefruit juice, or products containing grapefruit juice, Seville oranges, garlic supplements, or St. John's Wort
16. Blood donation (more than 100 mL within four weeks prior to administration o during the trial)
17. Excessive physical activities (within one week prior to administration or during the trial)
18. Any laboratory value outside the reference range that is of clinical relevance
19. Inability to comply with dietary regimen of study centre
20. Females of child bearing potential who are pregnant, breast feeding or who are either not surgically sterile or are sexually active and not using an acceptable form of contraception as either the oral contraceptives since at least two months or the double barrier method, i.e. intrauterine device with spermicide and condom for the male partner
21. Male subjects will not agree to minimise the risk of female partners becoming pregnant from the first dosing day until 3 months after the completion of the post study medical. Acceptable methods of contraception comprises barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive since at least two month)
22. Planned surgeries within four weeks following the end-of study examination
23. Intake of medication, which influences the blood clotting, i.e., acetylsalicylic acid, cumarin etc.
24. The subject is not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
25. Vulnerable subjects (e.g. persons kept in detention).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

dabigatran plus atorvastatin

Experimental group

Treatment:

Drug: Atorvastatin

Drug: Dabigatran

dabigatran

Active Comparator group

Treatment:

Drug: Dabigatran

atorvastatin

Active Comparator group

Treatment:

Drug: Atorvastatin