Relative Bioavailability of Single Doses of Dabigatran Etexilate in Healthy Volunteers

NCT ID: NCT02173717

Last Updated: 2014-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30

Brief Summary

Study to investigate whether and to what extent the suggested P-glycoprotein (P-gp) inducer rifampicin affects plasma exposure of dabigatran.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dabigatran etexilate

Four treatments of 150 mg Dabigatran etexilate (single oral administration) in a fixed sequence.

1. Single oral administration of dabigatran etexilate on Day 1;

2. Oral administration of 600 mg rifampicin q.d. in the evening for 7 days (Days 2 to 8) followed by an oral morning dose of dabigatran etexilate on Day 9;

3. Single oral administration of dabigatran etexilate on Day 16, after 7 days of rifampicin washout;

4. Single oral administration of dabigatran etexilate on Day 23, after 14 days of rifampicin washout

Group Type: EXPERIMENTAL

Dabigatran etexilate

Intervention Type: DRUG

150 mg Dabigatran etexilate

Rifampicin

Intervention Type: DRUG

600 mg Rifampicin

Interventions

Dabigatran etexilate

150 mg Dabigatran etexilate

Intervention Type: DRUG

Rifampicin

600 mg Rifampicin

Intervention Type: DRUG

Other Intervention Names

Pradaxa®; BIBR 1048 MS; Rifa® 600

Eligibility Criteria

Inclusion Criteria

• Healthy male or female subjects according to the following criteria: based upon a complete medical history, including the physical examination, vital signs (BP, pulse rate), 12-lead ECG, clinical laboratory tests
• Age ≥18 and Age ≤45 years
• Body Mass Index (BMI) ≥18.5 and ≤29.9 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Exclusion Criteria

• Any gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
• Subjects who in the investigator's judgement were perceived as having an increased risk of bleeding, for example because of:

• Hemorrhagic disorders or bleeding diathesis
• Occult blood in faeces or haematocryal
• Trauma or surgery within the last month or as long as an excessive risk of bleeding persisted after these events, or planned surgery during trial participation
• History of arteriovenous malformation or aneurysm
• History of gastroduodenal ulcer disease, gastrointestinal haemorrhage, and haemorrhoids
• History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intraarticular bleeding
• Use of drugs that may have interfered with haemostasis during trial conduct (e.g. acetylic salicylic acid or other non-steroidal anti-inflammatory drugs)
• Relevant surgery of gastrointestinal tract
• 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 was deemed relevant to the trial as judged by the investigator
• Use of drugs which might have reasonably influenced the results of the trial based on the knowledge at the time of protocol preparation within four weeks prior to administration or during the trial, especially inhibitors or inducers of P-gp, CYP3A4, CYP2C9, or CYP2C19 trial (comment: CYP3A4 inhibitors are for example azole antimycotics, macrolides or grapefruit juice, CYP3A inducers are for example St. John's Wort or certain anticonvulsants)
• Intake of medication, which influences the blood clotting, i.e. acetylsalicylic acid, nonsteroidal anti-rheumatic drugs, cumarin, etc. within 14 days prior to screening or during the trial
• Participation in another trial with an investigational drug within one month prior to administration or during the trial
• Alcohol abuse (more than 60 g/day in males, more than 40 g/day in females)
• Drug abuse
• Blood donation (more than 100 mL within 4 weeks prior to administration)
• Any laboratory value outside the reference range that was of clinical relevance
• Inability to comply with dietary regimen of study centre
• Previous intake of rifampicin
• For female subjects:

• Pregnancy / positive pregnancy test, or planning to become pregnant during the study or within 1 month of study completion
• No adequate contraception in women of childbearing potential
• Lactation period

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1160.100

Identifier Type: -

Identifier Source: org_study_id