Dabigatran in an Interaction Probe Drug Cocktail

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-06-30

Brief Summary

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Four periods of oral dosing following overnight fasting (1. known metabolic probe drug cocktail consisting of caffeine, diclofenac, esomeprazole, metoprolol, midazolam; 2. dabigatran + cocktail; 3. dabigatran alone; 4. clarithromycin 3 days + cocktail + dabigatran). Blood samples collected for pharmacokinetics over 24 h. Washout between periods. Adverse events, haematology and clinical chemistry recorded.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Caffeine

Intervention Type DRUG

probe

Diclofenac

Intervention Type DRUG

probe

Esomeprazole

Intervention Type DRUG

probe

Metoprolol

Intervention Type DRUG

probe

Midazolam

Intervention Type DRUG

probe

Dabigatran

Intervention Type DRUG

probe

Clarithromycin

Intervention Type DRUG

perpetrator

Interventions

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Caffeine

probe

Intervention Type DRUG

Diclofenac

probe

Intervention Type DRUG

Esomeprazole

probe

Intervention Type DRUG

Metoprolol

probe

Intervention Type DRUG

Midazolam

probe

Intervention Type DRUG

Dabigatran

probe

Intervention Type DRUG

Clarithromycin

perpetrator

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy
* Weight at least 50 kg and body mass index 19 - 30 kg m-2
* Normal clinical laboratory profiles
* No childbearing potential or use of adequate contraceptive measures

Exclusion Criteria

* Blood loss \>300 ml within 2 months prior to the first dosing day
* Pregnancy, breastfeeding
* Allergy or hypersensitivity to caffeine, diclofenac, esomeprazole, metoprolol, midazolam, dabigatran or clarithromycin or to excipients in the pharmaceutical products
* Infection with HIV, HBV or HCV
* Participation in the preceding 3 months or concomitantly in any clinical drug study
* Suspected current drug or alcohol abuse
* History of drug or alcohol abuse.
* Concomitant medication with the exception of hormonal contraception.
* Positive result in urine test for drug abuse.
* Nicotine consumption equivalent to \>5 cigarettes per day

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes