Dabigatran in an Interaction Probe Drug Cocktail (D-cocktail)

Turku University Hospital (TYKS)

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Metoprolol

Drug: Caffeine

Drug: Midazolam

Drug: Diclofenac

Drug: Dabigatran

Drug: Clarithromycin

Drug: Esomeprazole

Study type

Interventional

Funder types

Other

Identifiers

NCT02361619

2014-003628-38 (EudraCT Number)

T162/2014

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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