Dabigatran in an Interaction Probe Drug Cocktail

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Turku University Hospital
• Treatments: Caffeine; Clarithromycin; Dabigatran; Diclofenac; Esomeprazole; Metoprolol; Midazolam

Criteria

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