Dabigatran in an Interaction Probe Drug Cocktail

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Caffeine; Drug: Diclofenac; Drug: Esomeprazole; Drug: Metoprolol; Drug: Midazolam; Drug: Dabigatran; Drug: Clarithromycin

• Registration Number: NCT02361619
• Lead Sponsor: Turku University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-30
• Study Start: 2015-02
• Study First Submitted QC: 2015-02-06
• Study First Posted: 2015-02-12
• Primary Completion: 2016-09
• Study Completion: 2017-06
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-10
• Last Update Posted: 2018-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Clarithromycin	-
1	Caffeine	-
1	Diclofenac	-
1	Dabigatran	-
1	Esomeprazole	-
1	Metoprolol	-
1	Midazolam	-

Primary Outcome Measures

Name	Time	Method
AUC of dabigatran in plasma	24 h	Exposure ratio for dabigatran in combination and dabigatran alone

Secondary Outcome Measures

Name	Time	Method
Number of subjects with adverse events	23 days

Trial Locations

Locations (1)

Teutori CPRU; 🇫🇮 Turku, Finland