Dabigatran in an Interaction Probe Drug Cocktail

Healthy Volunteers Clinical Trial

— D-cocktail  

Official title:

An Open-label Crossover Trial Assessing the Value of Dabigatran in a Drug Interaction Cocktail in Healthy Young Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361619
• Other study ID #: T162/2014
• Secondary ID: 2014-003628-38
• Status: Completed
• Phase: Phase 1
• Start date: February 2015
• Est. completion date: June 2017

Study information

• Verified date: August 2018
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Caffeine
probe
• Diclofenac
probe
• Esomeprazole
probe
• Metoprolol
probe
• Midazolam
probe
• Dabigatran
probe
• Clarithromycin
perpetrator

Locations

Country	Name	City	State
Finland	Teutori CPRU	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC of dabigatran in plasma	Exposure ratio for dabigatran in combination and dabigatran alone	24 h
Secondary	Number of subjects with adverse events		23 days