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OpenTrials
Completed

NCT Number: NCT02361619

Dabigatran in an Interaction Probe Drug Cocktail

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.

Completed

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Teutori CPRU

Turku, 20520, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caffeine

Drug

probe

Diclofenac

Drug

probe

Esomeprazole

Drug

probe

metoprolol

Drug

probe

midazolam

Drug

probe

dabigatran

Drug

probe

Clarithromycin

Drug

perpetrator

Primary outcomes

  1. AUC of dabigatran in plasma

    Time frame: 24 h

    Exposure ratio for dabigatran in combination and dabigatran alone

Secondary outcomes

  1. Number of subjects with adverse events

    Time frame: 23 days

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Official study title

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

Acronym: D-cocktail

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Feb 12, 2015
Registry last updated
Aug 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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