Dabigatran in an Interaction Probe Drug Cocktail

NCT02361619 | Completed Phase 1

• 2 other identifiers: T162/20142014-003628-38
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• AUC of dabigatran in plasma

  Exposure ratio for dabigatran in combination and dabigatran alone

  24 h

Secondary Outcomes (1)

• Number of subjects with adverse events

  23 days

Study Arms (1)

1

EXPERIMENTAL

Drug: Caffeine; Drug: Diclofenac; Drug: Esomeprazole; Drug: Metoprolol; Drug: Midazolam; Drug: Dabigatran; Drug: Clarithromycin

Interventions

Caffeine DRUG

probe

1

Diclofenac DRUG

probe

1

Esomeprazole DRUG

probe

1

Metoprolol DRUG

probe

1

Midazolam DRUG

probe

1

Dabigatran DRUG

probe

1

Clarithromycin DRUG

perpetrator

1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Teutori CPRU

Turku, 20520, Finland

Location

MeSH Terms

Interventions

Caffeine; Diclofenac; Esomeprazole; Metoprolol; Midazolam; Dabigatran; Clarithromycin

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Benzodiazepines; Benzazepines; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Petri Vainio, MD PhD

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2015
• First Posted: February 12, 2015
• Study Start: February 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: June 1, 2017
• Last Updated: August 14, 2018

Record last verified: 2018-08

Locations

FI (1)