Relative Bioavailability of Dabigatran and Digoxin in Healthy Male and Female Volunteers

NCT02171052 | Completed Phase 1

• 1 other identifier: 1160.59
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate the bioavailability of dabigatran with and without concomitant administration of digoxin and the bioavailability of digoxin with and without concomitant administration of dabigatran etexilate

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)

  Up to 72 hours after drug administration on day 4

• Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss)

  2 hours before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours after drug administration on day 4

Secondary Outcomes (22)

• Area under the concentration-time curve of the analyte in plasma from the time point 0 after the last dose at steady state to the last quantifiable analyte plasma concentration within the uniform dosing interval τ (AUC0-tz,ss)

  Up to 72 hours after drug administration on day 4

• Time of last measurable concentration of the analyte in plasma within the dosing interval τ at steady state (tz,ss)

  Up to 72 hours after drug administration on day 4

• Time from last dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)

  Up to 72 hours after drug administration on day 4

• Apparent clearance of the analyte in the plasma at steady state after extravascular multiple dose administration (CL/Fss)

  Up to 72 hours after drug administration on day 4

• Renal clearance of the analyte at steady state determined over the dosing interval τ (CLR,ss)

  Up to 24 hours after drug administration on day 4

Study Arms (3)

Dabigatran etexilate plus digoxin

EXPERIMENTAL

Drug: Dabigatran etexilate; Drug: Digoxin

Dabigatran etexilate

ACTIVE COMPARATOR

Drug: Dabigatran etexilate

Digoxin

ACTIVE COMPARATOR

Drug: Digoxin

Interventions

Dabigatran etexilate DRUG

Dabigatran etexilate; Dabigatran etexilate plus digoxin

Digoxin DRUG

Dabigatran etexilate plus digoxin; Digoxin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males and females according to the following criteria:
• Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
• Age ≥18 and ≤65 years
• BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.

You may not qualify if:

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Relevant surgery of gastrointestinal tract
• History of any bleeding disorder or acute blood coagulation defect
• Puls below 50 bpm at screening
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Intake of any medication within four weeks of first dosing.
• Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within four weeks prior to administration or during the trial
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Alcohol abuse (more than 60 g/day)
• Drug abuse
• Within 5 days of study medication no intake of grapefruit, grapefruit juice, or products containing grapefruit juice, Seville oranges, garlic supplements, or St. John's Worth
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Dabigatran; Digoxin

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 23, 2014
• Study Start: June 1, 2006
• Primary Completion: August 1, 2006
• Last Updated: June 23, 2014

Record last verified: 2014-06