Relative Bioavailability of Single Oral Doses of Dabigatran Etexilate With or Without Oral Administration of Verapamil in Two Different Dosages in Healthy Male and Female Volunteers

NCT02171533 | Completed Phase 1

• 1 other identifier: 1160.74
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate whether and to what extent the P-glycoprotein inhibitor (P-gp) verapamil affects the pharmacokinetic parameters of dabigatran with verapamil given at different dosages, in different formulations (immediate release (IR) and extended release (ER)), and in different intervals in relation to the dabigatran dose.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUC0-infinity (area under the concentration-time curve of total dabigatran over the time interval from 0 extrapolated to infinity)

  up to 107 hours

• Cmax (maximum measured concentration of total dabigatran)

  up to 107 hours

Secondary Outcomes (31)

• AUC0-infinity (area under the concentration-time curve of free dabigatran over the time interval from 0 extrapolated to infinity)

  up to 107 hours

• Cmax (maximum measured concentration of free dabigatran)

  up to 107 hours

• AUC0-infinity (area under the concentration-time curve of verapamil over the time interval from 0 extrapolated to infinity)

  up to 107 hours

• Cmax (maximum measured concentration of verapamil)

  up to 107 hours

• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)

  up to 107 hours

Study Arms (2)

Fixed sequence

EXPERIMENTAL

Treatments will be given in a fixed sequence

Drug: dabigatran; Drug: Verapamil

Crossover

EXPERIMENTAL

Treatments will be given in randomized sequences

Drug: dabigatran; Drug: Verapamil; Drug: Verapamil ER

Interventions

dabigatran DRUG

Crossover; Fixed sequence

Verapamil DRUG

Crossover; Fixed sequence

Verapamil ER DRUG

Crossover

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
• Age ≥18 and ≤55 years
• Body mass index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
• 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
• 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
• Pulse rate below 50 bpm and or systolic blood pressure \<90 mm Hg at screening. ECG: PR \>170 ms (Part 1), AV block ≥1st degree (Part 2) at screening
• 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, especially intake of medication, which influences the blood clotting, i.e., acetylsalicylic acid, cumarin etc.
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Smoker (more than 15 cigarettes or 3 cigars or 3 pipes per day)
• Alcohol abuse (more than 60 g/day for men and more than 40 g/day for women)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
• Excessive physical activities (within one week prior to administration or during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Dabigatran; Verapamil

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenethylamines; Ethylamines; Amines; Organic Chemicals

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 24, 2014
• Study Start: June 1, 2008
• Primary Completion: August 1, 2008
• Last Updated: June 24, 2014

Record last verified: 2014-06