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

NCT02171039 | Completed Phase 1

• 1 other identifier: 1160.58
• 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 atorvastatin and the bioavailability of atorvastatin 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 one dosing interval ( AUCτ,ss)

  Day 4

• Maximum 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 (23)

• 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 day 7 after administration

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

  Up to day 7 after administration

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

  Up to day 7 after administration

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

  Up to day 7 after administration

• Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)

  2 hours before and 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours after drug administration

Study Arms (3)

dabigatran plus atorvastatin

EXPERIMENTAL

Drug: Dabigatran; Drug: Atorvastatin

dabigatran

ACTIVE COMPARATOR

Drug: Dabigatran

atorvastatin

ACTIVE COMPARATOR

Drug: Atorvastatin

Interventions

Dabigatran DRUG

dabigatran; dabigatran plus atorvastatin

Atorvastatin DRUG

atorvastatin; dabigatran plus atorvastatin

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)
• Liver transaminases (ALT; aspartate aminotransferase (AST); GGT) and creatin kinase (CK) are to be within the normal range
• Haemoglobin values within the normal range
• 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
• History or presence of acute liver disease
• History or presence of myopathy
• 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 drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
• Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days 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 Wort

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Dabigatran; Atorvastatin

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

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: August 31, 2018

Record last verified: 2018-08