Relative Bioavailability of Dabigatran Capsules, Pellets and Oral Solution in Healthy Volunteers

NCT02044367 | Completed Phase 1 Results

• 2 other identifiers: 1160.1942013-002498-23
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the relative bioavailability of dabigatran etexilate as pellets on food and of dabigatran etexilate as granules resolved in reconstitution solution, each with dabigatran etexilate as capsule following oral administration. To evaluate acceptability and palatability of Pellets sprinkled on food and Oral Liquid Formulation

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 t for Total Dabigatran.

  Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t for total dabigatran.

  47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration

• Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran.

  Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t for total dabigatran.

  47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration

Secondary Outcomes (4)

• Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.

  47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration

• Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.

  47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration

• Acceptability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.

  once on day 3 (48 hours after first dose)

• Palatability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.

  once on day 3 (48 hours after first dose)

Study Arms (3)

Test 1 (Treatment A)

EXPERIMENTAL

multiple dose of dabigatran

Drug: Dabigatran etexilate

Test 2 (Treatment B)

EXPERIMENTAL

multiple dose of dabigatran

Drug: Dabigatran etexilate

Reference

EXPERIMENTAL

multiple dose of dabigatran

Drug: Dabigatran etexilate

Interventions

Dabigatran etexilate DRUG

Pellets (multiple dose of dabigatran)

Test 1 (Treatment A)

Eligibility Criteria

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

You may qualify if:

• Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead electrocardiogram, and clinical laboratory tests
• Age 18 to 55 years (incl.)
• Body Mass Index 18.5 to 29.9 kg/m2 (incl.)
• Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

You may not qualify if:

• Any finding in the medical examination (including Blood Pressure, Pulse Rate or electrocardiogram) deviating from normal and judged clinically relevant by the investigator.
• Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease judged clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug
• Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
• Subjects who in the investigator's judgement are perceived as having an increased risk of bleeding, for example because of:
• Hemorrhagic disorders or bleeding diathesis
• Occult blood in faeces or haematuria
• Trauma or surgery within the last month or as long as an excessive risk of bleeding persists after these events, or planned surgery during trial participation
• History of arteriovenous malformation or aneurysm
• History of gastroduodenal ulcer disease or gastrointestinal haemorrhage
• History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intraarticular bleeding
• Anemia at screening

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1160.194.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

MeSH Terms

Interventions

Dabigatran

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

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: January 22, 2014
• First Posted: January 24, 2014
• Study Start: January 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 20, 2015
• Results First Posted: April 27, 2015

Record last verified: 2015-05

Locations

DE (1)