Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor and Assessment of Ticagrelor Interaction Potential With Dabigatran

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01595854

First received: May 9, 2012

Last updated: November 14, 2012

Last verified: November 2012

Purpose

Evaluation of potential ticagrelor effects on dabigatran exposure and evaluation of two new pharmacodynamic methods

Condition	Intervention	Phase
Healthy	Drug: dabigatran etexilate Drug: Ticagrelor	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor (Part 1 and 2, Open, Non-randomised, 2 Parallel Groups) and Assessment of Ticagrelor Interaction Potential With Dabigatran (Part 3, Open, Randomised, Two-period Cross-over) in Healthy Male Subjects

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions

Drug Information available for: Dabigatran Dabigatran etexilate Ticagrelor Dabigatran etexilate mesylate

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

AUC of total dabigatran [Area under the concentration time curve] [ Time Frame: up to 48 hours ] [ Designated as safety issue: No ]
Cmax of total dabigatran [maximum measured concentration] [ Time Frame: up to 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of participants with clinically relevant findings in vital signs [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
Number of participants with clinically relevant changes in electrocardiogram results [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
Number of participants with clinically relevant changes from baseline laboratory measurements [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
Number of participants with adverse events [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]

Enrollment:	36
Study Start Date:	May 2012
Study Completion Date:	June 2012
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Test 2 (part 3) low dose dabigatran + high dose ticagrelor	Drug: Ticagrelor high dose ticagrelor Drug: dabigatran etexilate medium dose dabigatran
Active Comparator: Test 1 (part 1 + 2) high dose ticagrelor	Drug: Ticagrelor high dose ticagrelor
Experimental: Reference 1 (part 1 + 2) medium dose dabigatran	Drug: dabigatran etexilate medium dose dabigatran
Experimental: Reference 2 (part 3) low dose dabigatran	Drug: dabigatran etexilate low dose dabigatran

Eligibility

Criteria

Inclusion criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595854

Locations

Germany
1160.141.1 Boehringer Ingelheim Investigational Site
Biberach, Germany

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01595854 History of Changes
Other Study ID Numbers:	1160.141, 2012-000874-42
Study First Received:	May 9, 2012
Last Updated:	November 14, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Ticagrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013