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Study to Assess Effect of Cyclosporine on the Blood Levels of Ticagrelor

NCT ID: NCT01504906

Last Updated: 2012-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-06-30

Brief Summary

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The purpose of this study is to assess the effect of Cyclosporine on the blood levels of Ticagrelor.

Detailed Description

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A Single-Center,Open-Label,Randomized,3-Treatment,3-Period Cross-Over Study to Investigate the Potential Effect of Cyclosporine on the Pharmacokinetics, Safety, and Tolerability of Ticagrelor and the Effect of Ticagrelor on the Pharmacokinetics, Safety, and Tolerability of Cyclosporine.

Conditions

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Healthy

Keywords

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Phase 1 Healthy male volunteers pharmacokinetics cyclosporine ticagrelor Bioavailability (plasma AUC, Cmax, plasma AUC0-t, t1/2λz, tmax)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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A

cyclosporine 600 mg+ a single oral dose of 180 mg ticagrelor

Group Type EXPERIMENTAL

cyclosporine

Intervention Type DRUG

Oral tablets, 600 mg , single dose

ticagrelor

Intervention Type DRUG

Oral tablets, 180 mg, single dose

B

single dose cyclosporine 600 mg

Group Type EXPERIMENTAL

cyclosporine

Intervention Type DRUG

Oral tablets, 600 mg , single dose

C

single dose 180 mg ticagrelor

Group Type EXPERIMENTAL

ticagrelor

Intervention Type DRUG

Oral tablets, 180 mg, single dose

Interventions

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cyclosporine

Oral tablets, 600 mg , single dose

Intervention Type DRUG

ticagrelor

Oral tablets, 180 mg, single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of signed and dated written informed consent prior to any study-specific procedures
* Healthy male subjects aged 18 to 45 years (inclusive) with suitable veins for cannulation or repeated venipuncture

Exclusion Criteria

* History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
* A history of hemophilia, von Willebrand's disease, lupus anti-coagulant, or other diseases/syndromes that can either alter or increase the propensity for bleeding
* A personal history of vascular abnormalities including aneurysms; a personal history of severe hemorrhage, hematemesis, melena, hemoptysis, severe epistaxis, severe thrombocytopenia, intracranial hemorrhage, or rectal bleeding within 1 year
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Miriana Kujacic, MD

Role: STUDY_CHAIR

Molndal, Sweden AstraZeneca

Kelli Craven, MD

Role: PRINCIPAL_INVESTIGATOR

Overland Park US, Quintiles, Inc.

Locations

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Research site

Overland Park, Kansas, United States

Site Status

Countries

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United States

References

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Teng R, Kujacic M, Hsia J. Pharmacokinetic interaction study of ticagrelor and cyclosporine in healthy volunteers. Clin Drug Investig. 2014 Aug;34(8):529-36. doi: 10.1007/s40261-014-0205-2.

Reference Type DERIVED
PMID: 24861133 (View on PubMed)

Other Identifiers

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D5130C00074

Identifier Type: -

Identifier Source: org_study_id