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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: cyclosporine; Drug: ticagrelor

Study type: Interventional

Funder types: Industry

Identifiers

NCT01504906

D5130C00074

Details and patient eligibility

About

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

Full description

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.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

A

Experimental group

Description:

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

Treatment:

Drug: ticagrelor

Drug: cyclosporine

B

Experimental group

Description:

single dose cyclosporine 600 mg

Treatment:

Drug: cyclosporine

C

Experimental group

Description:

single dose 180 mg ticagrelor

Treatment:

Drug: ticagrelor