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

Study Overview
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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.

Official Title
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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

Intervention / Treatment
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* Drug: cyclosporine
* Drug: ticagrelor


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>cyclosporine 600 mg+ a single oral dose of 180 mg ticagrelor | Drug: cyclosporine<br>* Oral tablets, 600 mg , single dose<br>Drug: ticagrelor<br>* Oral tablets, 180 mg, single dose<br>|
| Experimental: B<br>single dose cyclosporine 600 mg | Drug: cyclosporine<br>* Oral tablets, 600 mg , single dose<br>|
| Experimental: C<br>single dose 180 mg ticagrelor | Drug: ticagrelor<br>* Oral tablets, 180 mg, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the pharmacokinetic (PK) profile for Ticagrelor and its metabolite AR-C124910XX in terms of maximum concentration (Cmax),time to maximum concentration (tmax) and area under the concentration curve from time zero to infinity (AUC) | PK samples will be collected postdose at visits 2,3 and 4 | PK samples will be collected postdose 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours | 
| Description of the PK profile for Ticagrelor and its metabolite AR-C124910XX in terms of area under the concentration-time curve from time zero to the last measurable concentration (AUC(0-t)),terminal half-life (t1/2) | PK samples will be collected postdose at visit 2,3 and 4 | PK samples will be collected postdose 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours | 
| Description of the PK profile for AR-C124910XX : ticagrelor in terms of ratios for Cmax, AUC(0-t), and AUC | PK samples will be collected postdose at visit 2,3 and 4 | PK samples will be collected postdose 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours | 
| Description of the PK profile for Cyclosporine in terms of Cmax, AUC(0-t), AUC, tmax and t1/2 | PK samples will be collected postdose at visit 2,3 and 4 | PK samples will be collected postdose 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the safety profile in terms of adverse events, blood pressure, pulse, temperature, ECG (Electrocardiogram), physical examination, and safety laboratory variables |  | Baseline up to 45 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, Healthy male volunteers, pharmacokinetics, cyclosporine, ticagrelor, Bioavailability (plasma AUC, Cmax, plasma AUC0-t, t1/2λz, tmax)