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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: cyclosporine; Drug: ticagrelor

• Registration Number: NCT01504906
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-02
• Study First Submitted QC: 2012-01-05
• Study First Posted: 2012-01-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-11
• Last Update Posted: 2012-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	cyclosporine	cyclosporine 600 mg+ a single oral dose of 180 mg ticagrelor
A	ticagrelor	cyclosporine 600 mg+ a single oral dose of 180 mg ticagrelor
B	cyclosporine	single dose cyclosporine 600 mg
C	ticagrelor	single dose 180 mg ticagrelor

Primary Outcome Measures

Name	Time	Method
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 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours	PK samples will be collected postdose at visits 2,3 and 4
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 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours	PK samples will be collected postdose at visit 2,3 and 4
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 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours	PK samples will be collected postdose at visit 2,3 and 4
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 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours	PK samples will be collected postdose at visit 2,3 and 4

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research site; 🇺🇸 Overland Park, Kansas, United States