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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 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)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
A
cyclosporine 600 mg+ a single oral dose of 180 mg ticagrelor
Intervention: cyclosporine (Drug)
A
cyclosporine 600 mg+ a single oral dose of 180 mg ticagrelor
Intervention: ticagrelor (Drug)
B
single dose cyclosporine 600 mg
Intervention: cyclosporine (Drug)
C
single dose 180 mg ticagrelor
Intervention: ticagrelor (Drug)
Outcomes
Primary Outcomes
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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- 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)