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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01504906
First received: January 2, 2012
Last updated: December 11, 2012
Last verified: December 2012
History of Changes

January 2, 2012
December 11, 2012
January 2012
June 2012   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    PK samples will be collected postdose at visit 2,3 and 4
Same as current
Complete list of historical versions of study NCT01504906 on ClinicalTrials.gov Archive Site
Description of the safety profile in terms of adverse events, blood pressure, pulse, temperature, ECG (Electrocardiogram), physical examination, and safety laboratory variables [ Time Frame: Baseline up to 45 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study to Assess Effect of Cyclosporine on the Blood Levels of Ticagrelor
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

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

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
  • Drug: cyclosporine
    Oral tablets, 600 mg , single dose
  • Drug: ticagrelor
    Oral tablets, 180 mg, single dose
  • Experimental: A
    cyclosporine 600 mg+ a single oral dose of 180 mg ticagrelor
    Interventions:
    • Drug: cyclosporine
    • Drug: ticagrelor
  • Experimental: B
    single dose cyclosporine 600 mg
    Intervention: Drug: cyclosporine
  • Experimental: C
    single dose 180 mg ticagrelor
    Intervention: Drug: ticagrelor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01504906
D5130C00074
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Chair: Miriana Kujacic, MD Molndal, Sweden AstraZeneca
Principal Investigator: Kelli Craven, MD Overland Park US, Quintiles, Inc.
AstraZeneca
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP