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

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ClinicalTrials.gov Identifier: NCT01504906
Recruitment Status : Completed
First Posted : January 6, 2012
Last Update Posted : December 12, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE January 2, 2012
First Posted Date  ICMJE January 6, 2012
Last Update Posted Date December 12, 2012
Study Start Date  ICMJE January 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2012)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2012)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess Effect of Cyclosporine on the Blood Levels of Ticagrelor
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: cyclosporine
    Oral tablets, 600 mg , single dose
  • Drug: ticagrelor
    Oral tablets, 180 mg, single dose
Study Arms  ICMJE
  • 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
Publications * Teng R, Kujacic M, Hsia J. Pharmacokinetic interaction study of ticagrelor and cyclosporine in healthy volunteers. Clin Drug Investig. 2014 Aug;34(8):529-36. doi: 10.1007/s40261-014-0205-2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 5, 2012)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01504906
Other Study ID Numbers  ICMJE D5130C00074
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Miriana Kujacic, MD Molndal, Sweden AstraZeneca
Principal Investigator: Kelli Craven, MD Overland Park US, Quintiles, Inc.
PRS Account AstraZeneca
Verification Date December 2012

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