NCT01504906

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jan 2012

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 6, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

December 12, 2012

Status Verified

December 1, 2012

Enrollment Period

5 months

First QC Date

January 2, 2012

Last Update Submit

December 11, 2012

Conditions

Healthy

Keywords

Phase 1Healthy male volunteerspharmacokineticscyclosporineticagrelorBioavailability (plasma AUC, Cmax, plasma AUC0-t, t1/2λz, tmax)

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • 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

Study Arms (3)

A

EXPERIMENTAL

cyclosporine 600 mg+ a single oral dose of 180 mg ticagrelor

Drug: cyclosporineDrug: ticagrelor

B

EXPERIMENTAL

single dose cyclosporine 600 mg

Drug: cyclosporine

C

EXPERIMENTAL

single dose 180 mg ticagrelor

Drug: ticagrelor

Interventions

cyclosporineDRUG

Oral tablets, 600 mg , single dose

AB
ticagrelorDRUG

Oral tablets, 180 mg, single dose

AC

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research site

Overland Park, Kansas, United States

Location

Related Publications (1)

  • 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.

    PMID: 24861133DERIVED

MeSH Terms

Interventions

CyclosporineTicagrelor

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsAdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Miriana Kujacic, MD

    Molndal, Sweden AstraZeneca

    STUDY CHAIR

  • Kelli Craven, MD

    Overland Park US, Quintiles, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2012

First Posted

January 6, 2012

Study Start

January 1, 2012

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

December 12, 2012

Record last verified: 2012-12

Locations

US(1)