Study to Assess Effect of Cyclosporine on the Blood Levels of Ticagrelor - Full Text View

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: cyclosporine Drug: ticagrelor	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Cyclosporine Ticagrelor

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	20
Study Start Date:	January 2012
Study Completion Date:	June 2012
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A cyclosporine 600 mg+ a single oral dose of 180 mg ticagrelor	Drug: cyclosporine Oral tablets, 600 mg , single dose Drug: ticagrelor Oral tablets, 180 mg, single dose
Experimental: B single dose cyclosporine 600 mg	Drug: cyclosporine Oral tablets, 600 mg , single dose
Experimental: C single dose 180 mg ticagrelor	Drug: ticagrelor Oral tablets, 180 mg, single dose

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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01504906

Locations

United States, Kansas
Research site
Overland Park, Kansas, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Study Chair:	Miriana Kujacic, MD	Molndal, Sweden AstraZeneca
Principal Investigator:	Kelli Craven, MD	Overland Park US, Quintiles, Inc.

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01504906 History of Changes
Other Study ID Numbers:	D5130C00074
Study First Received:	January 2, 2012
Last Updated:	December 11, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Phase 1
Healthy male volunteers
pharmacokinetics

cyclosporine
ticagrelor
Bioavailability (plasma AUC, Cmax, plasma AUC0-t, t1/2λz, tmax)

Additional relevant MeSH terms:

Cyclosporins
Cyclosporine
Ticagrelor
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents

Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 16, 2013