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Ticagrelor whole

Phase 1

Undisclosed | Small molecule | Other |AstraZeneca PLC|Trials Updated: Sep 18, 2013

Ticagrelor whole target and mechanism

Molecular targetP2RY12
Target classNegative Allosteric Modulator
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Ticagrelor whole clinical trials

Ticagrelor whole · 1 trial · 1 indication

Phase 1 1
NCT01887626Study to Investigate if the Uptake of Ticagrelor Into the Body Differs Depending on Method of Administration.Bioavailability Heathy Volunteers
COMPLETED36 Analytics
PHASE1COMPLETED
Study to Investigate if the Uptake of Ticagrelor Into the Body Differs Depending on Method of Administration.
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Study Endpoints

Primary Endpoints

Description of the pharmacokinetic(PK) profile in terms of plasma concentration-time curve (AUC) of ticagrelor
PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
Description of the pharmacokinetic(PK) profile in terms of AUC of the active metabolite of ticagrelor
PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
Description of the pharmacokinetic(PK) profile in terms of maximum plasma concentration (Cmax) of ticagrelor
PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
Description of the pharmacokinetic(PK) profile in terms of Cmax of the active metabolite of ticagrelor
PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose

Secondary Endpoints

Description of the safety profile in terms of adverse events (AE)
From first dose through to the follow-up visit.
Description of the safety profile in terms of laboratory variables
Safety labs at screening, Day -1, Day 3 (48 hours after treatment) and follow-up
Description of the safety profile in terms of vital signs
Vital signs at screening, pre-dose, 1 h, 3, 6, 12 and 24 hours post-dose, Day 3 for all treatment periods and follow-up
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
AEXPERIMENTALTicagrelor 90 mg as a whole tablet
BEXPERIMENTALTicagrelor 90 mg tablet crushed and suspended in water
CEXPERIMENTALDispersed ticagrelor 90 mg tablet suspended in water and administered through a nasogastric tube into the the stomach

Interventions

NameTypeDescription
Ticagrelor 90 mg whole tabletDRUGTicagrelor 90 mg whole tablet administered as a single oral dose
Ticagrelor 90 mg tablet crushedDRUGTicagrelor 90 mg crushed and suspended in water
Dispersed ticagrelor 90 mg tablet suspended in water - nasogastric tubeDRUGDispersed 90 mg ticagrelor 90 mg tablet suspended in water and administered through a nasogastric tube into the stomach
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female volunteers aged 18 to 50 years (inclusive) with suitable veins for cannulation or repeated venepuncture * Have a body mass index between 18 and 30 kg/m2 (inclusive) and weigh at least 50 kg (110 pounds \[lbs\]) and no more than 100 kg (220 lbs). * Provi...

Countries:United Kingdom
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Frequently asked questions about Ticagrelor whole

What is Ticagrelor whole?

Ticagrelor whole refers to the intact 90 mg tablet form of ticagrelor, a small molecule drug developed by AstraZeneca PLC. It is also known as Ticagrelor 90 mg whole tablet. The whole tablet is studied to understand how the body absorbs the drug when the tablet is swallowed intact rather than crushed or chewed.

What does Ticagrelor whole target?

Ticagrelor whole targets P2RY12, the platelet P2Y12 receptor. It acts as a negative allosteric modulator at this receptor. By binding to P2RY12, ticagrelor inhibits platelet activation and aggregation, which is the basis for its antiplatelet activity.

Who makes Ticagrelor whole?

Ticagrelor whole is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the company responsible for the development and clinical study of this tablet formulation.

What phase is Ticagrelor whole in?

Ticagrelor whole is in Phase 1 clinical development. It is an investigational formulation, and the Phase 1 program has been completed. The drug has not been approved for any indication based on the available development data.

What clinical trials is Ticagrelor whole in?

Ticagrelor whole has been studied in one completed Phase 1 trial, NCT01887626, titled "Study to Investigate if the Uptake of Ticagrelor Into the Body Differs Depending on Method of Administration." The trial enrolled 36 healthy volunteers in the United Kingdom and was a randomized, controlled bioavailability study.