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Ticagrelor whole

Phase 1

Bioavailability Heathy Volunteers | Small molecule | Other |AstraZeneca PLC|Last Updated: Sep 18, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

Ticagrelor whole is a small molecule being investigated for use in healthy volunteers to study bioavailability. It is currently in Phase 1 clinical development, with a completed trial that examined how the uptake of ticagrelor into the body differs depending on the method of administration.

Who makes Ticagrelor whole?

Ticagrelor whole is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical research on this small molecule, with a Phase 1 trial focused on bioavailability in healthy volunteers.

What phase is Ticagrelor whole in?

Ticagrelor whole is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied for its bioavailability in healthy volunteers. One Phase 1 trial has been completed, and the drug remains in early-stage clinical research.

What clinical trials is Ticagrelor whole in?

Ticagrelor whole has one completed clinical trial, NCT01887626, titled "Study to Investigate if the Uptake of Ticagrelor Into the Body Differs Depending on Method of Administration." This Phase 1 trial enrolled 36 healthy volunteers in the United Kingdom and was controlled but not double-blinded.

Is Ticagrelor whole the same as ticagrelor?

Ticagrelor whole is a formulation of ticagrelor, a small molecule. The trial NCT01887626 investigates how the uptake of ticagrelor into the body differs depending on the method of administration, indicating that Ticagrelor whole refers to a specific formulation or administration method being studied.