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Ticagrelor whole

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01887626Study to Investigate if the Uptake of Ticagrelor Into the Body Differs Depending on Method of Administration.PHASE1 COMPLETED 36 — — Jul 1, 2013Sep 1, 2013Sep 18, 20131 United Kingdom
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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 — 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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