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Naloxegol

Phase 1

Opioid Induced Constipation | Small molecule | Gastrointestinal |AstraZeneca PLC|Last Updated: Oct 15, 2014

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
RandomizedCONTROLLED
Total Trials1
Total Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01623609Open Label, Healthy Volunteers, Bioequivalence Study With NaloxegolPHASE1 COMPLETED 42 — — Jul 1, 2012Sep 1, 2012Oct 15, 20141 United Kingdom
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Study Endpoints
Primary Endpoints
Description of the pharmacokinetic (PK) profile for naloxegol in terms of maximum observed plasma concentration (Cmax) and area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC) for each treatment period.
Predose,0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours
Secondary Endpoints
Description of the safety profile in terms of adverse events, clinical laboratory assessments , vital signs (blood pressure and pulse rate), physical examinations, electrocardiograms, and Columbia-Suicide Severity Rating scale (CSSRS)
From baseline day 1 through to Follow-up (Maximum 40 days)
Description of the pharmacokinetic(PK) profile for naloxegol in terms of time to Cmax (tmax), terminal half-life (t1/2λz), terminal rate constant (λz). For each treatment period
Predose,0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours
Description of the pharmacokinetic (PK) profile for naloxegol in terms of area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-t)].For each treatment period
Predose,0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
AEXPERIMENTALNaloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation under fasted conditions
BEXPERIMENTALNaloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation under fed conditions
CEXPERIMENTALNaloxegol film-coated IR tablet 25 mg Phase III formulation under fasted conditions
Interventions
NameTypeDescription
NaloxegolDRUGNaloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Female non-pregnant, non-lactating. * Volunteers with suitable veins for cannulation or repeated venipuncture. * Male healthy volunteers should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after dosing with the investigationa...

Countries:United Kingdom
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