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NKTR118 Formulation 1

Phase 1

Healthy | Small molecule | Other |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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment21
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01365000Assessment of Relative Bioavailability of NKTR-118 in Three Formulations in Healthy SubjectsPHASE1 COMPLETED 21 — — Jun 1, 2011Aug 1, 2011Oct 15, 20141 United States
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Study Endpoints
Primary Endpoints
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of (Cmax)
day-1 to day 3
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of time to Cmax (tmax)
day-1 to day 3
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of half-life (t1/2λz)
day-1 to day 3
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of area under concentration-time curve (AUC(0-t))
day-1 to day 3
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of area from time zero (pre-dose) extrapolated to infinity (AUC).
day-1 to day 3
Secondary Endpoints
Safety and tolerability of NKTR-118 following administration of a single oral doses of NKTR-118 of 3 different formulations during fed and fasted conditions by assessing adverse events
Duration day -1 (Visit 2) to follow up (Visit 12)
Safety and tolerability of NKTR-118 following administration of a single oral doses of NKTR-118 of 3 different formulations during fed and fasted conditions by assessing Safety Laboratory values
Duration day -1 (Visit 2) to follow up (Visit 12)
Safety and tolerability of NKTR-118 following administration of a single oral doses of NKTR-118 of 3 different formulations during fed and fasted conditions by assessing 12-Lead Electrocardiograms
Duration day -1 (Visit 2) to follow up (Visit 12)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
NKTR118 Formulation 1EXPERIMENTALFasted
NKTR118 Formulation 2EXPERIMENTALFasted
NKTR118 Formulation 3EXPERIMENTALFasted
NKTR118 Formulation 1aEXPERIMENTALFed
NKTR118 Formulation 3aEXPERIMENTALFED
Interventions
NameTypeDescription
NKTR118 Formulation 1DRUGOral dose, 25 mg
NKTR118 Formulation 2DRUGOral dose, 25 mg
NKTR118 Formulation 3DRUGOral dose, 25 mg
NKTR118 Formulation 1aDRUGOral dose, 25 mg
NKTR118 Formulation 3aDRUGOral dose, 25 mg
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study-specific procedures * Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating, and must be of non-childbearing potential, confirmed at screening by f...

Countries:United States
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