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NKTR118 Group1

Phase 1

Renal Impairment | Small molecule | Nephrology |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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01372826Assessing the Pharmacokinetics of NKTR-118 in Subjects With Renal Impairment Compared to That in Subjects With Normal Renal FunctionPHASE1 COMPLETED 32 — — Jun 1, 2011Nov 1, 2011Oct 15, 20143 United States
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Study Endpoints
Primary Endpoints
To assess the pharmacokinetics of a single dose of NKTR-118 25 mg by assessment of area under the curve over the time (AUC)
PK blood samples will be collected in treatment periods 1 and 2 at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 h post-dose.

Groups 1 (normal), 2 (moderate), 3 (severe), and for Group 4 (End-stage renal disease requiring hemodialysis)

To assess the pharmacokinetics of a single dose of NKTR-118 25 mg by assessment of maximum concentration (Cmax)
PK blood samples will be collected in treatment periods 1 and 2 at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 h post-dose.

Groups 1 (normal), 2 (moderate), 3 (severe), and for Group 4 (End-stage renal disease requiring hemodialysis)

Secondary Endpoints
To assess the safety and tolerability of NKTR-118 in subjects with renal impairment and normal renal function by assessing Adverse events.
Duration Day -1 to follow-up at either visit 3 or 6 dependant on treatment
To assess the safety and tolerability of NKTR-118 in subjects with renal impairment and normal renal function by assessing vital signs
Duration Day -1 to follow-up at either visit 3 or 6 dependant on treatment
To assess the safety and tolerability of NKTR-118 in subjects with renal impairment and normal renal function by assessing safety blood samples
Duration Day -1 to follow-up at either visit 3 or 6 dependant on treatment
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
NKTR118 Group1EXPERIMENTALNormal Renal Function
NKTR118 Group 2EXPERIMENTALModerate Renal Function
NKTR118 Group 3EXPERIMENTALSevere Renal Impairment
NKTR118 Group 4EXPERIMENTALEnd-Stage Renal Disease
Interventions
NameTypeDescription
NKTR118 Group1DRUGOral dose, 25 mg
NKTR118 Group 2DRUGOral dose, 25 mg
NKTR118 Group3DRUGOral dose, 25 mg
NKTR118DRUGOral dose, 25 mg
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Provision of signed written and dated informed consent prior to any study specific procedures. * Male or female volunteers aged 18 to 80 years (inclusive) having normal renal function, or suffering from moderate or severe renal impairment or ESRD. Male subjects who are sexual...

Countries:United States
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