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NKTR118 Group1

Phase 1

Renal Impairment | Small molecule | Nephrology |AstraZeneca PLC|Last Updated: Oct 15, 2014

Success Probability

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

NKTR118 Group1 · 1 trial · 1 indication

Phase 1 1
NCT01372826Assessing the Pharmacokinetics of NKTR-118 in Subjects With Renal Impairment Compared to That in Subjects With Normal Renal FunctionRenal Impairment
COMPLETED32 Analytics
PHASE1COMPLETED
Assessing the Pharmacokinetics of NKTR-118 in Subjects With Renal Impairment Compared to That in Subjects With Normal Renal Function
Renal Impairment
NCT0137282632
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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 to 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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Frequently asked questions about NKTR118 Group1

What is NKTR118 Group1 used for?

NKTR118 Group1 is an investigational small molecule being studied for use in renal impairment. It is in Phase 1 clinical development for this condition. The drug is not yet approved and remains under investigation.

Who makes NKTR118 Group1?

NKTR118 Group1 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical research on this investigational small molecule for renal impairment.

What phase is NKTR118 Group1 in?

NKTR118 Group1 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed for this candidate.

What clinical trials is NKTR118 Group1 in?

NKTR118 Group1 has one completed clinical trial, NCT01372826, which assessed its pharmacokinetics in subjects with renal impairment compared to those with normal renal function. The trial enrolled 32 participants in the United States.

Is NKTR118 Group1 the same as NKTR-118?

NKTR118 Group1 is the same drug as NKTR-118. The clinical trial NCT01372826 uses the name NKTR-118 in its title, while the drug is also referred to as NKTR118 Group1 in development records.