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NKTR118 Formulation 1

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Oct 15, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

NKTR118 Formulation 1 · 1 trial · 1 indication

Phase 1 1
NCT01365000Assessment of Relative Bioavailability of NKTR-118 in Three Formulations in Healthy SubjectsHealthy
COMPLETED21 Analytics
PHASE1COMPLETED
Assessment of Relative Bioavailability of NKTR-118 in Three Formulations in Healthy Subjects
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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 to 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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Frequently asked questions about NKTR118 Formulation 1

What is NKTR118 Formulation 1 used for?

NKTR118 Formulation 1 is an investigational small molecule being studied in healthy volunteers. It is being evaluated in a Phase 1 clinical trial to assess the relative bioavailability of NKTR-118 in three formulations. The drug is not approved and is still in clinical development.

Who makes NKTR118 Formulation 1?

NKTR118 Formulation 1 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical trials to evaluate this investigational small molecule drug.

What phase is NKTR118 Formulation 1 in?

NKTR118 Formulation 1 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed.

What clinical trials is NKTR118 Formulation 1 in?

NKTR118 Formulation 1 has one completed clinical trial, NCT01365000, titled 'Assessment of Relative Bioavailability of NKTR-118 in Three Formulations in Healthy Subjects.' This Phase 1 study enrolled 21 participants in the United States and was a controlled, randomized trial.

Is NKTR118 Formulation 1 FDA approved?

NKTR118 Formulation 1 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial, NCT01365000, was a bioavailability study in healthy volunteers, and the drug has not yet progressed to later-stage trials or approval.