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Nektar 118

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment214

FDA Designations

No designations recorded

Clinical trial landscape

Nektar 118 · 1 trial · 1 indication

Phase 1 1
NCT01533155Study in Healthy Volunteers to Investigate the Effects of Quinidine on the Pharmacokinetics of NKTR-118Drug Induced Constipation
COMPLETED214 Analytics
PHASE1COMPLETED
Study in Healthy Volunteers to Investigate the Effects of Quinidine on the Pharmacokinetics of NKTR-118
Drug Induced Constipation
NCT01533155214
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Study Endpoints

Primary Endpoints

Description of the pharmacokinetic (PK) profile for NKTR- 118 in terms of maximum observed plasma concentration (Cmax), time to Cmax (tmax), apparent terminal half-life (t1/2λz).
At predose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose.
Description of the PK profile for NKTR- 118 in terms of apparent terminal rate constant (λz), area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC).
At predose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose.
Description of the PK profile for NKTR 118 in terms of area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-t)].
At predose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose.
Description of the PK profile for NKTR 118 in terms of area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)].
At predose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose.
Description of the PK profile for NKTR 118 in terms of apparent oral clearance from plasma (CL/F), and apparent volume of distribution during the terminal phase (Vz/F).
At predose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose.

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.
From baseline up to 21 days.
Description of results from pupillary measurements in terms of size change from baseline on both eyes in mm. (Measurements in 4 different conditions: dark, 0.04 lux, 0.4 lux and 4 lux)
Measurments from baseline day -1, and at 0.5, 1, 2, 3, 4, 6, and 24 hours post dose.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
NKTR-118/ QuinidineACTIVE_COMPARATOROne 25-mg NKTR-118 tablet will be administered once with 3 Quinidine 200mg tablets in the morning of period 1 or period 2 (part 1)
NKTR-118/ PlaceboPLACEBO_COMPARATOROne 25-mg NKTR-118 tablet will be administered once with 3 Placebo tablets in the morning of period 1 or period 2 (part 1)
NKTR-118/ Quinidine/ MorphineACTIVE_COMPARATOROne 25-mg NKTR-118 tablet will be administered with 3 Quinidine 200mg tablets with Morphine inj 5mg/70kg once in the morning on period 3 or period 4 (Part 2)
NKTR-118/ Placebo/ MorphinePLACEBO_COMPARATOROne 25-mg NKTR-118 tablet will be administered with 3 placebo tables with Morphine inj 5mg/70kg once in the morning of period 3 or period 4 (part 2)

Interventions

NameTypeDescription
Nektar 118DRUGOral 25 mg tablet
QuinidineDRUGOral 200 mg tablet
Quinidine placeboDRUGOral Tablet
MorphineDRUG10 mg/ml, intravenously
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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. * Male and female (nonchildbearing potential, nonlactating) healthy volunteers aged 18 to 55 years inclusive, with suitable veins for cannulation or repeated venipuncture. * Female ...

Countries:United States
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Frequently asked questions about Nektar 118

What is Nektar 118 used for?

Nektar 118 is an investigational small molecule being developed for the treatment of drug induced constipation. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in clinical trials.

What does Nektar 118 target?

The specific molecular target of Nektar 118 has not been disclosed in available information. The drug is being studied for its effects on drug induced constipation, but its mechanism of action has not been publicly detailed.

Who makes Nektar 118?

Nektar 118 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical research on this investigational drug for the treatment of drug induced constipation.

What phase is Nektar 118 in?

Nektar 118 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied in early-stage clinical trials to evaluate its safety, tolerability, and pharmacokinetics in healthy volunteers.

What clinical trials is Nektar 118 in?

Nektar 118 has been studied in one completed Phase 1 clinical trial with the identifier NCT01533155. This trial, titled 'Study in Healthy Volunteers to Investigate the Effects of Quinidine on the Pharmacokinetics of NKTR-118,' enrolled 214 participants in the United States and evaluated the drug's interaction with quinidine in healthy volunteers.

Is Nektar 118 the same as NKTR-118?

Yes, Nektar 118 is also known as NKTR-118. The clinical trial NCT01533155 refers to the drug as NKTR-118, and this is the same investigational drug being developed by AstraZeneca for the treatment of drug induced constipation.