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Naloxegol

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

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment44

FDA Designations

No designations recorded

Clinical trial landscape

Naloxegol · 2 trials · 2 indications

Phase 1 2
NCT01623609Open Label, Healthy Volunteers, Bioequivalence Study With NaloxegolOpioid Induced Constipation
COMPLETED42 Analytics
NCT01594619Study in Healthy Volunteers to Investigate the Effects of Diltiazem on the Pharmacokinetics of NaloxegolDrug Induced Constipation
COMPLETED44 Analytics
PHASE1COMPLETED
Open Label, Healthy Volunteers, Bioequivalence Study With Naloxegol
Opioid Induced Constipation
NCT0162360942
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PHASE1COMPLETED
Study in Healthy Volunteers to Investigate the Effects of Diltiazem on the Pharmacokinetics of Naloxegol
Drug Induced Constipation
NCT0159461944
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Study Endpoints

Primary Endpoints

Description of the pharmacokinetic (PK) profile for naloxegol in terms of maximum observed plasma concentration (Cmax) and area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC) for each treatment period.
Predose,0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours
Description of the pharmacokinetic (PK) profile for naloxegol in terms of maximum observed plasma concentration (Cmax) and area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC).
At predose on Days 1 and 7 and then at 0.25, 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 (CSSRS)
From baseline day 1 through to Follow-up (Maximum 40 days)
Description of the pharmacokinetic(PK) profile for naloxegol in terms of time to Cmax (tmax), terminal half-life (t1/2λz), terminal rate constant (λz). For each treatment period
Predose,0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours
Description of the pharmacokinetic (PK) profile for naloxegol in terms of area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-t)].For each treatment period
Predose,0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
AEXPERIMENTALNaloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation under fasted conditions
BEXPERIMENTALNaloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation under fed conditions
CEXPERIMENTALNaloxegol film-coated IR tablet 25 mg Phase III formulation under fasted conditions

Interventions

NameTypeDescription
NaloxegolDRUGNaloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation
Diltiazem XRDRUGOral 240mg tablet
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Female non-pregnant, non-lactating. * Volunteers with suitable veins for cannulation or repeated venipuncture. * Male healthy volunteers should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after dosing with the investigationa...

Countries:United KingdomUnited States
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Frequently asked questions about Naloxegol

What is Naloxegol used for?

Naloxegol is a small molecule being developed for opioid induced constipation and drug induced constipation. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes Naloxegol?

Naloxegol is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN.

What phase is Naloxegol in?

Naloxegol is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. Clinical trials are ongoing to evaluate its safety and pharmacokinetics.

What clinical trials is Naloxegol in?

Naloxegol has been studied in two completed Phase 1 trials. NCT01594619 investigated the effects of diltiazem on naloxegol pharmacokinetics in healthy volunteers in the United States. NCT01623609 was a bioequivalence study in healthy volunteers in the United Kingdom.

Is Naloxegol the same as any other drug?

No alternative names for Naloxegol have been disclosed in the available information. It is referred to solely by its generic name, Naloxegol.