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AZD4017

Phase 2

Raised Intraocular Pressure | Small molecule | Ophthalmology |AstraZeneca PLC|Last Updated: Feb 14, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

AZD4017 · 5 trials · 4 indications

Phase 2 1Phase 1 4
NCT01173471A Phase IIa Study to Assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-ocular PressureRaised Intraocular Pressure
COMPLETED50 Analytics
PHASE2COMPLETED
A Phase IIa Study to Assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-ocular Pressure
Raised Intraocular Pressure
NCT0117347150
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Study Endpoints

Primary Endpoints

Percentage Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment
Baseline to 4 weeks
To investigate the effect of single and repeated doses of AZD4017 and placebo on mechanisms in adipose tissue involved in metabolic regulation
A adipose tissue biospy is taken at baseline, on first day of dosing day, on 4th dosing day and on 9th dosing day.
Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables
The variables will be measured predose and then repeatedly during the study
Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratoryvariables
The variables will be measure predose and the repeatedly during the following 47 hours after dosing

Secondary Endpoints

Clinically Relevant Change in Intra-ocular Pressure After 4 Weeks of Treatment
Baseline to 4 weeks
Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment
Baseline to 4 weeks
Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables
The variables will be measure predose and the repeatedly during the following 10 days after dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1) AZD4017EXPERIMENTALEurope: 200 mg AZD4017
2) PlaceboPLACEBO_COMPARATOREurope: placebo
3) AZD4017EXPERIMENTALUSA: 800 mg AZD4017
4) PlaceboPLACEBO_COMPARATORUSA: placebo
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
AZD4017DRUGtablet, oral, one tablet once daily, 28 days
PlaceboDRUGmatching placebo tablet, oral, one tablet once daily, 28 days
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Must have a diagnosis of intra-ocular hypertension (raised IOP), or primary open-angle glaucoma (POAG), with IOP \>20 mmHg and ≤36 mmHg in the study eye, and is currently prescribed a stable dose of a single anti-glaucoma medication that began at least 30 days prior to the scr...

Countries:United StatesSwedenUnited KingdomJapan
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Frequently asked questions about AZD4017

What is AZD4017 used for?

AZD4017 is an investigational small molecule being studied for raised intraocular pressure, obesity, and type 2 diabetes mellitus. It has been evaluated in healthy volunteers and in patients with raised intraocular pressure. The drug is in clinical development and is not approved for any indication.

What does AZD4017 target?

AZD4017 is a small molecule being developed by AstraZeneca for metabolic conditions. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being studied for its effects on glucose metabolism and intraocular pressure.

Who makes AZD4017?

AZD4017 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company has sponsored clinical trials of AZD4017 in healthy volunteers and in patients with raised intraocular pressure.

What phase is AZD4017 in?

AZD4017 has completed Phase 1 and Phase 2 clinical trials. The Phase 1 trials assessed safety and tolerability in healthy volunteers, while a Phase 2a study evaluated the drug for raised intraocular pressure. All trials listed are completed, and the drug remains investigational.

What clinical trials is AZD4017 in?

AZD4017 has been studied in several completed trials. NCT00791752 and NCT00799747 were Phase 1 single ascending dose studies in healthy male volunteers in Sweden and Japan. NCT00841048 was a Phase 1 multiple ascending dose study in healthy volunteers with type 2 diabetes. NCT01173471 was a Phase 2a study for raised intraocular pressure.

Is AZD4017 the same as any other drug?

AZD4017 is the code name used by AstraZeneca for this investigational compound. No alternative brand names or other designations have been disclosed in the clinical trial records. The drug is identified solely by its development code AZD4017.