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AZD8329

Phase 1

Overweight | Small molecule | Metabolic |AstraZeneca PLC|Trials Updated: May 10, 2011

AZD8329 development status

Highest phase Phase 1
Registered trials 3 across 1 sponsor since Jul 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials2
Total Enrollment63

FDA Designations

No designations recorded

AZD8329 clinical trials

AZD8329 · 2 trials · 4 indications

Phase 1 2
NCT01225939A Study Conducted Over 3 Periods to Look at the Drug in the BodyType 2 Diabetes Mellitus
COMPLETED18 Analytics
NCT01207089To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Administration of AZD8329Overweight
COMPLETED45 Analytics
PHASE1COMPLETED
A Study Conducted Over 3 Periods to Look at the Drug in the Body
Type 2 Diabetes Mellitus
NCT0122593918
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PHASE1COMPLETED
To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Administration of AZD8329
Overweight
NCT0120708945
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Study Endpoints

Primary Endpoints

Compare the pharmacokinetics (Cmax and AUC) of the oral solution and the oral solid formulation of AZD8329.
Information will be collected during 48h after each dose.
Safety variables (adverse events).
Adverse events day -1
Safety variables (clinical laboratory assessments).
Clinical labs day 1
Safety variables (adverse events)
Adverse events will colletected entire study
Safety variables (vital signs)
vital signs every hour during day 1
Safety variables (physical examination)
performed at screening
Safety variables (telemetry)
telemetry for 24hr. post dose day 1
Safety variables (digital electrocardiograms (dECGs))
dECG during 5min, 13 times 24 hr after dose day 1
Safety variables (safety 12-lead paper electrocardiograms (pECG))
pECG at screening

Secondary Endpoints

Explore the effect of food on the pharmacokinetics (Tmax, T1/2 and CL/F) of AZD8329 oral solid formulation.
Information will be collected during 48h after dose.
Investigate the safety and tolerability of AZD8329 administered as two different oral formulations.(Safety variables: Adverse events, Vital Signs, Clinical chemistry, Electrocardiogram (p ECG))
Adverse event will be collected from first dose to last visit . Clinical chemistry, Vital Signs and pECG's will be collected at all 5 visits
Pharmacokinetics Plasma and urine concentrations of AZD8329 and plasma and urine pharmacokinetics parameters
Information will be collected during day -1, day 1, 2, 3 and 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALSingle Oral dose AZD8329 tablet (fasting)
2EXPERIMENTALSingle Oral dose AZD8329 solution (fasting)
3EXPERIMENTALSingle Oral dose AZD8329 tablet (Fed)

Interventions

NameTypeDescription
AZD8329DRUGtablet
PlaceboDRUGPlacebo AZD8329 Oral Solution
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of signed and dated written informed consent before any study specific procedures including consent for genetic research exploring genetic variations in CYP3A5 * suitable veins for cannulation or repeated venepuncture * Subjects should have a body mass index (BMI) be...

Countries:United Kingdom
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Frequently asked questions about AZD8329

What is AZD8329?

AZD8329 is an investigational small molecule developed by AstraZeneca PLC for metabolic conditions, specifically overweight and Type 2 Diabetes Mellitus. It has been studied in Phase 1 clinical trials and is not approved for any indication.

What is AZD8329 used for?

AZD8329 is being developed for the treatment of overweight and Type 2 Diabetes Mellitus. It is an investigational drug and has not been approved for any use.

Who makes AZD8329?

AZD8329 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical trials evaluating this drug.

What phase is AZD8329 in?

AZD8329 is in Phase 1 clinical development. It has completed Phase 1 trials and is not yet approved for marketing. The trials were conducted in the United Kingdom.

What clinical trials is AZD8329 in?

AZD8329 has been evaluated in two completed Phase 1 trials: NCT01225939, which studied the drug in the body in Type 2 Diabetes Mellitus patients, and NCT01207089, which assessed safety, tolerability, pharmacokinetics, and pharmacodynamics in overweight healthy male volunteers.

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