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AZD8329

Phase 1

Healthy Men | Small molecule | Other |AstraZeneca PLC|Last Updated: May 10, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment119

FDA Designations

No designations recorded

Clinical trial landscape

AZD8329 · 3 trials · 5 indications

Phase 1 3
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
NCT00935662A First Time in Man, Study to Assess the Safety of AZD8329 After Single Ascending Oral DosesHealthy Men
COMPLETED119 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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PHASE1COMPLETED
A First Time in Man, Study to Assess the Safety of AZD8329 After Single Ascending Oral Doses
Healthy Men
NCT00935662119
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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
Safety measurements (ECG's, Pulse, Blood Pressure, Safety Laboratory and Adverse Events)
Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study.

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)
AZD8329EXPERIMENTALAZD8329 oral solution
PlaceboPLACEBO_COMPARATORPlacebo for AZD8329 oral solution

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 KingdomSweden
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Frequently asked questions about AZD8329

What is AZD8329 used for?

AZD8329 is an investigational small molecule being studied for use in healthy men, overweight men, and men with Type 2 Diabetes Mellitus. It has been evaluated in early-stage clinical trials to assess its safety, tolerability, and how the body processes the drug.

Who makes AZD8329?

AZD8329 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the NASDAQ under the ticker symbol AZN. The company has sponsored Phase 1 clinical trials of this investigational drug.

What phase is AZD8329 in?

AZD8329 is in Phase 1 clinical development. All three completed trials for this drug were Phase 1 studies. It is an investigational drug and has not been approved by regulatory authorities.

What clinical trials is AZD8329 in?

AZD8329 has been studied in three completed Phase 1 trials: NCT00935662, a single ascending dose study in healthy men in Sweden; NCT01207089, a study in overweight healthy men in the United Kingdom; and NCT01225939, a study in men with Type 2 Diabetes Mellitus in the United Kingdom.

Is AZD8329 the same as other drugs?

AZD8329 is the only name provided for this investigational drug. No alternative names have been reported in the clinical trial records. It is a distinct small molecule being developed by AstraZeneca.