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AZD5985

Phase 1

Undisclosed | Small molecule | Other |AstraZeneca PLC|Trials Updated: Jun 9, 2009

AZD5985 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Nov 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

AZD5985 clinical trials

AZD5985 · 1 trial · 1 indication

Phase 1 1
NCT00799331Exploratory Study to Assess the Pharmacokinetics of AZD5985Healthy
COMPLETED32 Analytics
PHASE1COMPLETED
Exploratory Study to Assess the Pharmacokinetics of AZD5985
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Study Endpoints

Primary Endpoints

It is the objective of this exploratory study to assess pharmacokinetics of AZD5985 following administration of single increasing doses. The primary variable is plasma concentration of AZD5985.
Frequent sampling occasions during study days
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
AEXPERIMENTALAZD5985
BEXPERIMENTALplacebo

Interventions

NameTypeDescription
AZD5985DRUGOral suspension. Single oral doses of AZD5985 starting with 4 mg and subsequently with up to 3 dose escalations will be administered not exceeding AstraZeneca pre-defined upper exposure limits.
placeboDRUGOral suspension.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of signed, written and dated informed consent prior to any study specific procedures. * Healthy male subjects aged 18 to 45 years (inclusive). * Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg. * Be non-smoker or ...

Countries:Germany
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Frequently asked questions about AZD5985

What is AZD5985?

AZD5985 is an investigational small molecule drug developed by AstraZeneca PLC. It has been studied in a Phase 1 clinical trial in healthy adult male volunteers in Germany. The specific disease or condition it is intended to treat has not been publicly disclosed.

Who makes AZD5985?

AZD5985 is made by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the developer responsible for the clinical program for this investigational small molecule.

What phase is AZD5985 in?

AZD5985 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed for this asset.

What clinical trials is AZD5985 in?

AZD5985 has been evaluated in one completed Phase 1 trial, NCT00799331, titled an Exploratory Study to Assess the Pharmacokinetics of AZD5985. The trial enrolled 32 healthy male volunteers aged 18 years and older in Germany and used a randomized, double-blind, controlled design.

What is AZD5985 used for?

AZD5985 is an investigational drug whose intended therapeutic use has not been publicly disclosed. Its only reported clinical study was conducted in healthy volunteers rather than in patients with a specific disease, which is typical of early Phase 1 pharmacokinetic research.