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AZD5847

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Oct 11, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment124

FDA Designations

No designations recorded

Clinical trial landscape

AZD5847 · 2 trials · 1 indication

Phase 1 2
NCT01116258A Study in Healthy Volunteers to Assess Safety and Blood Levels of AZD5847 After Multiple Doses Over 14 DaysHealthy
COMPLETED60 Analytics
NCT01037725Study to Evaluate Safety, Tolerability and Pharmacokinetics (PK) (Including Food Effect) of Oral Doses of AZD5847 in Healthy VolunteersHealthy
COMPLETED64 Analytics
PHASE1COMPLETED
A Study in Healthy Volunteers to Assess Safety and Blood Levels of AZD5847 After Multiple Doses Over 14 Days
Healthy
NCT0111625860
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PHASE1COMPLETED
Study to Evaluate Safety, Tolerability and Pharmacokinetics (PK) (Including Food Effect) of Oral Doses of AZD5847 in Healthy Volunteers
Healthy
NCT0103772564
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Study Endpoints

Primary Endpoints

Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, digital ECG, telemetry)
collected prior to treatment, during treatment, and follow-up for a total of 25 to 52 days(includes upto 28 days for screening)
Safety and tolerability of AZD5847 administered orally will be assessed by incidence and severity of AE's, abnormalities in vital sign assessments, ECG's, telemetry, clinical laboratory assessments, physical exams and withdrawals
Safety assessments are taken prior to and after drug administration. Volunteers will be monitored througout the study for adverse events.

Secondary Endpoints

characterize the Pharmacokinetics of AZD9742 in blood and urine
PK-sampling during 14 pre-defined study days for PK profiling
To characterize the pharmacokinetics of AZD5847 in blood and urine following oral doses.
Samples taken during the residential period at defined timepoints pre-dose and post-dose.
To assess the effect of food on the pharmacokinetics of AZD5847 following oral administration of AZD5847
Samples taken during the residential period at defined timepoints pre-dose and post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
AZD5847 oral suspensionEXPERIMENTALActive
Placebo to AZD5847PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
AZD5847DRUGoral suspension, 15 days
PlaceboDRUGoral suspension, 15 days
Placebo to AZD5847DRUGIn Part A - Single oral doses of AZD5847placebo given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo) on Day 1
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * BMI between 18-30 Exclusion Criteria: * Use of drugs that inhibit or induce cytochrome P450 3A4 enzymes * History of presence of gastrointestinal, hepatic or renal disease

Countries:United States
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Frequently asked questions about AZD5847

What is AZD5847 used for?

AZD5847 is an investigational small molecule being studied in healthy volunteers. It is being evaluated in Phase 1 clinical trials to assess its safety, tolerability, and pharmacokinetics, including the effect of food on oral dosing. The drug is not approved for any condition and remains in clinical development.

Who makes AZD5847?

AZD5847 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting Phase 1 clinical trials of this investigational small molecule in healthy volunteers.

What phase is AZD5847 in?

AZD5847 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers. The drug is investigational and has not been approved by regulatory authorities. Its safety and pharmacokinetics are being evaluated in these early-stage studies.

What clinical trials is AZD5847 in?

AZD5847 has been studied in two completed Phase 1 clinical trials. NCT01037725 evaluated safety, tolerability, and pharmacokinetics, including food effect, of oral doses in 64 healthy volunteers. NCT01116258 assessed safety and blood levels after multiple doses over 14 days in 60 healthy volunteers. Both trials were conducted in the United States.

Is AZD5847 FDA approved?

AZD5847 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trials have focused on healthy volunteers to evaluate safety, tolerability, and pharmacokinetics. The drug has not progressed to later-stage trials or received regulatory approval.