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AZD5847

Phase 2

Undisclosed | Small molecule | Other |AstraZeneca PLC|Trials Updated: Oct 11, 2010

AZD5847 development status

Highest phase Phase 2 run by National Institute of Allergy and Infectious Diseases (NIAID) (NCT01516203)
Phase scored for AZNPhase 1
Registered trials 3 across 2 sponsors since Dec 2009

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

AZD5847 clinical trials

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
HealthyUnlock trial analytics
PHASE1COMPLETED
Study to Evaluate Safety, Tolerability and Pharmacokinetics (PK) (Including Food Effect) of Oral Doses of AZD5847 in Healthy Volunteers
HealthyUnlock trial analytics

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?

AZD5847 is an investigational small molecule developed by AstraZeneca PLC. It has been studied in Phase 1 clinical trials in healthy adult volunteers, and its intended therapeutic indication has not been publicly disclosed. Two Phase 1 trials of AZD5847 have been completed, both conducted in the United States.

Who makes AZD5847?

AZD5847 is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca sponsored both completed Phase 1 studies of the compound, which were run in the United States in healthy adult volunteers.

What phase is AZD5847 in?

AZD5847 is in Phase 1 development. Two Phase 1 trials have been completed, and no active trials are currently listed. The studies enrolled a combined total of 124 healthy volunteers, so the program remains at the earliest stage of clinical testing.

What clinical trials is AZD5847 in?

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

How was AZD5847 studied in its clinical trials?

Both AZD5847 trials were Phase 1 studies in healthy volunteers aged 18 and older, and both were randomized, double-blind and placebo-controlled. NCT01116258 enrolled 60 participants to assess safety and blood levels over 14 days of multiple dosing, while NCT01037725 enrolled 64 participants to evaluate safety, tolerability and pharmacokinetics, including food effect.

Is AZD5847 approved by the FDA?

AZD5847 is not approved. It is an investigational small molecule that has completed only Phase 1 clinical testing, with two completed trials in healthy volunteers. No Phase 2 or later development has been reported for AZD5847.