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AZD5847

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment124
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01116258A Study in Healthy Volunteers to Assess Safety and Blood Levels of AZD5847 After Multiple Doses Over 14 DaysPHASE1 COMPLETED 60 — — Apr 1, 2010Oct 1, 2010Oct 11, 20101 United States
NCT01037725Study to Evaluate Safety, Tolerability and Pharmacokinetics (PK) (Including Food Effect) of Oral Doses of AZD5847 in Healthy VolunteersPHASE1 COMPLETED 64 — — Dec 1, 2009Apr 1, 2010Jul 14, 20101 United States
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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 — 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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