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AZD7325

Phase 1

Healthy Volunteer | Small molecule | Other |AstraZeneca PLC|Last Updated: Dec 10, 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_CONTROLLEDDMCBiomarker
Total Trials4
Total Enrollment136
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00769899AZD7325 Single Ascending Dose Study in Healthy Male Japanese SubjectsPHASE1 COMPLETED 48 — — Oct 1, 2008Mar 1, 2009Mar 18, 20092 United States
NCT00790114Determine the Effect of Multiple Doses of AZD7325, CYP StudyPHASE1 COMPLETED 24 — — Jul 1, 2008Sep 1, 2008Nov 13, 2008 - —
NCT00720421A Sedation/Cognition/Electroencephalogram (EEG) Study Using AZD7325 and Comparator.PHASE1 COMPLETED 16 — — Jun 1, 2008Aug 1, 2008Dec 10, 20101 Netherlands
NCT00681915AZD7325 Multiple Ascending Dose StudyPHASE1 COMPLETED 48 — — Mar 1, 2008Jul 1, 2008Dec 9, 20101 United States
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Study Endpoints
Primary Endpoints
Safety and tolerabilityThe nature and incidence of adverse events (AEs), vital signs,physical examinations,electrocardiograms (ECGs)and laboratory assessments.
During the study
To determine the effects of repeated doses of AZD7325 on the pharmacokinetic profile of a CYP3A4 substrate (midazolam and its 1' hydroxy metabolite) and a CYP1A2 substrate (caffeine and its paraxanthine [3-desmethyl] metabolite).
Blood samples will be taken during the study.
Evaluation of the pharmacodynamic effects of AZD6280 by central nervous system function tests.
Test batteries will be performed at specified times both before and following study drug administration.
To assess the safety and tolerability of multiple ascending oral doses of AZD7325 compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, and ECGs
Alssessments are made at each visit, at least daily, during the study.
Secondary Endpoints
Pharmacokinetic parameters for AZD7325
During residential period
Genetic analysis of the genes involved in the pharmacokinetics and safety and tolerability to AZD7325 treatment may be performed. Participation in the exploratory genetic study is optional for the subjects.
During the study
To evaluate the safety and tolerability of repeated doses of AZD7325 in combination with midazolam and caffeine.
Blood samples will be taken during the study.
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
3OTHERAZD7325 Placebo/Lorazepam 1 mg combination therapy; washout period; AZD7325 Placebo/Lorazepam Placebo combination therapy; washout period; AZD7325 1 mg/Lorazepam Placebo combination therapy; washout period; AZD7325 10 mg/Lorazepam Placebo combination therapy
4OTHERAZD7325 1 mg/Lorazepam Placebo combination therapy; washout period; AZD7325 Placebo/Lorazepam 1 mg combination therapy; washout period; AZD7325 10 mg/Lorazepam Placebo combination therapy; washout period; AZD7325 Placebo/Lorazepam Placebo combination therapy
Interventions
NameTypeDescription
AZD7325DRUGCapsule for oral, single dose
PlaceboDRUGPlacebo capsule for oral, single dose
MidazolamDRUGsingle dose, twice during treatment
CaffeineDRUGsingle dose, twice during treatment
LorazepamDRUGLorazepam 1 mg oral 2 tablets
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Eligibility Criteria
Age Range20 Years — 50 Years
SexMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Body mass index (BMI) : 18 to 27 kg/m 2 Exclusion Criteria: * Clinically relevant disease and/or abnormalities (past or present) * Clinically relevant abnormalities in physical examinations,vital signs,clinical chemistry, hematology or urinalysis at screening as judged by th...

Countries:United StatesNetherlands
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