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Part A

Phase 1

Gonococcal (GC) Infection | Small molecule | Other |AstraZeneca PLC|Last Updated: Apr 15, 2014

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 Trials1
Total Enrollment100
FDA Designations
PRIORITY_REVIEWBREAKTHROUGH_THERAPYFAST_TRACK
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01929629A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD0914PHASE1 COMPLETED 100 — — Sep 1, 2013Mar 1, 2014Apr 15, 20141 United States
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Study Endpoints
Primary Endpoints
Description of the safety profile in terms of adverse events; blood pressure, heart rate and body temperature; electrocardiograms; telemetry; clinical chemistry ; haematology and physical examination
From admission on day -1 until follow up. ( Max 16 days)

Applies to Part A and B

Secondary Endpoints
Description of pharmacokinetics(PK) for AZD0914 study part A and B in terms of maximum observed plasma concentration (Cmax)
Samples taken at predose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose
Description of pharmacokinetics(PK) for AZD0914 study part A and B in terms of time to reach maximum observed plasma concentration (tmax)
Samples taken at predose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose
Description of pharmacokinetics(PK) for AZD0914(Part A and B) in terms of AUC from time zero to time of last quantifiable AZD0914 concentration [AUC(0-last)]
Samples taken at predose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Placebo fastingPLACEBO_COMPARATORSingle or multiple dosing placebo
Active fed conditionEXPERIMENTALAZD0914 given as single dose
Interventions
NameTypeDescription
Part ADRUGSingle ascending doses
Part BDRUGSingle doses food effect. Subjects to receive 2 single doses, one in fed and one in fasted.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female (of non-childbearing potential)subjects aged 18 to55 years (inclusive). * Have a body mass index (BMI) between 18.00 and 30.50 kg/m2 and weigh at least 50 kg and no more than 100 kg * Male subjects should be willing to use barrier contraception, ie, con...

Countries:United States
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