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AZD3043

Phase 1

Healthy | 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
RandomizedCONTROLLEDBiomarker
Total Trials3
Total Enrollment197
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01028040AZD Single Ascending Dose Study In Healthy Japanese SubjectsPHASE1 COMPLETED 72 — — Dec 1, 2009Aug 1, 2010Dec 10, 20101 United Kingdom
NCT00984880Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3043PHASE1 COMPLETED 72 — — Sep 1, 2009Dec 1, 2009Dec 18, 20091 Sweden
NCT00918515Study to Assess the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of AZD3043PHASE1 COMPLETED 53 — — May 1, 2009Aug 1, 2009Aug 28, 20091 Sweden
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Study Endpoints
Primary Endpoints
To assess the safety and tolerability of AZD3043 following administration of SAD bolus (Part A) and SAD bolus followed by infusion (Part B).
From screening period to follow-up visit 42 days (Maximum)
Assessment of vital signs data, heart rate, ECG
The measure will be taken between -20 to 120 min relative to stop of administration of AZD3043
Respiratory signs data (SpO2, EtCO2, PaO2, blood gases, respiratory frequency and pattern, occurrence of apnoea)
The measure will be taken between -20 to 120 min relative to stop of administration of AZD3043
Assessment of Vital signs data, heart rate, electrocardiogram (ECG)
The measure will be taken between -20 to 150 min relative to start of administration of AZD3043.
Respiratory signs data (SpO2, EtCO2, PaO2, blood gases, respiratory frequency, volume and pattern, occurrence of apnoea;
The measure will be taken between -20 to 150 min relative to start of administration of AZD3043.
Secondary Endpoints
To characterize the PK of AZD3043 and its main metabolite (THRX-108893) & provisionally assess the dose-proportionality of the PK
Blood and urine sampling from pre-dose until follow-up visit, 10 days (approximately)
To evaluate the onset, level and recovery of/from sedation/anaesthesia.
Assessed on Day 1
PK parameters for AZD3043: Cmax (in part B: bolus Cmax and infusion Cmax), AUClast, AUC, lz, t½lz, CL, Vc, Vss, Vz, tmax, tlast and MRT arterial and venous plasma.
Part A: Arterial: Predose and continously up to 120 min after start of dosing. Part B: Arterial: Predose and continously up to 150 min after start of dosing. Venous: Predose and continously up to 24 h after start of dosing
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
AZD3043EXPERIMENTAL -
1EXPERIMENTALIntravenous solution given as a single ascending bolus dose
2EXPERIMENTALIntravenous solution given as a single ascending bolus dose followed by a single infusion
Interventions
NameTypeDescription
AZD3043DRUGIntravenous, single dose
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Eligibility Criteria
Age Range20 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Japanese male and females of non-childbearing potential aged ≥20 to ≤ 45 with suitable veins for cannulation or repeated venepuncture. * Body weight 45-90 kg and Body mass index (BMI) ≥18.0 and ≤27.0 kg/m2 * Clinically normal physical findings including supine blood pr...

Countries:United KingdomSweden
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