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AZD3043

Phase 1

Undisclosed | Small molecule | Other |AstraZeneca PLC|Trials Updated: Dec 10, 2010

AZD3043 development status

Highest phase Phase 1
Registered trials 4 across 1 sponsor since Jun 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials3
Total Enrollment197

FDA Designations

No designations recorded

AZD3043 clinical trials

AZD3043 · 3 trials · 1 indication

Phase 1 3
NCT01028040AZD Single Ascending Dose Study In Healthy Japanese SubjectsHealthy
COMPLETED72 Analytics
NCT00984880Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3043Healthy
COMPLETED72 Analytics
NCT00918515Study to Assess the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of AZD3043Healthy
COMPLETED53 Analytics
PHASE1COMPLETED
AZD Single Ascending Dose Study In Healthy Japanese Subjects
Healthy
NCT0102804072
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PHASE1COMPLETED
Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3043
Healthy
NCT0098488072
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PHASE1COMPLETED
Study to Assess the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of AZD3043
Healthy
NCT0091851553
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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 to 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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Frequently asked questions about AZD3043

What is AZD3043?

AZD3043 is an investigational small molecule developed by AstraZeneca PLC. It has been studied in Phase 1 clinical trials in healthy volunteers, with three completed studies enrolling a total of 197 participants. No approved indication has been disclosed for AZD3043.

Who makes AZD3043?

AZD3043 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company sponsored the Phase 1 clinical program for the compound.

What phase is AZD3043 in?

AZD3043 is in Phase 1 clinical development. All three of its trials are Phase 1 studies and all have been completed, with no active trials currently listed. It is an investigational agent and has not been approved for any indication.

What clinical trials is AZD3043 in?

AZD3043 has been evaluated in three completed Phase 1 trials: NCT01028040 in healthy Japanese subjects in the United Kingdom, NCT00984880 in healthy volunteers in Sweden, and NCT00918515 in healthy male volunteers in Sweden. Total enrollment across these studies was 197 participants.

What did the AZD3043 Phase 1 trials study?

The AZD3043 Phase 1 program assessed safety, tolerability, pharmacokinetics and pharmacodynamics in healthy volunteers. The studies were randomized and controlled, and were conducted in the United Kingdom and Sweden. NCT00984880 and NCT00918515 evaluated these parameters in healthy subjects, while NCT01028040 was a single ascending dose study in healthy Japanese subjects.

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