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AZD3043

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Dec 10, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials3
Total Enrollment197

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

AZD3043 is an investigational small molecule being studied in healthy volunteers. It is in Phase 1 clinical development, with completed trials assessing its safety, tolerability, pharmacokinetics, and pharmacodynamics. It is not approved for any indication and remains in clinical development.

Who is developing AZD3043?

AZD3043 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company has sponsored Phase 1 clinical trials of the drug in healthy volunteers.

What phase is AZD3043 in?

AZD3043 is in Phase 1 clinical development. All three of its clinical trials are Phase 1 studies and have been completed. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is AZD3043 in?

AZD3043 has been studied in three completed Phase 1 trials: NCT00918515, NCT00984880, and NCT01028040. These trials enrolled a total of 197 healthy volunteers and assessed safety, tolerability, pharmacokinetics, and pharmacodynamics.

Is AZD3043 the same as any other drug?

AZD3043 is the primary name used for this investigational drug in clinical trial records. No alternative names have been reported for this compound in the available data.