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AZD5718, Formulation A

Phase 1

Coronary Artery Disease (CAD) | Small molecule | Cardiovascular |AstraZeneca PLC|Last Updated: Mar 25, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

AZD5718, Formulation A · 1 trial · 1 indication

Phase 1 1
NCT04210388A Study to Assess the Amount of Drug Levels in Blood and Safety of AZD5718 Formulations in Healthy VolunteersCoronary Artery Disease (CAD)
COMPLETED12 Analytics
PHASE1COMPLETED
A Study to Assess the Amount of Drug Levels in Blood and Safety of AZD5718 Formulations in Healthy Volunteers
Coronary Artery Disease (CAD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Area under the plasma concentration-time curve from zero to infinity (AUC)
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose

To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers

Area under the plasma concentration-curve from time zero to time of last quantifiable concentration (AUClast)
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose

To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers

Maximum observed plasma concentration (Cmax)
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose

To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers

Drug concentration at 24 hours after dosing (C24)
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose

To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers

Time to reach maximum observed plasma concentration (tmax)
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose

To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers

Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz)
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose

To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers

Terminal elimination rate constant (λz)
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose

To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers

Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose

To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers

Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose

To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers

Dose normalized AUC (AUC/D)
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose

To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers

Dose normalized AUClast (AUClast/D)
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose

To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers

Dose normalized Cmax (Cmax/D)
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose

To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers

Dose normalized C24 (C24/D)
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose

To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers

Secondary Endpoints

Number of volunteers with having adverse events and/or abnormal findings in vital signs and/or clinical laboratory assessments and/or physical examination and/or electrocardiogram (ECG) evaluation and/or body weight
From Screening up to 9 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AZD5718 tablet, Treatment AEXPERIMENTALVolunteers will receive single doses of AZD5718 tablet, Formulation A under fasted conditions.
AZD5718 tablet, Treatment BEXPERIMENTALVolunteers will receive single doses of AZD5718 tablet, Formulation B under fasted conditions.
AZD5718 tablet, Treatment CEXPERIMENTALVolunteers will receive single doses of AZD5718 tablet, Formulation C under fasted conditions.
AZD5718 tablet, Treatment DEXPERIMENTALVolunteers will receive single doses of AZD5718 tablet, Formulation C under fasted conditions.
AZD5718 film-coated tabletACTIVE_COMPARATORVolunteers will receive single doses of AZD5718 film-coated tablet, Reference treatment under fasted conditions.

Interventions

NameTypeDescription
AZD5718 tablet, Formulation ADRUGVolunteers will receive single doses of AZD5718 tablet, Formulation A under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours.
AZD5718 tablet, Formulation BDRUGVolunteers will receive single doses of AZD5718 tablet, Formulation B under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours.
AZD5718 tablet, Formulation CDRUGVolunteers will receive single doses of AZD5718 tablet, Formulation C under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours.
AZD5718 tablet, Formulation DDRUGVolunteers will receive single doses of AZD5718 tablet, Formulation D under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours.
AZD5718 film-coated tablet, Reference treatmentDRUGVolunteers will receive single doses of AZD5718 film-coated tablet, Reference treatment under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: For inclusion in the study volunteers should fulfill the following criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures. * Healthy male or female volunteers aged 18 to 55 years (inclusive at screening) with suitable veins fo...

Countries:United Kingdom
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Frequently asked questions about AZD5718, Formulation A

What is AZD5718 used for?

AZD5718 is an investigational small molecule being developed by AstraZeneca for cardiovascular and kidney conditions, including coronary artery disease, chronic kidney disease, and cardiovascular disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes AZD5718?

AZD5718 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker AZN. The drug is in early-stage clinical development, with Phase 1 trials completed.

What phase is AZD5718 in?

AZD5718 is in Phase 1 clinical development. All completed trials for the drug are Phase 1 studies, and it remains investigational, meaning it has not received regulatory approval for any indication.

What clinical trials has AZD5718 been in?

AZD5718 has been studied in several completed Phase 1 trials, including NCT03400488, which assessed safety and tolerability in healthy Japanese men, and NCT03948451, a mass balance study. Other trials include NCT04210388, evaluating drug levels and safety of different formulations, and NCT04492709, a drug interaction study with midazolam.

Is AZD5718 being studied in healthy volunteers?

Yes, all completed clinical trials for AZD5718 have enrolled healthy volunteers. These include studies in healthy Japanese men, healthy male volunteers in the United Kingdom, and trials open to all sexes, with the goal of assessing safety, pharmacokinetics, and drug interactions.