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Form 1 of AZD5718

Phase 1

Coronary Artery Disease | Small molecule | Cardiovascular |AstraZeneca PLC|Trials Updated: Apr 23, 2018

Form 1 of AZD5718 target and mechanism

ModalitySmall molecule

Also known as Form 1 of AZD5718 tablets

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Form 1 of AZD5718 clinical trials

Form 1 of AZD5718 · 1 trial · 1 indication

Phase 1 1
NCT03420092A Study to Assess the Bioavailability of Different Formulations of AZD5718 and the Food Effect on the Selected Formulation of AZD5718 in Healthy VolunteersCoronary Artery Disease
COMPLETED14 Analytics
PHASE1COMPLETED
A Study to Assess the Bioavailability of Different Formulations of AZD5718 and the Food Effect on the Selected Formulation of AZD5718 in Healthy Volunteers
Coronary Artery DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Area under plasma concentration-time curve (AUC) of AZD5718
At pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours post dose.

To assess the pharmacokinetics (PK) parameter AUC to evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation (Form 1 of AZD5718 tablets) used in the Phase 2a clinical study.

AUC from time zero to time of last quantifiable concentration (AUC[0-t]) of AZD5718
At pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours post dose.

To assess the PK parameter AUC(0-t)to evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation (Form 1 of AZD5718 tablets) used in the Phase 2a clinical study.

Observed maximum plasma concentration (Cmax) of AZD5718
At pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours post dose.

To assess the PK parameter Cmax to evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation (Form 1 of AZD5718 tablets) used in the Phase 2a clinical study.

Observed plasma concentration at 24 hours post dose (C24) of AZD5718
24 hour post dose

To assess the PK parameter C24 to evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation (Form 1 of AZD5718 tablets) used in the Phase 2a clinical study.

Secondary Endpoints

Cmax of AZD5718 in fed and fasted conditions
At pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours post dose.
C24 of AZD5718 in fed and fasted conditions
At pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours post dose.
AUC(0-t) of AZD5718 in fed and fasted conditions
At pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours post dose.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment AEXPERIMENTALThe participant will be administered with Form 1 of AZD5718 tablets with an overnight fast of at least 10 hours.
Treatment BEXPERIMENTALThe participant will be administered with Form 2 of AZD5718 tablets with an overnight fast of at least 10 hours.
Treatment CEXPERIMENTALThe participant will be administered with Form 3 of AZD5718 tablets with an overnight fast of at least 10 hours.
Treatment DEXPERIMENTALThe participant will be administered with Form 4 of AZD5718 tablets with an overnight fast of at least 10 hours.
Treatment EEXPERIMENTALThe participant will be administered with Form 5 of AZD5718 tablets with an overnight fast of at least 10 hours.
Treatment FEXPERIMENTALThe participant will be administered with selected form (one of Form 2-5) of AZD5718 tablets 30 minutes after start of the meal.

Interventions

NameTypeDescription
Form 1 of AZD5718 tabletsDRUGThe participants will be dosed with Form 1 of AZD5718 following an overnight fast of at least 10 hours.
Form 2 of AZD5718 tabletsDRUGThe participants will be dosed with Form 2 of AZD5718 following an overnight fast of at least 10 hours.
Form 3 of AZD5718 tabletsDRUGThe participants will be dosed with Form 3 of AZD5718 following an overnight fast of at least 10 hours.
Form 4 of AZD5718 tabletsDRUGThe participants will be dosed with Form 4 of AZD5718 following an overnight fast of at least 10 hours.
Form 5 of AZD5718 tabletsDRUGThe participants will be dosed with Form 5 of AZD5718 following an overnight fast of at least 10 hours.
Selected form (Form 2 - 5) of AZD5718 tabletsDRUGThe participant will be administered with selected form (one of Form 2-5) of AZD5718 tablets 30 minutes after start of the meal.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Provision of signed and dated, written informed consent before any study specific procedures. 2. Healthy male and/or female subjects aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture. 3. Females must have a negative pregnancy test at...

Countries:United Kingdom
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Frequently asked questions about Form 1 of AZD5718

What is Form 1 of AZD5718?

Form 1 of AZD5718 is a specific tablet formulation of AZD5718, a small molecule under development by AstraZeneca PLC for coronary artery disease. It has been studied in a Phase 1 clinical trial to assess bioavailability and food effects. The drug is investigational and has not been approved for any indication.

What is Form 1 of AZD5718 used for?

Form 1 of AZD5718 is being developed for the treatment of coronary artery disease. It is an investigational therapy and has not been approved for any use. The clinical program is in Phase 1, focusing on early-stage evaluation in healthy volunteers.

Who makes Form 1 of AZD5718?

Form 1 of AZD5718 is developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the clinical trial evaluating this formulation.

What phase is Form 1 of AZD5718 in?

Form 1 of AZD5718 is in Phase 1 clinical development. The only reported trial is a completed Phase 1 study. It is investigational and has not received FDA approval.

What clinical trials is Form 1 of AZD5718 in?

Form 1 of AZD5718 has been evaluated in one completed Phase 1 trial, NCT03420092, titled "A Study to Assess the Bioavailability of Different Formulations of AZD5718 and the Food Effect on the Selected Formulation of AZD5718 in Healthy Volunteers." The trial enrolled 14 healthy volunteers in the United Kingdom.

Is Form 1 of AZD5718 the same as Form 1 of AZD5718 tablets?

Yes, Form 1 of AZD5718 tablets is another name for Form 1 of AZD5718. Both refer to the same tablet formulation developed by AstraZeneca PLC for coronary artery disease.