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Form 1 of AZD5718

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

Form 1 of AZD5718 is an investigational small molecule being developed by AstraZeneca for Coronary Artery Disease. It is currently in Phase 1 clinical development, meaning it has not been approved and is still being studied for safety and tolerability in early-stage trials.

Who makes Form 1 of AZD5718?

Form 1 of AZD5718 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The drug is a small molecule intended for the treatment of Coronary Artery Disease and is currently in Phase 1 clinical trials.

What phase is Form 1 of AZD5718 in?

Form 1 of AZD5718 is in Phase 1 clinical development. It is an investigational drug, meaning it is not yet approved for use. The Phase 1 trial has been completed, and the drug is being studied for its bioavailability and food effects in healthy volunteers.

What clinical trials is Form 1 of AZD5718 in?

Form 1 of AZD5718 has one completed Phase 1 clinical trial, identified as NCT03420092. This study assessed the bioavailability of different formulations of AZD5718 and the food effect on the selected formulation in healthy volunteers. The trial enrolled 14 participants and was conducted in the United Kingdom.

Is Form 1 of AZD5718 the same as AZD5718?

Yes, Form 1 of AZD5718 is a specific formulation of the drug AZD5718. The clinical trial NCT03420092 was designed to compare different formulations of AZD5718, including Form 1, to evaluate their bioavailability and how food affects the selected formulation in healthy volunteers.