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AZD5718 IR

Phase 1

High Risk Coronary Artery Disease | Small molecule | Cardiovascular |AstraZeneca PLC|Last Updated: Mar 9, 2017

Success Probability

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

AZD5718 IR · 1 trial · 1 indication

Phase 1 1
NCT02963116A Study to Estimate the Effect of AZD5718 on the Pharmacokinetics (What Does the Body Does to the Drug) of Rosuvastatin to Measure the Relative Bioavailability (the Extent to Which a Drug or Other Substance Becomes Available to the Body) of AZD5718 Oral Suspension vs AZD5718 Immediate Release TabletHigh Risk Coronary Artery Disease
COMPLETED12 Analytics
PHASE1COMPLETED
A Study to Estimate the Effect of AZD5718 on the Pharmacokinetics (What Does the Body Does to the Drug) of Rosuvastatin to Measure the Relative Bioavailability (the Extent to Which a Drug or Other Substance Becomes Available to the Body) of AZD5718 Oral Suspension vs AZD5718 Immediate Release Tablet
High Risk Coronary Artery DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Assessment of AUC of rosuvastatin when administered alone and in combination with AZD5718 in healthy volunteers.

Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-last)] of Rosuvastatin
Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose

Assessment of AUC(0-last) of rosuvastatin when administered alone and in combination with AZD5718 in healthy volunteers.

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

Assessment of Cmax of rosuvastatin when administered alone and in combination with AZD5718 in healthy volunteers.

Secondary Endpoints

Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½) of Rosuvastatin -
Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose. (Only Treatment A and B)
Time to reach maximum observed plasma concentration (tmax) of rosuvastatin
Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose. (Only Treatment A and B)
AUC of AZD5718
Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose (Only Treatment B, C, D, and E)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Treatment AEXPERIMENTAL10 mg rosuvastatin tablet alone (fasting state)
Treatment BEXPERIMENTAL10 mg rosuvastatin tablet + 200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fasting state)
Treatment CEXPERIMENTAL200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fasting state)
Treatment DEXPERIMENTAL200 mg of AZD5718 oral suspension 50 mg/mL (fasting state)
Treatment EEXPERIMENTAL200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fed state)

Interventions

NameTypeDescription
AZD5718 IR tabletDRUG -
AZD5718 oral suspensionDRUG -
Rosuvastatin tabletDRUG -
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: For inclusion in the study, subjects should fulfill the following criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures. 2. Healthy male and/or female subjects (of non childbearing potential) aged 18 to 50 years (inclusive) ...

Countries:United Kingdom
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Frequently asked questions about AZD5718 IR

What is AZD5718 IR used for?

AZD5718 IR is an investigational small molecule being developed for high risk coronary artery disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in a clinical trial setting to evaluate its effects and pharmacokinetics in patients with this condition.

Who makes AZD5718 IR?

AZD5718 IR is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical research on this investigational drug for the treatment of high risk coronary artery disease.

What phase is AZD5718 IR in?

AZD5718 IR is currently in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. The Phase 1 trial has been completed, and the drug remains under investigation for its potential use in high risk coronary artery disease.

What clinical trials is AZD5718 IR in?

AZD5718 IR has one completed Phase 1 clinical trial registered under NCT02963116. This study evaluated the effect of AZD5718 on the pharmacokinetics of rosuvastatin and compared the relative bioavailability of AZD5718 oral suspension versus the immediate release tablet. The trial enrolled 12 participants in the United Kingdom.

Is AZD5718 IR the same as AZD5718 oral suspension?

AZD5718 IR refers to the immediate release tablet formulation of the drug AZD5718, while AZD5718 oral suspension is a different formulation. A clinical trial has been conducted to measure the relative bioavailability of the oral suspension compared to the immediate release tablet, indicating they are distinct formulations of the same drug.