A Study to Assess the Drug Absorption Into the Blood After Administration of 3 Doses of AZD5718

2019-09-18 03:27:52 | BioPortfolio


This study will be conducted to evaluate the AZD5718 pharmacokinetic (PK) doses in order to determine exposure in a new dose range and compare with previous results. This study will include 14 subjects in a single site in United Kingdom. Each subject will be involved in the study for 6 to 7 weeks.


This study will be an open-label, randomized, 3-period, 3-treatment, crossover study performed in healthy subjects at a single study center.

A total of 14 healthy male and female subjects (of no childbearing potential) will be randomized to ensure that at least 12 subjects are evaluable. Each subject will receive 3 different treatments at least 4 days apart and will be dosed following an overnight fast of at least 10 hours. The following treatments will be given:

- Treatment A: AZD5718 Dose A tablet

- Treatment B: AZD5718 Dose B tablet

- Treatment C: AZD5718 Dose C tablet

The study will comprise:

- A Screening Period of maximum 28 days.

- Three Treatment Periods during which subjects will be resident from the day before first dosing with AZD5718 (Day -1) in Treatment Period 1 until at least 48 hours after last dosing with AZD5718 in Treatment Period 3 for collection of PK and safety samples. Subjects will be discharged on Day 3 of Treatment Period 3.

- A Follow up Visit, 5 to 7 days after the last dose of investigational medicinal product (IMP).

There will be a minimum washout period of 4 days between each dose administration.

Each subject will be involved in the study for 6 to 7 weeks. This study will be conducted in male and female subjects aged 18 to 55 years.

Study Design


Coronary Artery Disease


Treatment A, Treatment B, Treatment C


Research Site
United Kingdom


Not yet recruiting



Results (where available)

View Results


Published on BioPortfolio: 2019-09-18T03:27:52-0400

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