Coronary Artery Disease Clinical Trial
Official title:
A Randomized, 3-period, 3-treatment, Single-dose, Open-label, Single-center, Crossover Study to Assess the Pharmacokinetics of 3 Doses of AZD5718
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.
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