NCT04210388

A Study to Assess the Amount of Drug Levels in Blood and Safety of AZD5718 Formulations in Healthy Volunteers

A Randomized, Single-dose, Open-label, Single-center, Crossover Study to Assess the Relative Bioavailability and Safety of Different Formulations of AZD5718 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The study is a randomized, single-dose, open-label, combined 2x2 dose and 3x3 dose crossover design in fixed sequence. In this study, the relative bioavailability of different formulations of AZD5718 will be assessed in healthy volunteers in order to compare the exposure of Formulations A to D to the AZD5718 film-coated tablet formulation. The overall treatment period will start with a 2-period, 2-dose treatment crossover, followed by a 3-period, 3-dose treatment crossover.

Detailed description

This study will be conducted at a single study center in Parexel Early Phase Clinical Unit London. A total of 12 healthy male and female volunteers (of non-childbearing potential) will be randomized. The study will comprise: * A screening period of maximum 28 days * Five treatment periods * There will be a washout period of 3 to 6 days between dose administrations * Follow-up visit, 5 to 7 days after last dose Each volunteer will be involved in the study for between 7 and 9 weeks. The volunteers will be admitted to the Unit on the day before first dosing in Treatment Period 1 until at least 72 hours after last dosing in Treatment Period 5.

Conditions

• Coronary Artery Disease (CAD)

Interventions

Type	Name	Description
DRUG	AZD5718 tablet, Formulation A	Volunteers will receive single doses of AZD5718 tablet, Formulation A under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours.
DRUG	AZD5718 tablet, Formulation B	Volunteers will receive single doses of AZD5718 tablet, Formulation B under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours.
DRUG	AZD5718 tablet, Formulation C	Volunteers will receive single doses of AZD5718 tablet, Formulation C under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours.
DRUG	AZD5718 tablet, Formulation D	Volunteers will receive single doses of AZD5718 tablet, Formulation D under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours.
DRUG	AZD5718 film-coated tablet, Reference treatment	Volunteers will receive single doses of AZD5718 film-coated tablet, Reference treatment under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours.

Timeline

• Start date: 2020-01-14
• Primary completion: 2020-03-09
• Completion: 2020-03-09
• First posted: 2019-12-24
• Last updated: 2020-03-25

Locations

1 site across 1 country: United Kingdom