NCT04734275

Study to Assess Relative Bioavailability and Safety of AZD5718 in Healthy Volunteers

A Randomised, Single-dose, Open-label, Single-centre, Crossover Study to Assess the Relative Bioavailability and Safety of Different Formulations of AZD5718 in Fasted and Fed State in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will be a randomised, open-label, 3-period, 3-treatment, single-dose, crossover study in healthy subjects The study will be performed at a single study centre in the United Kingdom.

Detailed description

The study will comprise: * A screening period of maximum 28 days; * 3 treatment periods during which subjects will be resident at the Clinical Unit from the day before dosing with AZD5718 (Day -1) until at least 48 hours after dosing (Day 3), with discharge on the morning of Day 3 of each treatment period; and * A final visit within 5 to 7 days after the last administration of AZD5718. Subjects will receive single doses of AZD5718 on 3 occasions, separated by at least 7 days washout, under fasted and fed conditions. Two different formulations (Test Formulation and Reference Formulation) will be given in a randomised order: * Treatment A (Test Formulation): AZD5718 Dose A, fasted * Treatment B (Test Formulation): AZD5718 Dose A, fed * Treatment C (Reference Formulation): AZD5718 Dose A, fasted

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	AZD5718	Subjects will receive single doses of AZD5718 on 3 occasions, separated by at least 7 days washout, under fasted and fed conditions.

Timeline

• Start date: 2021-02-01
• Primary completion: 2021-03-25
• Completion: 2021-03-25
• First posted: 2021-02-02
• Last updated: 2021-12-06

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study