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

Chronic Kidney Disease Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

• NCT number: NCT04734275
• Study type: Interventional
• Source: AstraZeneca
• Status: Completed
• Phase: Phase 1
• Start date: February 1, 2021
• Completion date: March 25, 2021