NCT03400488

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5718 After Single and Multiple Ascending Dose Administration to Healthy Japanese Men

Completed Phase 1 Last updated 15 June 2018

What this trial tests

Phase 1 trial testing AZD5718 oral suspension in Coronary Artery Disease in 32 participants. Completed in 12 June 2018.

Timeline

16 January 2018

Primary endpoint
12 June 2018

12 June 2018

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	32
Start date	16 January 2018
Primary completion	12 June 2018
Estimated completion	12 June 2018
Sites	1 location across United States

Drugs / interventions tested

• AZD5718 oral suspension
• Placebo matching AZD5817 oral suspension

Conditions studied

• Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 50, male only, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase I study to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of the novel compound, AZD5718 in healthy Japanese men. The results from this study will form the basis for decisions on future studies.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pharmacokinetics, Pharmacodynamics, and Tolerability of AZD5718, an Oral 5-Lipoxygenase-Activating Protein (FLAP) Inhibitor, in Healthy Japanese Male Subjects.
   Knöchel J, Nelander K, Heijer M, Lindstedt EL, et al · · 2021 · cited 3× · PMID 34546534 · DOI 10.1007/s40261-021-01078-7