A Study to Estimate the Effect of AZD5718 on the Pharmacokinetics (What Does the Body Does to the Drug) of Rosuvastatin to Measure the Relative Bioavailability (the Extent to Which a Drug or Other Substance Becomes Available to the Body) of AZD5718 Oral Suspension vs AZD5718 Immediate Release Tablet

Summary

This study is a randomized, open-label, 5-period, 5-treatment, single-dose, single-center, crossover study to estimate the effect of AZD5718 on the pharmacokinetics (PK) of rosuvastatin, and to assess the relative bioavailability of AZD5718 oral suspension vs AZD5718 immediate release (IR) Tablet Formulation and the Food Effect of AZD5718 in Healthy Volunteers. The study will be performed at a single study center.

Timeline

Start

2016-12-20

Primary completion

2017-03-01

Completion

2017-03-01

Publications

• Ericsson H, Nelander K, Heijer M, Kjaer M, Lindstedt EL, Albayaty M, Forte P, Lagerstrom-Fermer M, Skrtic S. Phase 1 Pharmacokinetic Study of AZD5718 in Healthy Volunteers: Effects of Coadministration With Rosuvastatin, Formulation and Food on Oral Bioavailability. Clin Pharmacol Drug Dev. 2020 Apr;9(3):411-421. doi: 10.1002/cpdd.756. Epub 2019 Dec 2.

Drugs

Indications