A Study to Investigate the Effect of AZD5004 on Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and the Effect of Erythromycin on AZD5004 in Healthy Participants
brief summary
This study will assess the effect of AZD5004 on Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and the effect of Erythromycin on AZD5004 in healthy adult male and female participants.
detailed description
This is a Phase I, open-label, fixed-sequence, single center study which consists of 3 parts: Part A, Part B and Part C. Part A, Part B, and Part C are 3 independent and non-sequential parts in this study.
The purpose of Part A (Rosuvastatin and Erythromycin) of this study is to measure the following in healthy male and female participants,
1. The impact of AZD5004 on the pharmacokinetics (PK: the way the body absorbs, distributes, metabolizes, and eliminates a medicine) of rosuvastatin and 2. The impact of erythromycin on the PK of AZD5004
The purpose of Part B (Atorvastatin and Simvastatin) of this study is to measure the impact of AZD5004 on the PK of atorvastatin and simvastatin in healthy male and female participants.
The purpose of Part C (Repaglinide) of this study is to measure the impact of AZD5004 on the PK of repaglinide in healthy male and female participants.
Part A will consist of a screening period, 8 treatment periods, and a follow-up period.
Part B will consist of a screening period, 7 treatment periods, and a follow-up period.
Part C will consist of a screening period, 4 treatment periods, and a follow-up period.
official title
An Open-label, Fixed-sequence, Three-part Study to Assess the Effect of AZD5004 on the Pharmacokinetics of Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and to Assess the Effect of Erythromycin on AZD5004 in Healthy Participants