NCT06948747

A Study to Investigate the Effect of AZD5004 on Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and the Effect of Erythromycin on AZD5004 in Healthy Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	AZD5004	Participants will receive oral tablets of AZD5004 as single dose on the following days, (i) Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 and Day 55 in Part A. (ii) Day 9 to Day15, Day 16, Day 17 to Day 23, Day 24 to Day 30, Day 31 to Day 37, Day 38 to Day 41 and Day 42 in Part B. (iii) Day 3 to Day 9, Day 10 to Day 25, Day 26 to Day 33, and Day 34 in Part C.
DRUG	Rosuvastatin	Participants will receive single oral tablets of rosuvastatin 10mg on Days 1, 7, 14, 21, 28, and 35.
DRUG	Erythromycin	Participants will receive oral doses of erythromycin 500 mg, twice a day from Day 49 to Day 54; and a single dose of 500 mg on Day 55.
DRUG	Atorvastatin	Participants will receive single oral doses of 40 mg atorvastatin on Days 4, 8, 16, 38, and 42.
DRUG	Simvastatin	Participants will receive single oral doses of 20 mg simvastatin on Days 1 and 31.
DRUG	Repaglinide	Participants will receive single oral doses of 0.5 mg repaglinide on Days 1, 10, 26, and 34.

Timeline

• Start date: 2025-05-06
• Primary completion: 2025-10-03
• Completion: 2025-10-03
• First posted: 2025-04-29
• Last updated: 2025-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study