Study identifier:D9090C00003
ClinicalTrials.gov identifier:NCT05395117
EudraCT identifier:N/A
CTIS identifier:N/A
A fixed sequence, open-label study to assess the effect of multiple doses of AZD5462 on the pharmacokinetics of oral midazolam (CYP3A4 probe), rosuvastatin (OATP1B1/3, BCRP probe), and digoxin (P-gp probe) in healthy participants
Healthy Participants
Phase 1
Yes
AZD5462, Midazolam, Rosuvastatin, Digoxin
All
32
Interventional
18 Years - 55 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
PAREXEL
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Treatment Arm A: High dose Participants will receive the Investigational Medicinal Product (IMP), AZD5462 Dose A starting on Day 6 and continued until Day 18 and the following approved medicinal products: - Midazolam - Rosuvastatin - Digoxin | Drug: AZD5462 Treatment Arm A: Participants will receive the IMP, AZD5462 Dose A starting on Day 6 and continued until Day 18 and the following approved medicinal products: - Midazolam - Rosuvastatin - Digoxin Treatment Arm B: Participants will receive the IMP, AZD5462 Dose B starting on Day 6 and continued until Day 18 and the following approved medicinal products: - Midazolam - Rosuvastatin - Digoxin Drug: Midazolam Participants will receive a single dose of midazolam in the morning of Day 1 and in the morning of Day 15 in both the arms. Drug: Rosuvastatin Participants will receive rosuvastatin as a single dose administered with digoxin at the same time in the morning of Day 2, Day 6, and in the morning of Day 16 in both the arms. Drug: Digoxin Participants will receive digoxin as a single dose administered with rosuvastatin at the same time in the morning of Day 2, Day 6, and in the morning of Day 16 in both the arms. |
Experimental: Treatment Arm B: Low dose Participants will receive the IMP, AZD5462 Dose B starting on Day 6 and continued until Day 18 and the following approved medicinal products: - Midazolam - Rosuvastatin - Digoxin | Drug: AZD5462 Treatment Arm A: Participants will receive the IMP, AZD5462 Dose A starting on Day 6 and continued until Day 18 and the following approved medicinal products: - Midazolam - Rosuvastatin - Digoxin Treatment Arm B: Participants will receive the IMP, AZD5462 Dose B starting on Day 6 and continued until Day 18 and the following approved medicinal products: - Midazolam - Rosuvastatin - Digoxin Drug: Midazolam Participants will receive a single dose of midazolam in the morning of Day 1 and in the morning of Day 15 in both the arms. Drug: Rosuvastatin Participants will receive rosuvastatin as a single dose administered with digoxin at the same time in the morning of Day 2, Day 6, and in the morning of Day 16 in both the arms. Drug: Digoxin Participants will receive digoxin as a single dose administered with rosuvastatin at the same time in the morning of Day 2, Day 6, and in the morning of Day 16 in both the arms. |