A Study to Assess the Effect of Multiple Doses of AZD5462 on the Pharmacokinetics (PK) of Drugs in Healthy Participants

• Status: Not yet recruiting
• Trial end date: 2022-09-06

Summary

This study will assess the effect of multiple doses of AZD5462 on the PK of oral midazolam (CYP3A4 probe), rosuvastatin (OATP1B1/3, BCRP probe), and digoxin (P-gp probe) in healthy participants.

This study will consist of 2 treatment arms (Treatment Arms A and B) and within each treatment arm, the participants will first be administered the probe substrates (midazolam, rosuvastatin, and digoxin) alone followed by administration of the probe substrates together with AZD5462. The treatment arms differ in the dose of AZD5462 being administered and will be performed sequentially starting with Treatment Arm A (AZD5462 Dose A, high dose treatment arm) and followed by Treatment Arm B (AZD5462 Dose B, low dose treatment arm). Each treatment arm will include 5 periods.

Thirty two participants in total (16 participants per treatment arm) will be enrolled to ensure at least 24 evaluable participants (12 participants per treatment arm) at the end of the last treatment period.

A follow-up visit at Day 24 (+-1 Day) will be conducted via a phone call.

• Phase: Phase 1

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Parexel
• Treatments: Digoxin; Midazolam; Rosuvastatin Calcium