NCT06948006

A Study to Investigate the Relative Bioavailability of 2 Different Formulations of AZD4144, the Effect of Food and Omeprazole on the Pharmacokinetics of AZD4144 in Healthy Participants

An Open-label, Randomised, 2-arm, 3-period, 6-treatment Single-dose, Crossover Study Comparing the Pharmacokinetics of 2 Different Formulations of AZD4144, and Effect of Food and Omeprazole on the Pharmacokinetics of AZD4144 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main aim of this study to compare the pharmacokinetics (PK) of two formulations of AZD4144 and assess the effect of food and omeprazole on PK of AZD4144 in healthy participants.

Detailed description

This is an open-label, randomized, single-dose, crossover Phase I study. The study will comprise: 1. A Screening Period of 28 days. 2. Three Residential Periods 3. A final Follow-up period within 7 to 10 days after the last dose of study drug. There will be a minimum washout period of 7 days between each AZD4144 dose. This study includes the following 2 arms: Arm 1 consists of 3 treatments: 1. Treatment A: AZD4144 dose 1 as tablet (under fasted condition) 2. Treatment B: AZD4144 dose 1 as tablet (under fed condition) 3. Treatment C: AZD4144 dose 1 as an oral solution (under fasted condition) Arm 2 consists of 3 treatments: 1. Treatment D: AZD4144 dose 2 as tablet (under fasted condition) 2. Treatment E: AZD4144 dose 2 as tablet (under fed condition) 3. Treatment F: Omeprazole once daily for 4 days, followed by a single dose of omeprazole along with a single dose of AZD4144 dose 2 as tablet (under fasted condition). The participants will be randomised to one of the following treatment sequences: Arm 1: ABC, BCA or CAB Arm 2: DEF or EDF

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	AZD4144	Participants will receive AZD4144 orally.
DRUG	Omeprazole	Participants will receive omeprazole orally.

Timeline

• Start date: 2025-04-23
• Primary completion: 2025-06-27
• Completion: 2025-06-27
• First posted: 2025-04-28
• Last updated: 2025-07-23

Locations

1 site across 1 country: United Kingdom