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

AstraZeneca

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Participants

Treatments: Drug: AZD4144; Drug: Omeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT06948006

D9441C00003

Details and patient eligibility

About

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.

Full 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

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Signed the informed consent form before any study-related procedure.
2. Healthy male and female participants with suitable veins for cannulation or repeated venipuncture.
3. Negative pregnancy test for females at screening, first admission, and follow-up.
4. Females of childbearing potential must use highly effective contraception from first dose until 3 months after last dose.
5. Non-childbearing potential females must meet postmenopausal or surgical sterilization criteria.
6. Sexually active fertile males must use contraception from first dose until 3 months after last dose.
7. Body Mass Index (BMI) between 18-32 kg/m2 and weight ≥45 kg at screening and first admission.

Exclusion criteria

1. History of any clinically important disease or disorder that may put the participant at risk or influence study results.
2. History or presence of gastrointestinal, hepatic, or renal disease or any condition affecting drug absorption, distribution, metabolism, or excretion.
3. Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of randomization.
4. Active systemic bacterial, viral, or fungal infection within 14 days prior to dosing or presence of fever within 14 days prior to dosing.
5. Clinically significant serious active and chronic infections within 60 days prior to randomization.
6. Any history or evidence of tuberculosis (TB) (active or latent) using TB-QuantiFERON tests during screening.
7. Clinical signs and symptoms consistent with coronavirus disease 2019 (COVID-19).
8. Known history of primary immunodeficiency or an underlying condition that predisposes to infection.
9. Positive result for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV).
10. Plasma donation within one month of the screening visit or any blood donation/blood loss > 500 mL during the 3 months prior to the screening visit.
11. Participants who have previously received AZD4144.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Arm 1: AZD4144

Experimental group

Description:

Participants will receive single doses of AZD4144 dose 1 as tablet formulation (Treatments A and B) and as an oral solution formulation (Treatment C) under fasted (Treatments A and C) and fed (Treatment B) conditions.

Treatment:

Drug: AZD4144

Arm 2: AZD4144 + Omeprazole

Experimental group

Description:

Participants will receive single doses of AZD4144 dose 2 tablet formulation under fasted (Treatment D) and fed (Treatment E) conditions and co-administered with omeprazole (Treatment F).

Treatment:

Drug: Omeprazole

Drug: AZD4144