RecruitingPhase 1NCT07455825

A Study to Investigate the Pharmacokinetics of Different Formulations and Safety of AZD5004 in Healthy Participants Aged 18 to 55 Years

A Phase I, Randomized, Single-dose, 3-Period, Open-Label Study to Assess the Pharmacokinetic Formulation Bridging, Safety, and Food Effect of Different Oral Formulations of AZD5004 in Healthy Participants


Sponsor

AstraZeneca

Enrollment

64 participants

Start Date

Mar 5, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to assess the pharmacokinetics (PK), safety and tolerability of different oral formulations of AZD5004, and to evaluate the effect of food on these formulations in healthy participants.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study examines how the body processes (pharmacokinetics) different forms or dosage formulations of an experimental drug called AZD5004. Healthy volunteers will take the drug in different forms so researchers can understand how it is absorbed and how it moves through the body—important early-stage information before testing the drug in patients. **You may be eligible if...** - You are a healthy adult between 18 and 55 years old - Your body mass index (BMI) is between 23 and 35 kg/m² - You weigh at least 60 kg - You have no significant medical history or active illnesses - You are not pregnant, breastfeeding, or planning to become pregnant (if applicable), and agree to use effective contraception **You may NOT be eligible if...** - You have any significant health condition or recent surgery/trauma - You test positive for hepatitis B or C - You test positive for drugs of abuse, alcohol, or nicotine at screening - You have abnormal lab results or vital signs - You have special dietary needs you cannot change Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAZD5004

AZD5004 will be administered orally.


Locations(2)

Research Site

Glendale, California, United States

Research Site

Baltimore, Maryland, United States

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NCT07455825


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