Actively Recruiting

Phase 1
Age: 18Years - 55Years
All Genders
Healthy Volunteers
NCT07455825

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

Led by AstraZeneca · Updated on 2026-04-23

64

Participants Needed

2

Research Sites

13 weeks

Total Duration

On this page

Sponsors

A

AstraZeneca

Lead Sponsor

P

Parexel

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Suitable veins for cannulation or repeated venipuncture
  • Negative pregnancy test at screening and on admission for all females
  • Female participants of childbearing potential must not be lactating and agree to use effective contraception if sexually active
  • Female participants of non-childbearing potential must be confirmed at screening
  • Sexually active fertile male participants must use contraception and ensure partners use additional contraception throughout the study
  • Body Mass Index (BMI) between 23 and 35 kg/m2 inclusive at screening
  • Weight of at least 60 kg
Not Eligible

You will not qualify if you...

  • History of any clinically important disease or disorder that could risk safety or affect study participation
  • Any clinically significant illness, medical or surgical procedure, or trauma
  • Special dietary requirements preventing following a uniform diet
  • Positive for anti-hepatitis B core antibody or anti-hepatitis C virus antibody
  • Current or planned participation in a weight loss program during the study
  • Abnormal vital signs after 10 minutes of supine rest at screening or admission
  • Positive screen for drugs of abuse, alcohol, or nicotine
  • Laboratory results with clinically important abnormalities or specified deviations

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Research Site

Glendale, California, United States, 91206

Actively Recruiting

2

Research Site

Baltimore, Maryland, United States, 21225

Actively Recruiting

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Research Team

A

AstraZeneca Clinical Study Information Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

4

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