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AzTrials

Healthy ParticipantsPhase 1NCT07455825

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

A Phase 1 study testing AZD5004 in people with Healthy Participants, run by AstraZeneca at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
AZD5004
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
2 sitesUnited States
Study dates
5 Mar 2026to 1 Jun 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Main Inclusion Criteria:

  • Participants suitable veins for cannulation or repeated venipuncture.
  • All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
  • Female participants:
  1. of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception, to avoid pregnancy.
  2. of non-childbearing potential must be confirmed at the Screening Visit.
  • Male participants:
  1. Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
  2. Additional contraception must be used for the sexual partners of male study participants throughout the clinical study.
  • Have a Body Mass Index (BMI) of ≥ 23 kg/m2 but not exceeding 35 kg/m2 inclusive (at the time of Screening) and weigh at least 60 kg.

Main Exclusion Criteria:

  • History of any clinically important disease or disorder which, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
  • Any clinically significant illness, medical/surgical procedure, or trauma
  • Participants who have a special dietary requirement and who are unable/unwilling to follow a uniform diet.
  • Participants positive for anti- hepatitis B core antibody (anti-HBc) or anti-hepatitis C Virus Antibody (anti-HCV).
  • Participants who are on or are planning to undertake a weight loss program during the study period.
  • Abnormal vital signs, after 10 minutes supine rest, at Screening and/or admission to the Clinical Unit.
  • Positive screen for drugs of abuse, or alcohol or cotinine (nicotine).
  • Any laboratory values with the deviations specified in protocol and clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Research Site

    Baltimore, Maryland, 21225

  • Research Site

    Glendale, California, 91206

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

This is a Phase I, randomized, single-dose, 2 part, 3-period, open-label study.

There will be 2 Parts (Part A and Part B). In each part, participants will be randomized to a treatment sequence in each cohort. In Period 1, participants in Part A and Part B will receive Regimen A (AZD5004 Formulation 1 [reference]). In Periods 2 and 3, participants in Part A will receive Regimen B or Regimen C (AZD5004 Formulation 5) and participants in Part B will receive Regimen D or Regimen E per assigned treatment sequence.

The study will comprise:

  • A Screening Period of maximum 28 days
  • 3 Treatment Periods during which participants will be resident at the Clinical Unit
  • A final Follow-up Visit within 3 to 7 days after being discharged.
Being tested
AZD5004
Keywords
Glucagon-like peptide-1 receptor agonist, Anti-hyperglycemic, Pharmacokinetics (PK), Oral formulations, Formulation bridging, Weight management, Type 2 Diabetes Mellitus
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD5004Drug

    AZD5004 will be administered orally.

Study groups in NCT07455825
Study groupRoleWhat they receive
Cohort A: Treatment Sequence ABCExperimentalParticipants will receive three treatments in sequence: Regimen A (formulation 1, fasted state), Regimen B (formulation 5, fasted state), followed by Regimen C (formulation 5, fed state) of AZD5004.
Receives: Drug: AZD5004
Cohort A: Treatment Sequence ACBExperimentalParticipants will receive three treatments in sequence: Regimen A (formulation 1, fasted state), Regimen C (formulation 5, fed state), followed by Regimen B (formulation 5, fasted state) of AZD5004.
Receives: Drug: AZD5004
Cohort B: Treatment Sequence ADEExperimentalParticipants will receive three treatments in sequence: Regimen A (formulation 1, fasted state), Regimen D (formulation 6, fasted state), followed by Regimen E (formulation 6, fed state).
Receives: Drug: AZD5004
Cohort B: Treatment Sequence AEDExperimentalParticipants will receive three treatments in sequence: Regimen A (formulation 1, fasted state), Regimen E (formulation 6, fed state), followed by Regimen D (formulation 6, fasted state).
Receives: Drug: AZD5004

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under concentration-time curve from time 0 extrapolated to infinity (AUCinf)

    To evaluate the PK (AUCinf) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants

    Measured: From Day 1 to Day 22

  2. Area under concentration-curve from time 0 to the time of last quantifiable concentration (AUClast)

    To evaluate the PK (AUClast) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants

    Measured: From Day 1 to Day 22

  3. Maximum observed concentration (Cmax)

    To evaluate the PK (Cmax) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants

    Measured: From Day 1 to Day 22

Secondary outcomes (10)

  1. Time of maximum observed concentration (tmax)

    To evaluate the PK (tmax) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants

    Measured: From Day 1 to Day 22

  2. Terminal rate constant (λz)

    To evaluate the PK (λz) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants

    Measured: From Day 1 to Day 22

  3. Terminal elimination half-life (t½λz)

    To evaluate the PK (t½λz) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants

    Measured: From Day 1 to Day 22

  4. Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F)

    To evaluate the PK (CL/F) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants

    Measured: From Day 1 to Day 22

  5. Apparent volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single extravascular administration where F (fraction of dose bioavailable) is unknown (Vz/F)

    To evaluate the PK (Vz/F) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants

    Measured: From Day 1 to Day 22

  6. Time of last measurable observed concentration (tlast)

    To evaluate the PK (tlast) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants

    Measured: From Day 1 to Day 22

  7. R AUC (Ratio of test treatment to reference based on AUC)

    To evaluate the PK (R AUC) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants

    Measured: From Day 1 to Day 22

  8. R Cmax (Ratio of test treatment to reference based on Cmax)

    To evaluate the PK (R Cmax) and assess the effect of food on the PK of different formulations of AZD5004 following single oral administration in healthy participants

    Measured: From Day 1 to Day 22

  9. F AUClast (Relative bioavailability based on AUClast)

    To evaluate the PK (F AUClast) of different formulations of AZD5004 following single oral administration in healthy participants

    Measured: From Day 1 to Day 22

  10. Number of participants with adverse events (AEs), serious AEs and AESIs (adverse events of special interest)

    To assess the safety and tolerability of different formulations of AZD5004 following single oral administration in healthy participants

    Measured: Up to Follow up (3 to 7 days after discharge)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2026
  2. Study start5 Mar 2026
  3. Primary completion1 Jun 2026
  4. Study completion1 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07455825
Sponsor's protocol ID
D7260C00008
Status last verified
Jun 2026
First submitted
3 Mar 2026
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AZD5004 in people with Healthy Participants, run by AstraZeneca at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under concentration-time curve from time 0 extrapolated to infinity (AUCinf) (time frame: From Day 1 to Day 22). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07455825.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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