AzTrials
AzTrials

Healthy ParticipantsPhase 1NCT06996886

A Study in Healthy Participants to Investigate Relative Bioavailability of AZD5004 in Three Solid Oral Formulations

A Phase 1 study testing AZD5004 in people with Healthy Participants, run by AstraZeneca at 1 site 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 relative bioavailability of a single dose AZD5004 in healthy participants, among 3 different oral tablet formulations. 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
16 participants
Where
1 siteUnited States
Study dates
22 May 2025to 25 Jul 2025
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:

  • Healthy male and female participants with suitable veins for cannulation or repeated venipuncture.
  • Female participants:
  1. Female(s) of childbearing potential: If heterosexually active must agree to use an approved method of highly effective contraception.
  2. Female(s) not of childbearing potential
  • Male participants:
  1. Condom use is required for the duration of the clinical study.
  2. Additional contraception must be used for the sexual partners of male study participants throughout the clinical study.
  • Have a Body Mass Index (BMI) ≥ 23 kg/m2 and 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, in the opinion of the Investigator, 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
  • History of acute pancreatitis (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy), chronic pancreatitis, gallstones, or elevation in serum lipase/pancreatic amylase.
  • Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract (including bariatric surgery).
  • Any clinically important illness, medical/surgical procedure, or trauma.
  • Any laboratory values with the deviations specified in protocol and clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.
  • Any positive result at Screening for serum Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb) or Human immunodeficiency Virus (HIV).
  • Abnormal vital signs, after 10 minutes supine rest, at Screening and/or admission to the Clinical Unit.
  • Serum triglyceride concentrations above 1000 mg/dL (11 mmol/L).
  • Basal calcitonin level > 50 ng/L or pg/mL at Screening or history/family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN), type 2.
  • Known or suspected history of alcohol or drug abuse or excessive intake of alcohol
  • Positive screen for drugs of abuse, or alcohol or cotinine (nicotine).
  • History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity or history of hypersensitivity to drugs with a similar chemical structure or class to AZD5004.
  • Excessive intake of caffeine-containing drinks or food
  • History of psychosis or bipolar disorder and major depressive disorder.
  • History of suicide attempt or history of suicidal ideation within the past year.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Research Site

    Baltimore, Maryland, 21225

Other trials in United States

About this study

Official title: An Open-Label, Randomized, Four-Treatment, Four-Period, Single-Dose Crossover Study in Healthy Participants to Assess the Relative Bioavailability of AZD5004 in Three Solid Oral Formulations (F1, F3, F4)

The purpose of this study is to assess the relative bioavailability of a single dose AZD5004 in healthy participants, among 3 different oral tablet formulations.

Read the detailed description

This study will be an open-label, randomized, 4-period, 4-treatment, single-dose crossover study in healthy participants.

Participants will receive one single dose of AZD5004 at the beginning of each of the four Treatment Periods, and a total of 4 doses of AZD5004. Three different formulations (F1, F3, and F4) will be used across the Treatment Periods.

The study comprises of total four treatment periods.

  • A Screening Period of maximum 27 days. Four Treatment Periods of 7 days each.
  • Treatment Period 1 (Day -1 to Day 6)
  • Treatment Period 2 (Day 7 to Day 13)
  • Treatment Period 3 (Day 14 to Day 20)
  • Treatment Period 4 (Day 21 to Day 27)
  • A final Follow-up Visit within 7 to 10 days after the last study intervention administration (Day 22 of Treatment Period 4).

The treatments are as follows:

  • Treatment 1: Single dose of AZD5004 in Formulation 1 (F1) -fasted
  • Treatment 2: Single dose of AZD5004 in Formulation 4 (F4) -fasted
  • Treatment 3: Single dose of AZD5004 in F4- fed
  • Treatment 4: Single dose of AZD5004 in Formulation 3 (F3) - fasted

Participants will be randomized equally to one of the following treatment sequences:

  • Treatment Sequence A: F1, F4, F4 (fed), F3
  • Treatment Sequence B: F4, F4 (fed), F3, F1
  • Treatment Sequence C: F4 (fed), F3, F1, F4
  • Treatment Sequence D: F3, F1, F4, F4 (fed)
Being tested
AZD5004
Keywords
Relative bioavailability, GLP-1 receptor agonist, Type 2 Diabetes Mellitus, Obesity, Oral tablet formulations
Medical subject headings
Diabetes Mellitus, Type 2, Obesity

What participants receive

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

  • AZD5004Drug

    Participants will be receiving three different formulations (F1, F3, and F4) as single dose of AZD5004 orally in fasted and fed state.

Study groups in NCT06996886
Study groupRoleWhat they receive
Treatment Sequence AExperimentalParticipants will receive single dose of AZD5004 on Day 1 in F1 (fasted) (Treatment period 1), on Day 8 in F4 (fasted) (Treatment period 2), on Day 15 in F4(fed) (Treatment Period 3) followed by on Day 22 in F3 (fasted) (Treatment Period 4) respectively.
Receives: Drug: AZD5004
Treatment Sequence BExperimentalPartcipants will receive single dose of AZD5004 on Day 1 in F4 (fasted) (Treatment Period 1), on Day 8 in F4 (fed) (Treatment Period 2), on Day 15 in F3 (fasted) (Treatment Period 3) followed by on Day 22 in F1 (fasted) (Treatment Period 4) respectively.
Receives: Drug: AZD5004
Treatment Sequence CExperimentalParticipants will receive single dose of AZD5004 on Day 1 in F4 (fed) (Treatment Period 1), on Day 8 in F3 (fasted) (Treatment Period 2, on Day 15 in F1 (fasted) (Treatment Period 3 followed by on Day 22 in F4 (fasted) (Treatment Period 4) respectively.
Receives: Drug: AZD5004
Treatment Sequence DExperimentalParticipants will receive single dose of AZD5004 on Day 1 in F3 (fasted) (Treatment Period 1), Day 8 in F1 (fasted) (Treatment Period 2), on Day 15 in F4 (fasted) (Treatment Period 3) followed by Day 22 in F4 (fed) (Treatment Period 4) respectively.
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 to infinity (AUCinf)

    To assess the relative bioavailability of AZD5004 in 3 different solid oral formulations (F1, F3, F4)

    Measured: Day 1-6, Day 8-13, Day 15-20 and Day 22-27

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

    To assess the relative bioavailability of AZD5004 in 3 different solid oral formulations (F1, F3, F4)

    Measured: Day 1-6, Day 8-13, Day 15-20 and Day 22-27

  3. Maximum observed drug concentration (Cmax)

    To assess the relative bioavailability of AZD5004 in 3 different solid oral formulations (F1, F3, F4)

    Measured: Day 1-6, Day 8-13, Day 15-20 and Day 22-27

  4. Time to reach maximum observed concentration (tmax)

    To assess the relative bioavailability of AZD5004 in 3 different solid oral formulations (F1, F3, F4)

    Measured: Day 1-6, Day 8-13, Day 15-20 and Day 22-27

  5. Half-life (t½)

    To assess the relative bioavailability of AZD5004 in 3 different solid oral formulations (F1, F3, F4)

    Measured: Day 1-6, Day 8-13, Day 15-20 and Day 22-27

  6. Apparent total body clearance (CL/F)

    To assess the relative bioavailability of AZD5004 in 3 different solid oral formulations (F1, F3, F4)

    Measured: Day 1-6, Day 8-13, Day 15-20 and Day 22-27

Secondary outcomes (7)

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

    To assess the food effect on the relative bioavailability of AZD5004 in one solid oral formulation (F4)

    Measured: Day 1-6, Day 8-13, Day 15-20 and Day 22-27

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

    To assess the food effect on the relative bioavailability of AZD5004 in one solid oral formulation (F4)

    Measured: Day 1-6, Day 8-13, Day 15-20 and Day 22-27

  3. Maximum observed drug concentration (Cmax)

    To assess the food effect on the relative bioavailability of AZD5004 in one solid oral formulation (F4)

    Measured: Day 1-6, Day 8-13, Day 15-20 and Day 22-27

  4. Time to reach maximum observed concentration (tmax)

    To assess the food effect on the relative bioavailability of AZD5004 in one solid oral formulation (F4)

    Measured: Day 1-6, Day 8-13, Day 15-20 and Day 22-27

  5. Half-life (t½)

    To assess the food effect on the relative bioavailability of AZD5004 in one solid oral formulation (F4)

    Measured: Day 1-6, Day 8-13, Day 15-20 and Day 22-27

  6. Apparent total body clearance (CL/F)

    To assess the food effect on the relative bioavailability of AZD5004 in one solid oral formulation (F4)

    Measured: Day 1-6, Day 8-13, Day 15-20 and Day 22-27

  7. Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    To study the safety and tolerability of a single dose AZD5004 in 3 different solid oral formulations (F1, F3, F4), and F4 under fasted and fed conditions in healthy participants

    Measured: Screening (Day -28 to Day -2) up to Follow-up (Day 29 to Day 32)

Timeline

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

  1. First posted30 May 2025
  2. Study start22 May 2025
  3. Primary completion15 Jul 2025
  4. Study completion25 Jul 2025

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
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06996886
Sponsor's protocol ID
D7260C00012
Status last verified
Jul 2025
First submitted
21 May 2025
Last updated
31 Jul 2025
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 1 site 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 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 to infinity (AUCinf) (time frame: Day 1-6, Day 8-13, Day 15-20 and Day 22-27). The study lists 6 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 NCT06996886.

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 31 Jul 2025.

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