Comparing oral AZD5004 formulations and food effects in healthy adults

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

This tests how different oral forms of AZD5004 are absorbed, tolerated, and affected by food in healthy adults aged 18 to 55.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Locations: 2 sites (Glendale, California and 1 other locations)
• Trial ID: NCT07455825 on ClinicalTrials.gov

What this trial studies

This Phase 1, randomized, single-dose, two-part, three-period, open-label study compares the pharmacokinetics, safety, and tolerability of multiple oral AZD5004 formulations and examines the effect of food on those formulations in healthy adults. Participants are randomized within cohorts to receive a reference formulation in Period 1 and different test formulations in Periods 2 and 3, with inpatient residency during each dosing period to allow serial PK sampling. The protocol includes a screening period up to 28 days, three treatment periods during which participants remain at the clinical unit, and a follow-up visit 3–7 days after discharge. Findings will inform formulation selection and dosing guidance for later-stage development.

Who should consider this trial

Good fit: Healthy adults aged 18–55 with BMI between 23 and 35 kg/m2, weighing at least 60 kg, with suitable veins for repeated venipuncture and who meet pregnancy/contraception requirements are appropriate candidates.

Not a fit: People with active clinically important diseases, those outside the specified age, BMI or weight ranges, pregnant or breastfeeding individuals, and those seeking immediate therapeutic benefit are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could support development of an effective oral GLP-1 receptor agonist option that may be more convenient than injections for people with metabolic disease.

How similar studies have performed: Formulation and food-effect PK studies have guided development of other oral GLP-1 receptor agonists (for example, oral semaglutide), so this approach has precedent.

Eligibility criteria

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.

Where this trial is running

Glendale, California and 1 other locations

• Research Site — Glendale, California, United States (Recruiting)
• Research Site — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Healthy Participants; Glucagon-like peptide-1 receptor agonist; Anti-hyperglycemic; Pharmacokinetics; Oral formulations; Formulation bridging; Weight management; Type 2 Diabetes Mellitus