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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: AZD5004

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A: Treatment Sequence ABC; Participants 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.	Drug: AZD5004; AZD5004 will be administered orally.
Experimental: Cohort A: Treatment Sequence ACB; Participants 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.	Drug: AZD5004; AZD5004 will be administered orally.
Experimental: Cohort B: Treatment Sequence ADE; Participants 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).	Drug: AZD5004; AZD5004 will be administered orally.
Experimental: Cohort B: Treatment Sequence AED; Participants 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).	Drug: AZD5004; AZD5004 will be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From Day 1 to Day 22
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	From Day 1 to Day 22
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	From Day 1 to Day 22

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From Day 1 to Day 22
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	From Day 1 to Day 22
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	From Day 1 to Day 22
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	From Day 1 to Day 22
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	From Day 1 to Day 22
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	From Day 1 to Day 22
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	From Day 1 to Day 22
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	From Day 1 to Day 22
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	From Day 1 to Day 22
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	Up to Follow up (3 to 7 days after discharge)

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Parexel

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2026
• Primary Completion (Actual): June 1, 2026
• Study Completion (Actual): June 1, 2026

Study Registration Dates

• First Submitted: March 3, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Type 2 Diabetes Mellitus; Weight management; Pharmacokinetics (PK); Glucagon-like peptide-1 receptor agonist; Oral formulations; Anti-hyperglycemic; Formulation bridging
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: D7260C00008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No