NCT07455825

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

March 5, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

March 3, 2026

Last Update Submit

June 9, 2026

Conditions

Healthy Participants

Keywords

Glucagon-like peptide-1 receptor agonistAnti-hyperglycemicPharmacokinetics (PK)Oral formulationsFormulation bridgingWeight managementType 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (10)

  • Time of maximum observed concentration (tmax)

    From Day 1 to Day 22

  • Terminal rate constant (λz)

    From Day 1 to Day 22

  • Terminal elimination half-life (t½λz)

    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)

    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)

    From Day 1 to Day 22

  • +5 more secondary outcomes

Study Arms (4)

Cohort A: Treatment Sequence ABC

EXPERIMENTAL

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

Cohort A: Treatment Sequence ACB

EXPERIMENTAL

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

Cohort B: Treatment Sequence ADE

EXPERIMENTAL

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

Cohort B: Treatment Sequence AED

EXPERIMENTAL

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

Interventions

AZD5004DRUG

AZD5004 will be administered orally.

Cohort A: Treatment Sequence ABCCohort A: Treatment Sequence ACBCohort B: Treatment Sequence ADECohort B: Treatment Sequence AED

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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:
  • 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.
  • of non-childbearing potential must be confirmed at the Screening Visit.
  • Male participants:
  • Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Glendale, California, 91206, United States

Location

Research Site

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 6, 2026

Study Start

March 5, 2026

Primary Completion

June 1, 2026

Study Completion

June 1, 2026

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

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.

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.
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.
More information

Locations

US(2)