NCT06996886

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2025

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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

May 21, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

May 22, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 30, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2025

Completed
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

May 21, 2025

Last Update Submit

July 30, 2025

Conditions

Healthy Participants

Keywords

Relative bioavailabilityGLP-1 receptor agonistType 2 Diabetes MellitusObesityOral tablet formulations

Outcome Measures

Primary Outcomes (6)

  • 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)

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

  • 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)

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

  • Maximum observed drug concentration (Cmax)

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

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

  • Time to reach maximum observed concentration (tmax)

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

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

  • Half-life (t½)

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

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

  • Apparent total body clearance (CL/F)

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

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

Secondary Outcomes (7)

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

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

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

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

  • Maximum observed drug concentration (Cmax)

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

  • Time to reach maximum observed concentration (tmax)

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

  • Half-life (t½)

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

  • +2 more secondary outcomes

Study Arms (4)

Treatment Sequence A

EXPERIMENTAL

Participants 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.

Drug: AZD5004

Treatment Sequence B

EXPERIMENTAL

Partcipants 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.

Drug: AZD5004

Treatment Sequence C

EXPERIMENTAL

Participants 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.

Drug: AZD5004

Treatment Sequence D

EXPERIMENTAL

Participants 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.

Drug: AZD5004

Interventions

AZD5004DRUG

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

Treatment Sequence ATreatment Sequence BTreatment Sequence CTreatment Sequence D

Eligibility Criteria

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

You may qualify if:

  • Healthy male and female participants with suitable veins for cannulation or repeated venipuncture.
  • Female participants:
  • Female(s) of childbearing potential: If heterosexually active must agree to use an approved method of highly effective contraception.
  • Female(s) not of childbearing potential
  • Male participants:
  • Condom use is required for the duration of the clinical study.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

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

May 21, 2025

First Posted

May 30, 2025

Study Start

May 22, 2025

Primary Completion

July 15, 2025

Study Completion

July 25, 2025

Last Updated

July 31, 2025

Record last verified: 2025-07

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(1)