GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Study to Investigate the Impact of Multiple Doses of Itraconazole on AZD5004 in Healthy Participants and Multiple Doses of AZD5004 on Combined Oral Ethinyl Oestradiol and Levonorgestrel in Healthy Female Participants

An Open-label, Fixed-sequence and Two-part Study to Assess the Impact of Multiple Doses of Itraconazole on the Pharmacokinetics of AZD5004 in Healthy Participants and Multiple Doses of AZD5004 on the Pharmacokinetics of Combined Oral Ethinyl Oestradiol and Levonorgestrel in Healthy Female Participants

Lead sponsor

AstraZeneca

Asset

AZD5004 / ECC5004

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criterion

•BMI 18.5-35

Primary endpoints

•Part•Part B

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06942936

Org study IDD7260C00007

Secondary ID2024-518467-35-00EUCT number

Timeline

Milestones

Study first posted2025-04-24actual

Study start2025-05-28actual

Primary completion2026-01-28actual

Study completion2026-01-28actual

Last update posted2026-02-03actual

Assets

Investigational agents

AZD5004 / ECC5004

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersAccepted

Eligibility criteria

Main Inclusion Criteria:

Part A -

•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.

•Females of childbearing potential must not be lactating, must agree to use approved method of contraceptive.

•Sexually active fertile male participants with female partners of childbearing potential must adhere to the approved contraception methods.

•Have a Body Mass Index (BMI) between ≥ 18.5 kg/m2 and ≤ 35 kg/m2 (at the time of screening) and weigh at least 50 kg.

Part B -

•Females of non-childbearing potential must be confirmed at the Screening Visit by fulfilling one of the following criteria:

1. Postmenopausal defined as amenorrhoea for at least 12 months following cessation of all exogenous hormonal treatments and Follicle-stimulating hormone (FSH) levels (> 40 mIU/mL).

2. Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion.

•Have a BMI between ≥ 23 kg/m2 and ≤ 30 kg/m2 and weigh at least 55 kg.

Main Exclusion Criteria:

Part A and Part B-

•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.

•History of acute pancreatitis (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy), chronic pancreatitis, gallstones, or elevation in serum lipase/pancreatic amylase at screening.

•History or presence of any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.

•Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.

•Abnormal laboratory values, hepatic disease, Human Immunodeficiency Virus (HIV) positive, abnormal vital signs, abnormalities in rhythm, uncontrolled thyroid disease.

•Known smoker, history of alcohol, drug abuse or caffeine intake.

•Use of prescribed or unsubscribed medication within 3 months prior to screening.

•History of psychosis, bipolar disorder, major depressive disorder.

•Vulnerable participants, e.g., kept in detention, protected adults under guardianship.

Endpoints (19)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

19 endpoints

Primary/protocol endpoint

Part A: Area under concentration-time curve from time zero to infinity (AUCinf) of AZD5004

Time frame:Day 1 and Day 10

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint/low confidence

Part A: Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of AZD5004

Time frame:Day 1 and Day 10

concentration, descriptive

Primary/protocol endpoint

Part A: Maximum observed drug concentration (Cmax) of AZD5004

Time frame:Day 1 and Day 10

Cmax

concentration, descriptive

Primary/protocol endpoint

Part A: Terminal elimination half-life (t1/2λz) of AZD5004

Time frame:Day 1 and Day 10

Half-life

descriptive

Primary/protocol endpoint

Part A: Time to reach maximum observed concentration (tmax) of AZD5004

Time frame:Day 1 and Day 10

Tmax

descriptive

Primary/protocol endpoint

Part A: Apparent total body clearance (CL/F) of AZD5004

Time frame:Day 1 and Day 10

descriptive

Primary/protocol endpoint

Part A: Apparent volume of distribution based on the terminal phase (Vz) of AZD5004

Time frame:Day 1 and Day 10

descriptive

Primary/protocol endpoint

Part B: Area under concentration-time curve from time zero to infinity (AUCinf) of EE/LNG