A Study to Investigate Multiple Ascending Doses and Relative Bioavailability of AZD5004 in Healthy Participants

NCT06555822 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: D7260C00004
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to assess the safety, tolerability, and pharmacokinetic (PK) of AZD5004 administered as multiple oral doses in healthy participants and to compare the relative bioavailability of two oral tablet strengths of AZD5004.

Conditions

Healthy Participants

Keywords

Obesity; Type 2 Diabetes

Outcome Measures

Primary Outcomes (5)

• Part A: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

  To assess the safety and tolerability of AZD5004 following oral multiple ascending doses in healthy participants.

  From screening (Day -28) to last follow up visit (Day 120)

• Part B: Maximum observed plasma (peak) drug concentration (Cmax) of AZD5004

  To evaluate the Cmax of 2 treatments of AZD5004 in healthy participants.

  From Day 1 (Treatment Period 1) to Day 13 (end of Treatment Period 2)

• Part B: Area under the concentration-curve from time zero to the last quantifiable concentration (AUClast)

  To evaluate the AUClast of 2 treatments of AZD5004 in healthy participants.

  From Day 1 (Treatment Period 1) to Day 13 (end of Treatment Period 2)

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

  To evaluate the AUCinf of 2 treatments of AZD5004 in healthy participants.

  From Day 1 (Treatment Period 1) to Day 13 (end of Treatment Period 2)

• Part B: Time to reach maximum observed concentration (tmax)

  To evaluate the tmax of 2 treatments of AZD5004 in healthy participants.

  From Day 1 (Treatment Period 1) to Day 13 (end of Treatment Period 2)

Secondary Outcomes (11)

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

  From Day 1 to last follow up visit (Day 120)

• Part A: Area under the concentration-curve from time zero to the last quantifiable concentration (AUClast)

  From Day 1 to last follow up visit (Day 120)

• Part A: Area under concentration time curve in the dosing interval (AUCtau)

  From Day 1 to last follow up visit (Day 120)

• Part A: Amount of unchanged drug excreted into urine from time t1 to time t2 (Ae[t1-t2])

  From Day 1 to last follow up visit (Day 120)

• Part A: Percentage of dose excreted unchanged in urine from time t1 to time t2 (fe[t1-t2])

  From Day 1 to last follow up visit (Day 120)

Study Arms (4)

Part A: Multiple Ascending dose (MAD) (AZD5004)

EXPERIMENTAL

Participants will receive repeated dosing of AZD5004 orally.

Drug: AZD5004

Part A: Placebo

PLACEBO COMPARATOR

Participants will receive matching Placebo orally.

Drug: Placebo

Part B: Treatment 1 (AZD5004)

EXPERIMENTAL

Participants in Group 1 will receive Treatment 1 of AZD5004 and then Treatment 2 of AZD5004. Participants in Group 2 will receive Treatment 2 of AZD5004 and then Treatment 1 of AZD5004.

Drug: AZD5004

Part B: Treatment 2 (AZD5004)

EXPERIMENTAL

Participants in Group 1 will receive Treatment 1 of AZD5004 and then Treatment 2 of AZD5004. Participants in Group 2 will receive Treatment 2 of AZD5004 and then Treatment 1 of AZD5004.

Drug: AZD5004

Interventions

AZD5004 DRUG

Participants will receive oral tablets of AZD5004 in Part A and Part B of the study as per arms they are assigned.

Also known as: ECC5004

Part A: Multiple Ascending dose (MAD) (AZD5004); Part B: Treatment 1 (AZD5004); Part B: Treatment 2 (AZD5004)

Placebo DRUG

Placebo will be administered as an oral tablet once daily.

Part A: Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must have suitable veins for cannulation or repeated venipuncture.
• Female(s) of Childbearing Potential must use adequate contraception (oral contraceptives are not permitted).
• Have a BMI ≥ 23 kg/m2 and not exceeding 35 kg/m2 inclusive and weigh at least 60 kg.
• No or off statin treatment for ≥ 4 weeks prior to the study treatment.

You may not qualify if:

• History of any clinically important disease or disorder.
• History of acute pancreatitis, chronic pancreatitis, gallstones, or elevation in serum lipase/pancreatic amylase.
• History or presence of gastrointestinal, hepatic, or renal disease.
• Clinically significant hepatic disease, inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper gastrointestinal tract.
• Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.
• Any clinically important abnormalities in rhythm, blood pressure, heart rate, conduction or morphology of the resting electrocardiogram (ECG).
• Uncontrolled thyroid disease, defined as thyroid-stimulating hormone \> 6.0 mIU/L or \< 0.4 mIU/L at Screening.
• Current smokers or known history of alcohol or drug abuse.
• History of severe allergy/hypersensitivity or excessive intake of caffeine-containing drinks or food.
• Use of any prescribed or nonprescribed medication including antacids or analgesics.
• Participants who are on or are planning to undertake a weight loss program.
• History of psychosis, major depressive disorder, suicide attempt or suicidal ideation within the past year.
• Lactating, breastfeeding, or pregnant females or females who intend to become pregnant.
• Participants who are vegans or have medical dietary restrictions.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Brooklyn, Maryland, 21225, United States

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 15, 2024
• Study Start: August 15, 2024
• Primary Completion: March 6, 2025
• Study Completion: March 6, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• 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 refer 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. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (1)