NCT06555822CompletedPhase 1
A Study to Investigate Multiple Ascending Doses and Relative Bioavailability of AZD5004 in Healthy Participants
A Phase I, Two-Part Study in Healthy Volunteers Consisting of a Randomized, Single-blind, Placebo-controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD5004 and a Randomized, Open-Label, Two-way Cross-over Study to Compare the Relative Bioavailability of Two Oral Tablet Strengths of AZD5004
Source: ClinicalTrials.gov · Last updated 17 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 13 Aug 2024
- Start date
- 15 Aug 2024
- Primary completion date
- 6 Mar 2025
- Lead sponsor
- AstraZeneca
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT06555822
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 31
- From 15 Aug 2024 to the primary completion date, 6 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of any prescribed or nonprescribed medication including antacids or analgesics.
Other illness
- History of any clinically important disease or disorder.
- 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 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.
- History of psychosis, major depressive disorder, suicide attempt or suicidal ideation within the past year.
Lab values
- History of acute pancreatitis, chronic pancreatitis, gallstones, or elevation in serum lipase/pancreatic amylase.
Other
- Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.
- Participants who are on or are planning to undertake a weight loss program.
- Lactating, breastfeeding, or pregnant females or females who intend to become pregnant.
- Participants who are vegans or have medical dietary restrictions.
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.