Status:
COMPLETED
A Study to Investigate Multiple Ascending Doses and Relative Bioavailability of AZD5004 in Healthy Participants
Lead Sponsor:
AstraZeneca
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 bioava...
Detailed Description
This study comprises of 2 parts - Part A and Part B. Part A is a placebo-controlled study to assess the safety, efficacy, tolerability, and PK of repeated dosing of AZD5004 compared with placebo. Pa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2025
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT06555822
Start Date
August 15 2024
End Date
March 6 2025
Last Update
March 17 2025
Active Locations (1)
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1
Research Site
Brooklyn, Maryland, United States, 21225