Status:
COMPLETED
A Study in Healthy Participants to Investigate Relative Bioavailability of AZD5004 in Three Solid Oral Formulations
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Parexel
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
Detailed Description
This study will be an open-label, randomized, 4-period, 4-treatment, single-dose crossover study in healthy participants. Participants will receive one single dose of AZD5004 at the beginning of each...
Eligibility Criteria
Inclusion
- Main
- 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.
- Main
Exclusion
- 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.
Key Trial Info
Start Date :
May 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06996886
Start Date
May 22 2025
End Date
July 25 2025
Last Update
July 31 2025
Active Locations (1)
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1
Research Site
Baltimore, Maryland, United States, 21225