Status:
COMPLETED
A Study to Investigate the Effect of AZD0780 on Metformin Pharmacokinetics in Healthy Adult Volunteers Aged 18 to 55 Years
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 determine how the experimental medication AZD0780 impacts the pharmacokinetics (PK) of metformin, a common medication used to treat type 2 diabetes mellitus, when given...
Detailed Description
This is an open-label, 2-period, fixed-sequence study in healthy participants (males and females), performed at a single Clinical Unit. The study will assess the PK of metformin when administered alon...
Eligibility Criteria
Inclusion
- Have a body mass index (BMI) between 18 and 35 kilograms per meter squared (kg/m2) inclusive and weigh at least 50 kilograms (kg) at the Screening Visit.
- Participants agree to follow study specific contraceptive requirements.
- Have suitable veins for cannulation or repeated venipuncture.
Exclusion
- History of any clinically important disease or disorder which may put the participant at risk because of participation in the study or influence the results.
- Any positive result on Screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV).
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
- 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 metformin or AZD0780.
- Treatment with any lipid lowering therapy or AZD0780 within the 3 months prior to the Screening Visit.
- Treatment with drugs for reduction or inhibition of proprotein convertase subtilisin/kexin type 9 (PCSK9) within the last 12 months prior to the Screening Visit (approved or investigational and apart from AZD0780).
- Current or previous administration of inclisiran.
Key Trial Info
Start Date :
November 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2025
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT07216131
Start Date
November 10 2025
End Date
December 30 2025
Last Update
January 9 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Brooklyn, Maryland, United States, 21225