A Study to Investigate the Effect of AZD0780 on Metformin Pharmacokinetics in Healthy Adult Volunteers Aged 18 to 55 Years

Purpose

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 together in healthy participants.

Condition

  • Healthy Participants

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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 Criteria

  • 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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Metformin/Metformin + AZD0780 		Participants will receive a single dose of metformin on Day 1 in Treatment Period 1 followed by a washout period of 7 days. In Treatment Period 2, participants will receive a single dose of AZD0780 followed by a single dose of metformin on Day 8.
  • Drug: AZD0780
    AZD0780 will be administered orally.
  • Drug: Metformin
    Metformin will be administered orally.

Recruiting Locations

Research Site
Brooklyn 4349594, Maryland 4361885 21225

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

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 alone and in combination with a single dose of AZD0780. The study will comprise: - A Screening Period of maximum 28 days. - Two Treatment Periods (Day -1 to Day 7 and Day 8 to Day 10) during which participants will be resident at the Clinical Unit and will receive the study intervention. - A final Follow-up Visit.