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

AstraZeneca14 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Participants

Interventions

AZD0780DRUG

AZD0780 will be administered orally.

MetforminDRUG

Metformin will be administered orally.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Research Site

Brooklyn, Maryland, United States

Outcomes

Primary Outcomes

Area under concentration time curve from time 0 to infinity (AUCinf)

To assess the effect of AZD0780 on the PK of metformin.

Time frame: Days 1 to 3 and Days 8 to 10

Area under concentration curve from time 0 to the last quantifiable concentration (AUClast)

To assess the effect of AZD0780 on the PK of metformin.

Time frame: Days 1 to 3 and Days 8 to 10

Maximum observed drug concentration (Cmax)

To assess the effect of AZD0780 on the PK of metformin.

Time frame: Days 1 to 3 and Days 8 to 10

Secondary Outcomes

Number of participants with Adverse Events (AEs)

To examine the safety and tolerability of AZD0780 in combination with metformin.

Time frame: Day 1 until Follow-up visit or early discontinuation (Up to Day 18)

Apparent total body clearance (CL/F)

To assess the effect of AZD0780 on other PK parameters of metformin.

Time frame: Days 1 to 3 and Days 8 to 10

Apparent volume of distribution based on the terminal phase (Vz/F)

To assess the effect of AZD0780 on other PK parameters of metformin.

Time frame: Days 1 to 3 and Days 8 to 10

Terminal elimination half life (t½λz)

To assess the effect of AZD0780 on other PK parameters of metformin.

Time frame: Days 1 to 3 and Days 8 to 10

Time to reach maximum observed concentration (tmax)

Data from ClinicalTrials.gov

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