Recruiting soon

Effect of AZD0780 on Metformin Pharmacokinetics in Healthy Volunteers

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study AimThis study aims to evaluate how the drug AZD0780 affects the body's processing of metformin in healthy volunteers.
What is being tested

AZD0780

+ Metformin
Drug
Who is being recruted

Healthy Participants

From 18 to 55 Years
+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: November 2025

See protocol details

Summary

Principal SponsorAstraZeneca
Study ContactAstraZeneca Clinical Study Information Center
Last updated: October 14, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: November 10, 2025Actual date on which the first participant was enrolled.

This clinical trial aims to study how the drug AZD0780 affects the way the body processes another medication called metformin, which is commonly used to manage blood sugar levels. The study involves healthy male and female participants to understand potential interactions between these two drugs. This research is important because it can provide valuable information about whether AZD0780 changes how metformin works, which could influence future treatments involving these medications. Participants in this study will go through a screening process lasting up to 28 days to ensure they are suitable for the trial. Then, they will spend time living at the clinical unit during two treatment periods, where they will first receive metformin alone and then in combination with AZD0780. The study will observe how the body absorbs, distributes, and eliminates metformin in both scenarios. This trial will help determine if there are any significant changes in the drug's behavior when taken with AZD0780, without specifically mentioning risks or benefits.

Official TitleA Fixed-sequence, Open-label Study to Assess the Effect of AZD0780 on the Pharmacokinetics of Metformin in Healthy Volunteers 
Principal SponsorAstraZeneca
Study ContactAstraZeneca Clinical Study Information Center
Last updated: October 14, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
14 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive treatments one after another in a pre-planned sequence. The next treatment may depend on how the participant responds to the previous one.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 55 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Healthy Participants
Criteria
3 inclusion criteria required to participate
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
7 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
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.
Study Objectives
Primary Objectives

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

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

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

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

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

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

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

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

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

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

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 
Recruiting soonNo study centers