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

NCT07216131 | Completed Phase 1 FDA Drug

• 1 other identifier: D7960C00003
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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 together in healthy participants.

Conditions

Healthy Participants

Keywords

Renal Transporter; Multidrug and Toxic Compound Extrusion 1; Dyslipidemia; Proprotein Convertase Subtilisin/Kexin Type 9

Outcome Measures

Primary Outcomes (3)

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

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

  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.

  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.

  Days 1 to 3 and Days 8 to 10

Secondary Outcomes (8)

• Number of participants with Adverse Events (AEs)

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

• Apparent total body clearance (CL/F)

  Days 1 to 3 and Days 8 to 10

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

  Days 1 to 3 and Days 8 to 10

• Terminal elimination half life (t½λz)

  Days 1 to 3 and Days 8 to 10

• Time to reach maximum observed concentration (tmax)

  Days 1 to 3 and Days 8 to 10

Study Arms (1)

Metformin/Metformin + AZD0780

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.

Drug: AZD0780; Drug: Metformin

Interventions

AZD0780 DRUG

AZD0780 will be administered orally.

Metformin/Metformin + AZD0780

Metformin DRUG

Metformin will be administered orally.

Metformin/Metformin + AZD0780

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (1)

Research Site

Brooklyn, Maryland, 21225, United States

Location

Related Links

• Thank You Card

MeSH Terms

Conditions

Dyslipidemias; Hypercholesterolemia, Autosomal Dominant, 3

Interventions

Metformin

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2025
• First Posted: October 14, 2025
• Study Start: November 10, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (1)