NCT07216131

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

A Fixed-sequence, Open-label Study to Assess the Effect of AZD0780 on the Pharmacokinetics of Metformin in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	AZD0780	AZD0780 will be administered orally.
DRUG	Metformin	Metformin will be administered orally.

Timeline

• Start date: 2025-11-10
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2025-10-14
• Last updated: 2026-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study