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Completed

NCT Number: NCT07216131

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Brooklyn, Maryland, 21225, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD0780

Drug

AZD0780 will be administered orally.

metformin

Drug

Metformin will be administered orally.

Primary outcomes

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

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

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

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

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

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

  3. Maximum observed drug concentration (Cmax)

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

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

Secondary outcomes

  1. Number of participants with Adverse Events (AEs)

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

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

  2. Apparent total body clearance (CL/F)

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

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

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

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

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

  4. Terminal elimination half life (t½λz)

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

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

  5. Time to reach maximum observed concentration (tmax)

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

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

  6. Renal clearance (CLR)

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

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

  7. Amount of unchanged drug excreted into urine (Ae)

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

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

  8. Percentage of dose excreted unchanged in urine (fe)

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

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Parexel

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 14, 2025
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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