Healthy ParticipantsPhase 1NCT07216131
A Study to Investigate the Effect of AZD0780 on Metformin Pharmacokinetics in Healthy Adult Volunteers Aged 18 to 55 Years
A Phase 1 study testing AZD0780 and Metformin in people with Healthy Participants, run by AstraZeneca at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- AZD0780 and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2025to 30 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Fixed-sequence, Open-label Study to Assess the Effect of AZD0780 on the Pharmacokinetics of Metformin in Healthy Volunteers
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.
Read the 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
- Being tested
- AZD0780, Metformin
- Keywords
- Renal Transporter, Multidrug and Toxic Compound Extrusion 1, Dyslipidemia, Proprotein Convertase Subtilisin/Kexin Type 9
- Medical subject headings
- Dyslipidemias, Hypercholesterolemia, Autosomal Dominant, 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD0780Drug
AZD0780 will be administered orally.
MetforminDrug
Metformin will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: AZD0780; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under concentration time curve from time 0 to infinity (AUCinf)
To assess the effect of AZD0780 on the PK of metformin.
Measured: 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.
Measured: 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.
Measured: Days 1 to 3 and Days 8 to 10
Secondary outcomes (8)
Number of participants with Adverse Events (AEs)
To examine the safety and tolerability of AZD0780 in combination with metformin.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Days 1 to 3 and Days 8 to 10
Time to reach maximum observed concentration (tmax)
To assess the effect of AZD0780 on other PK parameters of metformin.
Measured: Days 1 to 3 and Days 8 to 10
Renal clearance (CLR)
To assess the effect of AZD0780 on other PK parameters of metformin.
Measured: Days 1 to 3 and Days 8 to 10
Amount of unchanged drug excreted into urine (Ae)
To assess the effect of AZD0780 on other PK parameters of metformin.
Measured: Days 1 to 3 and Days 8 to 10
Percentage of dose excreted unchanged in urine (fe)
To assess the effect of AZD0780 on other PK parameters of metformin.
Measured: Days 1 to 3 and Days 8 to 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start10 Nov 2025
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216131
- Sponsor's protocol ID
- D7960C00003
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. ''Yes", indicates that AZ is accepting requests for IPD, but this does not mean all requests will be approved.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Fixed-sequence, Open-label Study to Assess the Effect of AZD0780 on the Pharmacokinetics of Metformin in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07216131
- Acronym / sponsor ID
- D7960C00003
- Conditions
- Healthy Participants
- Keywords
- Renal Transporter, Multidrug and Toxic Compound Extrusion 1, Dyslipidemia, Proprotein Convertase Subtilisin/Kexin Type 9
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 14 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metformin/Metformin + AZD0780 | Experimental | Drug: AZD0780, Drug: MetforminParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD0780AZD0780 will be administered orally. | Drug | Metformin/Metformin + AZD0780 |
| MetforminMetformin will be administered orally. | Drug | Metformin/Metformin + AZD0780 |
Primary outcome
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.
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.
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.
8 secondary outcomes
Number of participants with Adverse Events (AEs)
Time frame: Day 1 until Follow-up visit or early discontinuation (Up to Day 18)
Apparent total body clearance (CL/F)
Time frame: Days 1 to 3 and Days 8 to 10
Apparent volume of distribution based on the terminal phase (Vz/F)
Time frame: Days 1 to 3 and Days 8 to 10
Terminal elimination half life (t½λz)
Time frame: Days 1 to 3 and Days 8 to 10
Time to reach maximum observed concentration (tmax)
Time frame: Days 1 to 3 and Days 8 to 10
Renal clearance (CLR)
Time frame: Days 1 to 3 and Days 8 to 10
Amount of unchanged drug excreted into urine (Ae)
Time frame: Days 1 to 3 and Days 8 to 10
Percentage of dose excreted unchanged in urine (fe)
Time frame: Days 1 to 3 and Days 8 to 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Thank You CardLink provided by the sponsor.
- D7960C00003\_Redacted\_CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. ''Yes", indicates that AZ is accepting requests for IPD, but this does not mean all requests will be approved.
Related trials for Healthy Participants
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD0780 and Metformin in people with Healthy Participants, run by AstraZeneca at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under concentration time curve from time 0 to infinity (AUCinf) (time frame: Days 1 to 3 and Days 8 to 10). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.