Healthy ParticipantsPhase 1NCT07444424
A Study to Investigate the Effect of AZD5004 on Mitiglinide and Pioglitazone in Healthy Participants
A Phase 1 study testing AZD5004, Mitiglinide and Pioglitazone in people with Healthy Participants, run by AstraZeneca at 1 site in Japan.
Trial summary
The purpose of the study is to assess the effect of AZD5004 on the pharmacokinetics (PK) of mitiglinide and pioglitazone 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?
- AZD5004, Mitiglinide and Pioglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteJapan
- Study dates
- 13 Mar 2026to 2 Jul 2026
- 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
- Participants with suitable veins for cannulation or repeated venipuncture.
- All females must have a negative serum pregnancy test at the Screening Visit and on admission to the study site.
- Females of childbearing potential must agree to use a highly effective contraception method from enrollment.
- Male Participants, if heterosexually active, must practice true abstinence or use condoms during the trial and their female partners of childbearing potential must use additional effective contraception during the trial.
- Body Mass Index (BMI) between 18 and 35 kg/m² and weigh at least 50 kg.
Who cannot join
- History of any clinically important disease or disorder which may put the participant at risk or influence the results, including:
- Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper gastrointestinal (GI) tract
- Cardiovascular disease
- Neuromuscular or neurogenic disease
- Type 1 or type 2 diabetes mellitus
- History of acute pancreatitis, chronic pancreatitis, gallstones, or elevation in serum lipase/pancreatic amylase.
Show all 17Show fewer
- History of clinically significant cardiovascular, dermatological, respiratory, neurological, psychiatric or GI disease disorder.
- History of malignant neoplastic disease.
- History or presence of GI disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically important illness, medical/surgical procedure, or trauma.
- Any clinically important abnormalities in clinical chemistry, hematology, coagulation, or urinalysis results.
- Basal calcitonin level ≥ 35 ng/L or history/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2).
- Uncontrolled thyroid disease.
- Any positive result on screening for serum human immunodeficiency virus (HIV).
- Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs with a similar chemical structure or class to AZD5004, or to mitiglinide and/or pioglitazone.
- Participants who have previously received AZD5004.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Fixed-sequence, Two-part Study to Assess the Effect of AZD5004 on the Pharmacokinetics of Mitiglinide and Pioglitazone in Healthy Participants
The purpose of the study is to assess the effect of AZD5004 on the pharmacokinetics (PK) of mitiglinide and pioglitazone in healthy participants.
Read the detailed description
This is an open-label, fixed-sequence, two-part study of mitiglinide (Part A) and pioglitazone (Part B) in healthy participants. Part A will assess the PK of mitiglinide when administered alone and in combination with AZD5004 while Part B will assess the PK of pioglitazone when administered alone and in combination of AZD5004.
Both parts are independent and non-sequential to each other.
Each study part will comprise of:
- A screening period of maximum 28 days.
- Four sequential treatment periods during which the participants will receive the study interventions.
- A final follow-up visit
- Conditions
- Healthy Participants
- Being tested
- AZD5004, Mitiglinide, Pioglitazone
- Keywords
- Pharmacokinetics, Type 2 Diabetes, Obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5004Drug
AZD5004 will be administered orally.
MitiglinideDrug
Mitiglinide will be administered orally.
PioglitazoneDrug
Pioglitazone will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Mitiglinide + AZD5004 | Experimental | In Period 1, participants receive a single dose of mitiglinide on Day 1, followed by single doses of AZD5004 Dose A once daily from Days 3-9, then single doses of AZD5004 Dose B once daily from Days 10-16. In Period 2, participants receive single dose of mitiglinide co-administered with single dose of AZD5004 Dose B on Day 17, followed by a single dose of AZD5004 Dose B on Day 18, then single doses of AZD5004 Dose C once daily from Days 19-25, followed by single doses of AZD5004 Dose D once daily from Days 26-32. In Period 3, participants receive single dose of mitiglinide co-administered with single dose of AZD5004 Dose D on Day 33, followed by a single dose of AZD5004 Dose D on Day 34, then single doses of AZD5004 Dose E once daily from Days 35-41. In Period 4, participants receive single dose of mitiglinide co-administered with single dose of AZD5004 Dose E on Day 42, followed by a single dose of AZD5004 Dose E on Day 43. Receives: Drug: AZD5004; Drug: Mitiglinide |
| Part B: Pioglitazone + AZD5004 | Experimental | In Period 1, participants receive a single dose of pioglitazone on Day 1, followed by single doses of AZD5004 Dose A once daily from Days 8-14, then single doses of AZD5004 Dose B once daily from Days 15-21. In Period 2, participants receive single dose of pioglitazone co-administered with single dose of AZD5004 Dose B on Day 22, followed by single doses of AZD5004 Dose B once daily from Days 23-28, then single doses of AZD5004 Dose C once daily from Days 29-35, followed by single doses of AZD5004 Dose D once daily from Days 36-42. In Period 3, participants receive single dose of pioglitazone co-administered with single dose of AZD5004 Dose D on Day 43, followed by single doses of AZD5004 Dose D once daily from Days 44-49, then single doses of AZD5004 Dose E once daily from Days 50-56. In Period 4, participants receive single dose of pioglitazone co-administered with single dose of AZD5004 Dose E on Day 57, followed by single doses of AZD5004 Dose E once daily from Days 58-63. Receives: Drug: AZD5004; Drug: Pioglitazone |
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 AZD5004 on the PK (AUCinf) of mitiglinide and pioglitazone in healthy participants
Measured: Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
To assess the effect of AZD5004 on the PK (AUClast) of mitiglinide and pioglitazone in healthy participants
Measured: Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70
Maximum observed drug concentration (Cmax)
To assess the effect of AZD5004 on the PK (Cmax) of mitiglinide and pioglitazone in healthy participants
Measured: Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70
Secondary outcomes (10)
Number of participants with adverse events (AEs) and AE of special interest (AESI)
To examine the safety and tolerability of AZD5004 alone and in combination with mitiglinide and pioglitazone in healthy participants
Measured: Part A: Up to follow-up visit [Day 54 (± 3 days)]; Part B: Up to follow-up visit [Day 74 (± 3 days)]
Terminal elimination half-life (t½λz)
To assess the effect of AZD5004 on the PK (t½λz) of mitiglinide and pioglitazone in healthy participants
Measured: Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70
Terminal rate constant (λz)
To assess the effect of AZD5004 on the PK (λz) of mitiglinide and pioglitazone in healthy participants
Measured: Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70
Time to reach maximum observed concentration (tmax)
To assess the effect of AZD5004 on the PK (tmax) of mitiglinide and pioglitazone in healthy participants
Measured: Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70
Part A: Ratio of mitiglinide + AZD5004 to mitiglinide (alone) based on AUCinf (RAUCinf)
To assess the effect of AZD5004 on the PK (RAUCinf) of mitiglinide in healthy participants
Measured: From Day 1 to Day 50
Part A: Ratio of mitiglinide + AZD5004 to mitiglinide (alone) based on AUClast (RAUClast)
To assess the effect of AZD5004 on the PK (RAUClast) of mitiglinide in healthy participants
Measured: From Day 1 to Day 50
Part A: Ratio of mitiglinide + AZD5004 to mitiglinide (alone) based on Cmax (RCmax)
To assess the effect of AZD5004 on the PK (RCmax) of mitiglinide in healthy participants
Measured: From Day 1 to Day 50
Part B: Ratio of pioglitazone + AZD5004 to pioglitazone (alone) based on AUCinf (RAUCinf)
To assess the effect of AZD5004 on the PK (RAUCinf) of pioglitazone in healthy participants
Measured: From Day 1 to Day 70
Part B: Ratio of pioglitazone + AZD5004 to pioglitazone (alone) based on AUClast (RAUClast)
To assess the effect of AZD5004 on the PK (RAUClast) of pioglitazone in healthy participants
Measured: From Day 1 to Day 70
Part B: Ratio of pioglitazone + AZD5004 to pioglitazone (alone) based on Cmax (RCmax)
To assess the effect of AZD5004 on the PK (RCmax) of pioglitazone in healthy participants
Measured: From Day 1 to Day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start13 Mar 2026
- Primary completion2 Jul 2026
- Study completion2 Jul 2026
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT07444424
- Sponsor's protocol ID
- D7260C00024
- Status last verified
- Jul 2026
- First submitted
- 26 Feb 2026
- Last updated
- 13 Jul 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 are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Fixed-sequence, Two-part Study to Assess the Effect of AZD5004 on the Pharmacokinetics of Mitiglinide and Pioglitazone in Healthy Participants
- ClinicalTrials.gov ID
- NCT07444424
- Acronym / sponsor ID
- D7260C00024
- Conditions
- Healthy Participants
- Keywords
- Pharmacokinetics, Type 2 Diabetes, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- 2 Jul 2026 (actual)
- Study completion
- 2 Jul 2026 (actual)
- First posted
- 2 Mar 2026 (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 the study is to assess the effect of AZD5004 on the pharmacokinetics (PK) of mitiglinide and pioglitazone in healthy participants.
Detailed description
This is an open-label, fixed-sequence, two-part study of mitiglinide (Part A) and pioglitazone (Part B) in healthy participants. Part A will assess the PK of mitiglinide when administered alone and in combination with AZD5004 while Part B will assess the PK of pioglitazone when administered alone and in combination of AZD5004.
Both parts are independent and non-sequential to each other.
Each study part will comprise of:
- A screening period of maximum 28 days.
- Four sequential treatment periods during which the participants will receive the study interventions.
- A final follow-up visit
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: Mitiglinide + AZD5004 | Experimental | Drug: AZD5004, Drug: MitiglinideIn Period 1, participants receive a single dose of mitiglinide on Day 1, followed by single doses of AZD5004 Dose A once daily from Days 3-9, then single doses of AZD5004 Dose B once daily from Days 10-16. In Period 2, participants receive single dose of mitiglinide co-administered with single dose of AZD5004 Dose B on Day 17, followed by a single dose of AZD5004 Dose B on Day 18, then single doses of AZD5004 Dose C once daily from Days 19-25, followed by single doses of AZD5004 Dose D once daily from Days 26-32. In Period 3, participants receive single dose of mitiglinide co-administered with single dose of AZD5004 Dose D on Day 33, followed by a single dose of AZD5004 Dose D on Day 34, then single doses of AZD5004 Dose E once daily from Days 35-41. In Period 4, participants receive single dose of mitiglinide co-administered with single dose of AZD5004 Dose E on Day 42, followed by a single dose of AZD5004 Dose E on Day 43. |
| Part B: Pioglitazone + AZD5004 | Experimental | Drug: AZD5004, Drug: PioglitazoneIn Period 1, participants receive a single dose of pioglitazone on Day 1, followed by single doses of AZD5004 Dose A once daily from Days 8-14, then single doses of AZD5004 Dose B once daily from Days 15-21. In Period 2, participants receive single dose of pioglitazone co-administered with single dose of AZD5004 Dose B on Day 22, followed by single doses of AZD5004 Dose B once daily from Days 23-28, then single doses of AZD5004 Dose C once daily from Days 29-35, followed by single doses of AZD5004 Dose D once daily from Days 36-42. In Period 3, participants receive single dose of pioglitazone co-administered with single dose of AZD5004 Dose D on Day 43, followed by single doses of AZD5004 Dose D once daily from Days 44-49, then single doses of AZD5004 Dose E once daily from Days 50-56. In Period 4, participants receive single dose of pioglitazone co-administered with single dose of AZD5004 Dose E on Day 57, followed by single doses of AZD5004 Dose E once daily from Days 58-63. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants with suitable veins for cannulation or repeated venipuncture.
- All females must have a negative serum pregnancy test at the Screening Visit and on admission to the study site.
- Females of childbearing potential must agree to use a highly effective contraception method from enrollment.
- Male Participants, if heterosexually active, must practice true abstinence or use condoms during the trial and their female partners of childbearing potential must use additional effective contraception during the trial.
- Body Mass Index (BMI) between 18 and 35 kg/m² and weigh at least 50 kg.
Key exclusion criteria (17 listed)
- History of any clinically important disease or disorder which may put the participant at risk or influence the results, including:
- History of acute pancreatitis, chronic pancreatitis, gallstones, or elevation in serum lipase/pancreatic amylase.
- History of clinically significant cardiovascular, dermatological, respiratory, neurological, psychiatric or GI disease disorder.
- History of malignant neoplastic disease.
- History or presence of GI disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
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 |
|---|---|---|
| AZD5004AZD5004 will be administered orally. | Drug | Part A: Mitiglinide + AZD5004, Part B: Pioglitazone + AZD5004 |
| MitiglinideMitiglinide will be administered orally. | Drug | Part A: Mitiglinide + AZD5004 |
| PioglitazonePioglitazone will be administered orally. | Drug | Part B: Pioglitazone + AZD5004 |
Primary outcome
Area under concentration-time curve from time 0 to infinity (AUCinf)
Time frame: Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70
To assess the effect of AZD5004 on the PK (AUCinf) of mitiglinide and pioglitazone in healthy participants
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70
To assess the effect of AZD5004 on the PK (AUClast) of mitiglinide and pioglitazone in healthy participants
Maximum observed drug concentration (Cmax)
Time frame: Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70
To assess the effect of AZD5004 on the PK (Cmax) of mitiglinide and pioglitazone in healthy participants
10 secondary outcomes
Number of participants with adverse events (AEs) and AE of special interest (AESI)
Time frame: Part A: Up to follow-up visit [Day 54 (± 3 days)]; Part B: Up to follow-up visit [Day 74 (± 3 days)]
Terminal elimination half-life (t½λz)
Time frame: Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70
Terminal rate constant (λz)
Time frame: Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70
Time to reach maximum observed concentration (tmax)
Time frame: Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70
Part A: Ratio of mitiglinide + AZD5004 to mitiglinide (alone) based on AUCinf (RAUCinf)
Time frame: From Day 1 to Day 50
Part A: Ratio of mitiglinide + AZD5004 to mitiglinide (alone) based on AUClast (RAUClast)
Time frame: From Day 1 to Day 50
Part A: Ratio of mitiglinide + AZD5004 to mitiglinide (alone) based on Cmax (RCmax)
Time frame: From Day 1 to Day 50
Part B: Ratio of pioglitazone + AZD5004 to pioglitazone (alone) based on AUCinf (RAUCinf)
Time frame: From Day 1 to Day 70
Part B: Ratio of pioglitazone + AZD5004 to pioglitazone (alone) based on AUClast (RAUClast)
Time frame: From Day 1 to Day 70
Part B: Ratio of pioglitazone + AZD5004 to pioglitazone (alone) based on Cmax (RCmax)
Time frame: From Day 1 to Day 70
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 13 Jul 2026.
- 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 are accepting requests for IPD, but this does not mean all requests will be shared.
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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 AZD5004, Mitiglinide and Pioglitazone in people with Healthy Participants, run by AstraZeneca at 1 site in Japan.
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 5 inclusion and 17 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 13 Jul 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 Japan. 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: Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70). 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 13 Jul 2026.