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AzTrials

Healthy ParticipantsPhase 1NCT06948747

A Study to Investigate the Effect of AZD5004 on Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and the Effect of Erythromycin on AZD5004 in Healthy Participants

A Phase 1 study testing AZD5004, Rosuvastatin and Erythromycin in people with Healthy Participants, run by AstraZeneca at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will assess the effect of AZD5004 on Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and the effect of Erythromycin on AZD5004 in healthy adult male and female 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, Rosuvastatin and Erythromycin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteUnited States
Study dates
6 May 2025to 3 Oct 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

  • Healthy male and female participants aged 18 to 55 years
  • All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
  • Female(s) of childbearing potential if heterosexually active, must agree to use an approved method of highly effective contraception.
  • Male participants must use condoms for the duration of clinical trial.
  • Additional contraception must be used for the sexual partners of male trial participants throughout the clinical trial.
  • Have a body mass index (BMI) between ≥ 20.0 and ≤ 35 kg/m2 (at the time of screening) inclusive and weigh at least 50 kg.

Who cannot join

  • History of any clinically important disease or disorder (liver transplant, liver disease, positive for serum HBsAg (Hepatitis B surface antigen) OR anti-HBcAb (Hepatitis B core antibody), positive for anti-HCV (Hepatitis C virus), history of cirrhosis and/or hepatic decompensation, cardiovascular disease, neuromuscular or neurogenic disease.
  • History of Type 1 or Type 2 diabetes mellitus (DM).
  • History of Hemoglobin A1c ≥ 6.5% (≥ 48 mmol/mol) at screening.
  • History or presence of gastrointestinal, hepatic, or renal 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 laboratory values with deviations or clinically important abnormalities in clinical chemistry, hematology, or urinalysis at the Screening Visit or on admission to the Clinical Unit.
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  • Significant hepatic disease as judged by the investigator.
  • Any positive result on screening for serum HBsAg, HBcAb or HIV (Human immunodeficiency virus).
  • Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12 lead ECG, at screening
  • Abnormal vital signs.
  • Uncontrolled thyroid disease or history/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2).
  • Current smokers or those who have smoked or used nicotine products.
  • Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the investigator. Excessive intake of alcohol defined as the regular consumption of more than 24 g of alcohol per day for men or 12 g of alcohol per day for females.
  • Positive screen for drugs of abuse, or alcohol or cotinine at screening or on each admission to the Clinical Unit.
  • History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
  • Excessive intake of caffeine-containing drinks or food
  • History of psychosis or bipolar disorder or major depressive disorder or suicide attempt or suicidal ideation.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Research Site

    Brooklyn, Maryland, 21225

Other trials in United States

About this study

Official title: An Open-label, Fixed-sequence, Three-part Study to Assess the Effect of AZD5004 on the Pharmacokinetics of Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and to Assess the Effect of Erythromycin on AZD5004 in Healthy Participants

This study will assess the effect of AZD5004 on Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and the effect of Erythromycin on AZD5004 in healthy adult male and female participants.

Read the detailed description

This is a Phase I, open-label, fixed-sequence, single center study which consists of 3 parts: Part A, Part B and Part C. Part A, Part B, and Part C are 3 independent and non-sequential parts in this study.

The purpose of Part A (Rosuvastatin and Erythromycin) of this study is to measure the following in healthy male and female participants,

  1. The impact of AZD5004 on the pharmacokinetics (PK: the way the body absorbs, distributes, metabolizes, and eliminates a medicine) of rosuvastatin and
  2. The impact of erythromycin on the PK of AZD5004

The purpose of Part B (Atorvastatin and Simvastatin) of this study is to measure the impact of AZD5004 on the PK of atorvastatin and simvastatin in healthy male and female participants.

The purpose of Part C (Repaglinide) of this study is to measure the impact of AZD5004 on the PK of repaglinide in healthy male and female participants.

Part A will consist of a screening period, 8 treatment periods, and a follow-up period.

Part B will consist of a screening period, 7 treatment periods, and a follow-up period.

Part C will consist of a screening period, 4 treatment periods, and a follow-up period.

Being tested
AZD5004, Rosuvastatin, Erythromycin, Atorvastatin, Simvastatin
Keywords
Obesity, Type 2 Diabetes Mellitus (T2DM), Pharmacokinetics
Medical subject headings
Obesity, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD5004Drug

    Participants will receive oral tablets of AZD5004 as single dose on the following days, (i) Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 and Day 55 in Part A. (ii) Day 9 to Day15, Day 16, Day 17 to Day 23, Day 24 to Day 30, Day 31 to Day 37, Day 38 to Day 41 and Day 42 in Part B.

    (iii) Day 3 to Day 9, Day 10 to Day 25, Day 26 to Day 33, and Day 34 in Part C.

  • RosuvastatinDrug

    Participants will receive single oral tablets of rosuvastatin 10mg on Days 1, 7, 14, 21, 28, and 35.

  • ErythromycinDrug

    Participants will receive oral doses of erythromycin 500 mg, twice a day from Day 49 to Day 54; and a single dose of 500 mg on Day 55.

  • AtorvastatinDrug

    Participants will receive single oral doses of 40 mg atorvastatin on Days 4, 8, 16, 38, and 42.

  • SimvastatinDrug

    Participants will receive single oral doses of 20 mg simvastatin on Days 1 and 31.

  • RepaglinideDrug

    Participants will receive single oral doses of 0.5 mg repaglinide on Days 1, 10, 26, and 34.

Study groups in NCT06948747
Study groupRoleWhat they receive
Part AExperimentalParticipants will receive 10 mg rosuvastatin in Period 1. Participants will receive 10 mg rosuvastatin and AZD5004 in Period 2. Later, participants will receive different doses of AZD5004 followed by 10 mg single dose of rosuvastatin in Period 3, Period 4, Period 5, and Period 6. In Period 7, participants will receive AZD5004 alone and later, 500 mg erythromycin twice a day. Participants will receive 500 mg erythromycin co-administered with AZD5004 during Period 8.
Receives: Drug: AZD5004; Drug: Rosuvastatin; Drug: Erythromycin
Part BExperimentalParticipants will receive 20 mg simvastatin during Period 1. In Period 2, participants will receive 40mg atorvastatin. In Period 3, participants will receive 40 mg atorvastatin and then, AZD5004 once daily . During Period 4, participants will receive 40 mg atorvastatin with single dose of AZD5004 and later, two different doses of AZD5004 alone will be administered once a day. In Period 5, participants will receive 20 mg simvastatin with single dose of AZD5004, later, AZD5004 alone will be administered once a day. During Period 6, participants will receive 40 mg atorvastatin with single dose of AZD5004 initially, and later AZD5004 will be administered once daily. In Period 7, participants will receive AZD5004 followed by 40 mg single dose of atorvastatin.
Receives: Drug: AZD5004; Drug: Atorvastatin; Drug: Simvastatin
Part CExperimentalParticipants will receive 0.5 mg repaglinide initially during Period 1, later AZD5004 once daily will be administered . Participants will then receive 0.5 mg repaglinide with single dose of AZD5004 in Period 2, later two different doses of AZD5004 once daily will be administered. In Period 3, participants will receive 0.5 mg repaglinide with single dose of AZD5004 initially, and later AZD5004 once daily will be administered. In Period 4, participants will receive 0.5 mg repaglinide with single dose of AZD5004.
Receives: Drug: AZD5004; Drug: Repaglinide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A, Part B and Part C: Area under concentration time curve from time 0 to infinity (AUCinf)

    Part A: To assess the effect of single dose of AZD5004 on the PK of a single dose of rosuvastatin and multiple doses of erythromycin on the PK of a single dose of AZD5004 in healthy participants.

    Part B: To assess the effect of multiple doses of AZD5004 on the PK of a single dose of atorvastatin and atorvastatin metabolites (o-hydroxy atorvastatin and p-hydroxy atorvastatin) and simvastatin and simvastatin metabolites (simvastatin acid) in healthy participants.

    Part C: To assess the effect of multiple doses of AZD5004 on the PK of a single dose of repaglinide in healthy participants.

    Measured: Part A:Days 1-4, 7-10, 14-17, 21-24, 28-31, 35-38, 42-49 and 55-62 Part B:Days 1, 2, 4-7, 8-11, 15, 16-19, 23, 24, 30, 31, 32, 37, 38-41, 42-45 Part C:Days 1, 2, 9, 10, 11, 18, 19, 25, 26, 27, 33, 34-36

  2. Part A, Part B and Part C: Area under concentration curve from time 0 to the last quantifiable concentration (AUClast)

    Part A: To assess the effect of single dose of AZD5004 on the PK of a single dose of rosuvastatin and multiple doses of erythromycin on the PK of a single dose of AZD5004 in healthy participants.

    Part B: To assess the effect of multiple doses of AZD5004 on the PK of a single dose of atorvastatin and atorvastatin metabolites (o-hydroxy atorvastatin and p-hydroxy atorvastatin) and simvastatin and simvastatin metabolites (simvastatin acid) in healthy participants.

    Part C: To assess the effect of multiple doses of AZD5004 on the PK of a single dose of repaglinide in healthy participants.

    Measured: Part A:Days 1-4, 7-10, 14-17, 21-24, 28-31, 35-38, 42-49 and 55-62 Part B:Days 1, 2, 4-7, 8-11, 15, 16-19, 23, 24, 30, 31, 32, 37, 38-41, 42-45 Part C:Days 1, 2, 9, 10, 11, 18, 19, 25, 26, 27, 33, 34-36

  3. Part A, Part B and Part C: Maximum observed drug concentration (Cmax)

    Part A: To assess the effect of single dose of AZD5004 on the PK of a single dose of rosuvastatin and multiple doses of erythromycin on the PK of a single dose of AZD5004 in healthy participants.

    Part B: To assess the effect of multiple doses of AZD5004 on the PK of a single dose of atorvastatin and atorvastatin metabolites (o-hydroxy atorvastatin and p-hydroxy atorvastatin) and simvastatin and simvastatin metabolites (simvastatin acid) in healthy participants.

    Part C: To assess the effect of multiple doses of AZD5004 on the PK of a single dose of repaglinide in healthy participants.

    Measured: Part A:Days 1-4, 7-10, 14-17, 21-24, 28-31, 35-38, 42-49 and 55-62 Part B:Days 1, 2, 4-7, 8-11, 15, 16-19, 23, 24, 30, 31, 32, 37, 38-41, 42-45 Part C:Days 1, 2, 9, 10, 11, 18, 19, 25, 26, 27, 33, 34-36

  4. Part A, Part B and Part C: Terminal elimination half life (t½λz)

    Part A: To assess the effect of single dose of AZD5004 on the PK of a single dose of rosuvastatin and multiple doses of erythromycin on the PK of a single dose of AZD5004 in healthy participants.

    Part B: To assess the effect of multiple doses of AZD5004 on the PK of a single dose of atorvastatin and atorvastatin metabolites (o-hydroxy atorvastatin and p-hydroxy atorvastatin) and simvastatin and simvastatin metabolites (simvastatin acid) in healthy participants.

    Part C: To assess the effect of multiple doses of AZD5004 on the PK of a single dose of repaglinide in healthy participants.

    Measured: Part A:Days 1-4, 7-10, 14-17, 21-24, 28-31, 35-38, 42-49 and 55-62 Part B:Days 1, 2, 4-7, 8-11, 15, 16-19, 23, 24, 30, 31, 32, 37, 38-41, 42-45 Part C:Days 1, 2, 9, 10, 11, 18, 19, 25, 26, 27, 33, 34-36

  5. Part A, Part B and Part C: Terminal rate constant (λz)

    Part A: To assess the effect of single dose of AZD5004 on the PK of a single dose of rosuvastatin and multiple doses of erythromycin on the PK of a single dose of AZD5004 in healthy participants.

    Part B: To assess the effect of multiple doses of AZD5004 on the PK of a single dose of atorvastatin and atorvastatin metabolites (o-hydroxy atorvastatin and p-hydroxy atorvastatin) and simvastatin and simvastatin metabolites (simvastatin acid) in healthy participants.

    Part C: To assess the effect of multiple doses of AZD5004 on the PK of a single dose of repaglinide in healthy participants.

    Measured: Part A:Days 1-4, 7-10, 14-17, 21-24, 28-31, 35-38, 42-49 and 55-62 Part B:Days 1, 2, 4-7, 8-11, 15, 16-19, 23, 24, 30, 31, 32, 37, 38-41, 42-45 Part C:Days 1, 2, 9, 10, 11, 18, 19, 25, 26, 27, 33, 34-36

  6. Part A, Part B and Part C: Time to reach maximum observed concentration (tmax)

    Part A: To assess the effect of single dose of AZD5004 on the PK of a single dose of rosuvastatin and multiple doses of erythromycin on the PK of a single dose of AZD5004 in healthy participants.

    Part B: To assess the effect of multiple doses of AZD5004 on the PK of a single dose of atorvastatin and atorvastatin metabolites (o-hydroxy atorvastatin and p-hydroxy atorvastatin) and simvastatin and simvastatin metabolites (simvastatin acid) in healthy participants.

    Part C: To assess the effect of multiple doses of AZD5004 on the PK of a single dose of repaglinide in healthy participants.

    Measured: Part A:Days 1-4, 7-10, 14-17, 21-24, 28-31, 35-38, 42-49 and 55-62 Part B:Days 1, 2, 4-7, 8-11, 15, 16-19, 23, 24, 30, 31, 32, 37, 38-41, 42-45 Part C:Days 1, 2, 9, 10, 11, 18, 19, 25, 26, 27, 33, 34-36

  7. Part A, Part B and Part C: Ratio Area under concentration time curve from time 0 to infinity (RAUCinf)

    Part A: To assess the Ratio of Rosuvastatin (Rosuvastatin + AZD5004) to Rosuvastatin (alone) and Ratio of AZD5004 (AZD5004 + erythromycin) to AZD5004 (alone) based on AUCinf.

    Part B: To assess the Ratio of Atorvastatin or Simvastatin (Atorvastatin/Simvastatin + AZD5004) to Atorvastatin or Simvastatin (alone) based on AUCinf.

    Part C: To assess the Ratio of Repaglinide (Repaglinide + AZD5004) to Repaglinide (alone) based on AUCinf.

    Measured: Part A:Days 1-4, 7-10, 14-17, 21-24, 28-31, 35-38, 42-49 and 55-62 Part B:Days 1, 2, 4-7, 8-11, 15, 16-19, 23, 24, 30, 31, 32, 37, 38-41, 42-45 Part C:Days 1, 2, 9, 10, 11, 18, 19, 25, 26, 27, 33, 34-36

  8. Part A, Part B and Part C: Ratio of Area under concentration curve from time 0 to the last quantifiable concentration (RAUClast)

    Part A: To assess the Ratio of Rosuvastatin (Rosuvastatin + AZD5004) to Rosuvastatin (alone) and Ratio of AZD5004 (AZD5004 + erythromycin) to AZD5004 (alone) based on AUClast.

    Part B: To assess the Ratio of Atorvastatin or Simvastatin (Atorvastatin/Simvastatin + AZD5004) to Atorvastatin or Simvastatin (alone) based on AUClast.

    Part C: To assess the Ratio of Repaglinide (Repaglinide + AZD5004) to Repaglinide (alone) based on AUClast.

    Measured: Part A:Days 1-4, 7-10, 14-17, 21-24, 28-31, 35-38, 42-49 and 55-62 Part B:Days 1, 2, 4-7, 8-11, 15, 16-19, 23, 24, 30, 31, 32, 37, 38-41, 42-45 Part C:Days 1, 2, 9, 10, 11, 18, 19, 25, 26, 27, 33, 34-36

  9. Part A, Part B and Part C: Ratio of Maximum observed drug concentration (RCmax)

    Part A: To assess the Ratio of Rosuvastatin (Rosuvastatin + AZD5004) to Rosuvastatin (alone) and Ratio of AZD5004 (AZD5004 + erythromycin) to AZD5004 (alone) based on Cmax.

    Part B: To assess the Ratio of Atorvastatin or Simvastatin (Atorvastatin/Simvastatin + AZD5004) to Atorvastatin or Simvastatin (alone) based on Cmax.

    Part C: To assess the Ratio of Repaglinide (Repaglinide + AZD5004) to Repaglinide (alone) based on Cmax.

    Measured: Part A:Days 1-4, 7-10, 14-17, 21-24, 28-31, 35-38, 42-49 and 55-62 Part B:Days 1, 2, 4-7, 8-11, 15, 16-19, 23, 24, 30, 31, 32, 37, 38-41, 42-45 Part C:Days 1, 2, 9, 10, 11, 18, 19, 25, 26, 27, 33, 34-36

Secondary outcomes (1)

  1. Part A, Part B and Part C: Number of participants with adverse events (AEs) and adverse event of special interest (AESI)

    To examine the safety and tolerability of AZD5004 alone and in combination with, the following drugs in healthy participants as listed below Part A: rosuvastatin or erythromycin Part B: atorvastatin and simvastatin Part C: repaglinide

    Measured: Part A: From screening (Day -28 to -2 ) to followup visit (Day 65) Part B: From screening (Day -28 to -2) to followup visit (Day 48) Part C: From screening (Day -28 to -2) to followup visit (Day 38)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2025
  2. Study start6 May 2025
  3. Primary completion3 Oct 2025
  4. Study completion3 Oct 2025

Resources

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
Factorial
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06948747
Sponsor's protocol ID
D7260C00017
Status last verified
Oct 2025
First submitted
28 Apr 2025
Last updated
10 Oct 2025
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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AZD5004, Rosuvastatin and Erythromycin 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 6 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 10 Oct 2025. 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?

Part A, Part B and Part C: Area under concentration time curve from time 0 to infinity (AUCinf) (time frame: Part A:Days 1-4, 7-10, 14-17, 21-24, 28-31, 35-38, 42-49 and 55-62 Part B:Days 1, 2, 4-7, 8-11, 15, 16-19, 23, 24, 30, 31, 32, 37, 38-41, 42-45 Part C:Days 1, 2, 9, 10, 11, 18, 19, 25, 26, 27, 33, 34-36). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06948747.

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 10 Oct 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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