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

Study identifier:D7260C00017

ClinicalTrials.gov identifier:NCT06948747

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

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

Medical condition

Healthy Participants

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD5004, Rosuvastatin, Erythromycin, Atorvastatin, Simvastatin, Repaglinide

Sex

All

Estimated Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 06 May 2025

Estimated Primary Completion Date: 15 Oct 2025

Estimated Study Completion Date: 29 Oct 2025

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Factorial Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 May 2025 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- 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.

Exclusion Criteria

- 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.
- 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.

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Arms	Assigned Interventions
Experimental: Part A Participants 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.	Drug: AZD5004 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. Drug: Rosuvastatin Participants will receive single oral tablets of rosuvastatin 10mg on Days 1, 7, 14, 21, 28, and 35. Drug: Erythromycin 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.
Experimental: Part B Participants 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.	Drug: AZD5004 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. Drug: Atorvastatin Participants will receive single oral doses of 40 mg atorvastatin on Days 4, 8, 16, 38, and 42. Drug: Simvastatin Participants will receive single oral doses of 20 mg simvastatin on Days 1 and 31.
Experimental: Part C Participants 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.	Drug: AZD5004 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. Drug: Repaglinide Participants will receive single oral doses of 0.5 mg repaglinide on Days 1, 10, 26, and 34.

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]