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

Last updated: May 13, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

Erythromycin

Rosuvastatin

AZD5004

Clinical Study ID

NCT06948747
D7260C00017
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 onadmission to the Clinical Unit.

  • Female(s) of childbearing potential if heterosexually active, must agree to use anapproved 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 trialparticipants throughout the clinical trial.

  • Have a body mass index (BMI) between ≥ 20.0 and ≤ 35 kg/m2 (at the time ofscreening) inclusive and weigh at least 50 kg.

Exclusion

Exclusion Criteria:

  • History of any clinically important disease or disorder (liver transplant, liverdisease, positive for serum HBsAg (Hepatitis B surface antigen) OR anti-HBcAb (Hepatitis B core antibody), positive for anti-HCV (Hepatitis C virus), history ofcirrhosis and/or hepatic decompensation, cardiovascular disease, neuromuscular orneurogenic 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 othercondition known to interfere with absorption, distribution, metabolism, or excretionof drugs.

  • Any clinically important illness, medical/surgical procedure, or trauma.

  • Any laboratory values with deviations or clinically important abnormalities inclinical chemistry, hematology, or urinalysis at the Screening Visit or on admissionto the Clinical Unit.

  • Significant hepatic disease as judged by the investigator.

  • Any positive result on screening for serum HBsAg, HBcAb or HIV (Humanimmunodeficiency virus).

  • Any clinically important abnormalities in rhythm, conduction, or morphology of theresting 12 lead ECG, at screening

  • Abnormal vital signs.

  • Uncontrolled thyroid disease or history/family history of medullary thyroidcarcinoma (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 alcoholas judged by the investigator. Excessive intake of alcohol defined as the regularconsumption of more than 24 g of alcohol per day for men or 12 g of alcohol per dayfor females.

  • Positive screen for drugs of abuse, or alcohol or cotinine at screening or on eachadmission to the Clinical Unit.

  • History of severe allergy/hypersensitivity or ongoing clinically importantallergy/hypersensitivity.

  • Excessive intake of caffeine-containing drinks or food

  • History of psychosis or bipolar disorder or major depressive disorder or suicideattempt or suicidal ideation.

Study Design

Total Participants: 48
Treatment Group(s): 6
Primary Treatment: Erythromycin
Phase: 1
Study Start date:
May 06, 2025
Estimated Completion Date:
October 29, 2025

Study 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.

Connect with a study center

  • Research Site

    Brooklyn, Maryland 21225
    United States

    Active - Recruiting

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