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NCT06948747CompletedPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 10 Oct 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
49 (actual)
First submitted
28 Apr 2025
Start date
6 May 2025
Primary completion date
3 Oct 2025
Lead sponsor
AstraZeneca
NCT number
NCT06948747

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 49
  • From 6 May 2025 to the primary completion date, 3 Oct 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

  • History of Type 1 or Type 2 diabetes mellitus (DM).
  • 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.
  • Significant hepatic disease as judged by the investigator.
  • Uncontrolled thyroid disease or history/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2).
  • 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.
  • History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
  • History of psychosis or bipolar disorder or major depressive disorder or suicide attempt or suicidal ideation.

Lab values

  • 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 Hemoglobin A1c ≥ 6.5% (≥ 48 mmol/mol) at screening.
  • 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.
  • Any positive result on screening for serum HBsAg, HBcAb or HIV (Human immunodeficiency virus).

Other

  • Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12 lead ECG, at screening
  • Abnormal vital signs.
  • Current smokers or those who have smoked or used nicotine products.
  • Excessive intake of caffeine-containing drinks or food

Who the study is looking for

  • 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.

Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
BrooklynUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.