A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 as Well as the Impact of AZD4144 on the Pharmacokinetics of Rosuvastatin and Furosemide in Healthy Participants

Launched by ASTRAZENECA · Jul 1, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new drug called AZD4144 to see how safe it is, how well it is tolerated, and how it works in the body, compared to a placebo (a substance with no active treatment). The study has three parts: the first two parts will focus on the safety and effects of AZD4144 in healthy participants, while the third part will look at how AZD4144 interacts with another medication called rosuvastatin, which is used to lower cholesterol. The trial is currently recruiting healthy adults aged 18 and older, with specific criteria for participants from Japanese and Chinese backgrounds.

To be eligible for the trial, participants must meet certain health requirements, such as having a healthy weight and no serious medical conditions that could affect the study results. Women must have a negative pregnancy test, and both men and women must agree to use effective contraception if they are of childbearing potential. Those who participate can expect to undergo various assessments to monitor their health and the effects of the drug. It’s important to note that certain health issues and medications may exclude individuals from participating in the study. Overall, this trial aims to gather important information that could help in developing new treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
• • Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.
• • Females of non-childbearing potential must be confirmed at the Screening Visit.
• • Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
• • Have a BMI between 18 and 32 kg/m2 inclusive at both Screening and Admission and weigh at least 45 kg at Screening.
• • For healthy Japanese cohorts (Part A2 and Part B2): healthy male and female participants are to be Japanese, defined as having both parents and 4 grandparents who are Japanese. This includes second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan.
• • For healthy Chinese cohort (Part A3): healthy male and female Chinese participants for whom both parents and all grandparents are Chinese and not lived outside of China for more than 10 years.
• Exclusion Criteria:
• • History of any clinically important disease or disorder 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.
• • Clinically significant serious active and chronic infections.
• • Any history or evidence of TB (active or latent).
• • Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection.
• • Bacillus Calmette Guérin vaccine within one year prior to signing the ICF.
• • Any abnormal laboratory values at the Screening Visit or on Admission to the Clinical Unit.
• • Any positive result on Screening for serum Hepatitis B surface antigen (HBsAg), anti-Hepatitis B core (HBc), hepatitis C antibody, or Human immunodeficiency virus (HIV).
• • Any clinically important abnormalities in ECG.
• • History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
• • Known hypersensitivity to furosemide and rosuvastatin (for Part C only)
• • History of alcohol abuse or excessive intake of alcohol or current smokers or those who have smoked or used nicotine products.
• • Use of drugs with enzyme inducing properties or of any prescribed or nonprescribed medication or of systemic hormonal contraceptives.
• • Clinical signs and symptoms consistent with COVID-19.