Status:
COMPLETED
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
Lead Sponsor:
AstraZeneca
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study consists of 3 parts: Part A, Part B and Part C. This study will compare the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD4144 with placebo in healthy partici...
Detailed Description
This is a Phase I, randomized study in healthy participants and consists of 3 parts; Part A, Part B and Part C. Part A and B are single-blind, placebo-controlled with single ascending dose (SAD) and m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2025
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT06491550
Start Date
July 15 2024
End Date
June 11 2025
Last Update
July 4 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Glendale, California, United States, 91206
2
Research Site
Brooklyn, Maryland, United States, 21225