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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

NCT06491550

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: Healthy Participants

Interventions: AZD4144- Part A, Placebo- Part A, AZD4144- Part B, Placebo- Part B, Rosuvastatin and Furosemide- Part C

Countries: United States

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 participants, in Part A and Part B. Part C of this study will investigate the possibility of drug-drug interaction (DDI) between IV AZD4144 and oral rosuvastatin and furosemide by evaluating the PK of rosuvastatin and furosemide when administered alone and in combination with single IV dose of AZD4144

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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.

Locations (2)

Glendale, California, United States
Brooklyn, Maryland, United States