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

Conditions

Healthy Participants Pharmacokinetic (PK)Pharmacodynamic (PD)Drug-drug interaction (DDI)Single ascending dose (SAD)Multiple ascending dose (MAD)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase I Randomized, Single-blind, Placebo-controlled, and Sequential Group Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 Following Single and Multiple Ascending Doses Via Intravenous Administration, and an Open-label, 2-Period, 2-Sequence, Cross-over Study to Assess the Effects of Intravenous AZD4144 on Rosuvastatin and Furosemide Pharmacokinetics in Healthy Participants

Quick Facts

Study Start:2024-07-15

Study Completion:2025-06-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06491550

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Locations (Sites)

Research Site

Glendale, California, 91206

United States

Research Site

Brooklyn, Maryland, 21225

United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-15

Study Completion Date2025-06-11

Study Record Updates

Study Start Date2024-07-15

Study Completion Date2025-06-11

Terms related to this study

Keywords Provided by Researchers

Pharmacokinetic (PK)
Pharmacodynamic (PD)
Drug-drug interaction (DDI)
Single ascending dose (SAD)
Multiple ascending dose (MAD)

Additional Relevant MeSH Terms

Healthy Participants