Status:
COMPLETED
A Study to Investigate the Pharmacokinetics of AZD2389 in Healthy Participants When Administered Alone and in Combination With Quinidine
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Parexel
Conditions:
Advanced Chronic Liver Disease
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the pharmacokinetics (PK) and safety of AZD2389 when administered alone and in combination with quinidine in healthy participants.
Detailed Description
This is a 2-way cross-over study to evaluate the effect of quinidine on the PK of AZD2389. The study will include 2 Treatments - Treatment A - AZD2389 Treatment B - AZD2389 + quinidine The study wil...
Eligibility Criteria
Inclusion
- Healthy male and female (of non-childbearing potential) participants with suitable veins for cannulation or repeated venipuncture.
- All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
- 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 study specific contraception methods from the time of first administration of study intervention administration until 3 months after the study Follow-up Visit.
- Have a body mass index between 18 and 32 kg/m2, inclusive, and weigh at least 50 kg at the Screening Visit.
Exclusion
- History of any clinically important disease or disorder.
- 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 abnormalities in hematology, clinical chemistry, urinalysis, coagulation results or other laboratory values and vital signs.
- Any positive result on Screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus (HIV).
- Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram (ECG) at Screening.
- Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
- Current smokers or those who have smoked or used nicotine products within the previous 3 months prior to screening.
- Positive screen for drugs of abuse, or alcohol or cotinine at Screening.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
- History of hypersensitivity to dipeptidyl peptidase 4 (DPP4) inhibitors.
Key Trial Info
Start Date :
May 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06974565
Start Date
May 12 2025
End Date
July 18 2025
Last Update
July 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Brooklyn, Maryland, United States, 21225