Research Site
Brooklyn, Maryland, 21225, United States
NCT Number: NCT06974565
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.
Looking for future studies?
Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Brooklyn, Maryland, 21225, United States
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 will comprise -
Participants will be randomized to one of the 2 treatment sequences -
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
AZD2389 will be administered orally.
Quinidine will be administered orally.
Time frame: Day 1 to Day 10
To assess the effect of quinidine on the PK of AZD2389.
Time frame: Day 1 to Day 10
To assess the effect of quinidine on the PK of AZD2389.
Time frame: Day 1 to Day 10
To assess the effect of quinidine on the PK of AZD2389.
Time frame: Day 1 to Day 10
To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Time frame: Day 1 to Day 10
To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Time frame: Day 1 to Day 10
To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Time frame: Day 1 to Day 10
To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Time frame: Day 1 to Day 10
To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Time frame: Day 1 to Day 10
To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Time frame: Day 1 to Day 10
To assess the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Time frame: Day 1 to Day 10
To assess the urine PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Time frame: Day 1 to Day 10
To assess the urine PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Time frame: Day 1 to Day 10
To assess the urine PK of AZD2389 when AZD2389 is administered alone or in combination with quinidine.
Time frame: Baseline, Day 1 to Day 10
To assess the pharmacodynamics (PD) of AZD2389 by assessment of inhibition of FAP activity in plasma after single oral dose of AZD2389 alone or in combination with quinidine.
Time frame: From Screening (Day -28 to Day -2) to Follow-up visit (upto 8 weeks)
To assess the safety and tolerability of a single oral dose of AZD2389 alone or in combination with quinidine in healthy participants.
AstraZeneca
Industry
An Open-label, Randomized, Cross-over, Single Dose Study in Healthy Participants to Assess the Pharmacokinetics of AZD2389 When Administered Alone and in Combination With Quinidine
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06973005
Advanced Chronic Liver Disease, Digestive System Diseases
Brooklyn, Maryland, United States
View Trial DetailsNCT05663944
Advanced Chronic Liver Disease, Digestive System Diseases
Nottingham, Nottinghamshire, United Kingdom
View Trial DetailsNCT05602870
Advanced Chronic Liver Disease, Alcohol-Induced Disorders
Montpellier, France
View Trial DetailsNCT05475015
Advanced Chronic Liver Disease, Cirrhosis, Liver
Shenyang, Liaoning, China
View Trial Details