Research Site
Brooklyn, Maryland, 21225, United States
NCT Number: NCT06846528
The purpose of this study is to assess the pharmacokinetics (PK) of AZD2389 when administered alone and in combination with itraconazole in healthy participants.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Brooklyn, Maryland, 21225, United States
This study will be an open-label, fixed sequence, Drug-Drug Interaction (DDI) study consisting of 3 periods.
The study will comprise:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
AZD2389 is administered orally
Itraconazole is administered orally
Time frame: Day 1 to Day 8
To assess the effect of itraconazole on the Cmax of AZD2389.
Time frame: Day 1 to Day 8
To assess the effect of itraconazole on the AUCinf of AZD2389.
Time frame: Day 1 to Day 8
To assess the effect of itraconazole on the AUClast of AZD2389.
Time frame: Day 1 to Day 8
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole
Time frame: Day 1 to Day 8
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole
Time frame: Day 1 to Day 8
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.
Time frame: Day 1 to Day 8
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.
Time frame: Day 1 to Day 8
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.
Time frame: Day 1 to Day 8
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.
Time frame: Day 1 to Day 8
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.
Time frame: Day 1 to Day 8
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.
Time frame: Day 1 to Day 8
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.
Time frame: Day 1 to Day 8
To describe the plasma PK of AZD2389 when AZD2389 is administered alone or in combination with itraconazole.
Time frame: Day 1 to Day 8
To evaluate 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 itraconazole.
Time frame: From Screening (Day -29 to Day -2) up to 8 weeks
To assess the safety and tolerability of a single oral dose of AZD2389 alone or in combination with itraconazole in healthy participants.
AstraZeneca
Industry
An Open-label, Fixed Sequence Study in Healthy Participants to Assess the Pharmacokinetics of AZD2389 When Administered Alone and in Combination With Itraconazole
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.
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