A Study to Investigate the Pharmacokinetics of Baxdrostat When Given Alone and in Combination With Itraconazole in Healthy Participants
Completed · Phase 1
Conditions studied: Healthy Participants
In brief
The main purpose of this study is to assess the effect of itraconazole on the pharmacokinetic (PK) of baxdrostat.
Key facts
- Study ID
- NCT06357520
- Run by
- AstraZeneca
- People needed
- 14
- Starts
- 2024-04-16
- Expected to finish
- 2024-06-17
- Last updated by the study team
- 2024-07-03
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy male and/or female participants of non-childbearing potential aged 18 to 55 years with suitable veins for cannulation or repeated venipuncture.
- All female participants must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit (Study Day -1).
- Have a body mass index between 18 and 32 kilograms per meter square (kg/m2) inclusive and weigh greater than or equal to (>=) 50 kilograms (kg) and less than or equal to <=) 120 kg.
You may not qualify if…
- History of any clinically important disease or disorder which, in the opinion of the principal investigator (PI), may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- History of drug-related hepatic toxicity.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
- History of any treatment with QT prolongation drugs.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to baxdrostat or itraconazole.
- Participants who have previously received baxdrostat.
Where it is running
- Research Site — Brooklyn, Maryland, United States
Full record on ClinicalTrials.gov
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