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Corticosteroid

Baxdrostat and Itraconazole for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 kg/m2 inclusive and weigh >= 50 kg and <= 120 kg
Must not have
History of any treatment with QT prolongation drugs
Participants who have previously received baxdrostat
Timeline
Screening 3 weeks
Treatment Varies
Follow Up period 1: days 1 to 6 (pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, and 120 hours post-dose); period 3: days 9 to 17 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours)
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see how taking itraconazole affects how the body processes baxdrostat.

Who is the study for?
This trial is for healthy men and women aged 18 to 55 who are not able to have children. Participants should have good veins for drawing blood, weigh between 50-120 kg, and have a BMI of 18-32 kg/m2.
What is being tested?
The study is looking at how the body processes Baxdrostat alone and when taken with another drug called Itraconazole. It's designed to understand any changes in the way Baxdrostat works when combined with Itraconazole.
What are the potential side effects?
As this trial involves healthy participants, specific side effects aren't listed but generally could include reactions at the site of injection, potential liver enzyme changes due to itraconazole, or other mild systemic symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant, as confirmed by tests during screening and before the study starts.
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My BMI is between 18 and 32, and my weight is between 50kg and 120kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have taken medication that can affect my heart's rhythm.
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I have previously taken baxdrostat.
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I have no conditions that affect how my body handles medicine.
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I have had liver problems due to medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~period 1: days 1 to 6 (pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, and 120 hours post-dose); period 3: days 9 to 17 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours)
This trial's timeline: 3 weeks for screening, Varies for treatment, and period 1: days 1 to 6 (pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, and 120 hours post-dose); period 3: days 9 to 17 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area Under Plasma Concentration-Time Curve From Time Zero To Infinity (AUCinf)
Maximum Observed Plasma Drug Concentration (Cmax)
Secondary study objectives
Apparent Total Body Clearance (CL/F)
Apparent Volume Of Distribution Based On The Terminal Phase (Vz/F)
Area Under Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast)
+9 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Baxdrostat and ItraconazoleExperimental Treatment2 Interventions
Participants will receive single dose of baxdrostat tablet orally on Day 1 in Period 1, followed by itraconazole capsule orally twice a day on Day 6 and once daily on Days 7 to 8 in Period 2, and then single dose of baxdrostat tablet orally on Day 9 with itraconazole capsule orally once daily on Days 9 to 16 in Period 3.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baxdrostat
2024
Completed Phase 1
~50
Itraconazole
2017
Completed Phase 2
~830

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,379 Previous Clinical Trials
288,740,276 Total Patients Enrolled
~9 spots leftby Oct 2025
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