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Corticosteroid

Baxdrostat and Itraconazole for Healthy Subjects

Q: Are there currently openings for participants in this clinical trial?

The trial, actively seeking participants according to clinicaltrials.gov, was initially posted on April 16th, 2024 and last revised on April 24th of the same year.

Q: Is it feasible for me to be a participant in this clinical investigation?

To be considered for this trial, individuals must meet the criteria of being in good health and aged between 18 to 55 years old. The study aims to recruit approximately 14 participants.

Q: What are the safety profiles of Baxdrostat and Itraconazole in relation to patient usage?

The safety evaluation of Baxdrostat and Itraconazole by our team at Power is rated as 1, indicating minimal safety data due to the early phase nature of the trial.

Q: Is this clinical trial open to individuals below the age of 70?

For this research study, individuals must be at least 18 years old but not exceed the age of 55 to qualify for enrollment.

Q: What are the primary goals of this medical study in question?

The primary objective of this clinical trial, assessed during Period 1 spanning Days 1 to 6 and Period 3 from Days 9 to 17 at specified intervals post-dose, is the determination of Area Under Plasma Concentration-Time Curve From Time Zero To Infinity (AUCinf). Secondary endpoints include determining Apparent Volume Of Distribution Based On The Terminal Phase (Vz/F), evaluating Mean Residence Time (MRTinf), and assessing Area Under Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast) for baxdrostat when administered alone or in conjunction with itraconazole.

Phase 1

Recruiting

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

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

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

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)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area Under Plasma Concentration-Time Curve From Time Zero To Infinity (AUCinf)

Maximum Observed Plasma Drug Concentration (Cmax)

Secondary outcome measures

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

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

Itraconazole

2017

Completed Phase 2

~780

0 / 2Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,274 Previous Clinical Trials

288,613,350 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently openings for participants in this clinical trial?

"The trial, actively seeking participants according to clinicaltrials.gov, was initially posted on April 16th, 2024 and last revised on April 24th of the same year."

Answered by AI

Is it feasible for me to be a participant in this clinical investigation?

"To be considered for this trial, individuals must meet the criteria of being in good health and aged between 18 to 55 years old. The study aims to recruit approximately 14 participants."

Answered by AI

What are the safety profiles of Baxdrostat and Itraconazole in relation to patient usage?

"The safety evaluation of Baxdrostat and Itraconazole by our team at Power is rated as 1, indicating minimal safety data due to the early phase nature of the trial."

Answered by AI

Is this clinical trial open to individuals below the age of 70?

"For this research study, individuals must be at least 18 years old but not exceed the age of 55 to qualify for enrollment."

Answered by AI

What are the primary goals of this medical study in question?

"The primary objective of this clinical trial, assessed during Period 1 spanning Days 1 to 6 and Period 3 from Days 9 to 17 at specified intervals post-dose, is the determination of Area Under Plasma Concentration-Time Curve From Time Zero To Infinity (AUCinf). Secondary endpoints include determining Apparent Volume Of Distribution Based On The Terminal Phase (Vz/F), evaluating Mean Residence Time (MRTinf), and assessing Area Under Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast) for baxdrostat when administered alone or in conjunction with itraconazole."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Investigate the Pharmacokinetics of Baxdrostat When Given Alone and in Combination With Itraconazole in Healthy Participants

2024. "A Study to Investigate the Pharmacokinetics of Baxdrostat When Given Alone and in Combination With Itraconazole in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06357520.

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