NCT06357520

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

An Open-label, Fixed Sequence Study in Healthy Participants to Assess the Pharmacokinetics of Baxdrostat When Administered Alone and in Combination With Itraconazole

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this study is to assess the effect of itraconazole on the pharmacokinetic (PK) of baxdrostat.

Detailed description

This study will be an open-label, 3-period fixed sequence study conducted at a single Clinical Unit. The study will comprise of: * A Screening Period of maximum 28 days * Period 1: Period 1 will start from Day -1 to Day 6 (followed by pharmacokinetic (PK) sampling of baxdrostat). Baxdrostat administration on Day 1 to Day 6 * Period 2: Period 2 will start from Day 6 (after the last PK sample in period 1) to Day 8. Itraconazole administration on Days 6 to 8 (twice a day \[BID\] on Day 6 and once daily \[QD\] on Days 7 and 8) * Period 3: Period 3 will start from Day 9 to Day 17. Baxdrostat administration on Day 9 and itraconazole administration on Days 9 to 16 QD * A Final Follow-up Visit at 7 to 14 days after the last baxdrostat PK sample in Period 3 All participants will receive 2 single doses of baxdrostat and 12 doses of itraconazole, under fed conditions.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Baxdrostat	Baxdrostat tablet will be administered orally.
DRUG	Itraconazole	Itraconazole capsule will be administered orally.

Timeline

• Start date: 2024-04-16
• Primary completion: 2024-06-17
• Completion: 2024-06-17
• First posted: 2024-04-10
• Last updated: 2024-07-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study