Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT06357520
Brief 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.
Study:
NCT06357520
Study Brief:
Protocol Section:
NCT06357520