Healthy Participants Clinical Trial
Official title:
An Open-label, Fixed Sequence Study in Healthy Participants to Assess the Pharmacokinetics of Baxdrostat When Administered Alone and in Combination With Itraconazole
The main purpose of this study is to assess the effect of itraconazole on the pharmacokinetic (PK) of baxdrostat.
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. ;
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