Study identifier:D6970C00005
ClinicalTrials.gov identifier:NCT06357520
EudraCT identifier:N/A
CTIS identifier:N/A
An open-label, fixed sequence study in healthy participants to assess the pharmacokinetics of baxdrostat when administered alone and in combination with itraconazole
Healthy Participants
Phase 1
Yes
Itraconazole, Baxdrostat
All
14
Interventional
18 Years - 55 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Other
Verified 01 Jan 2025 by AstraZeneca
AstraZeneca
-
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.
Location
Location
Brooklyn, MD, United States, 21225
Arms | Assigned Interventions |
---|---|
Experimental: Baxdrostat and Itraconazole 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. | Drug: Baxdrostat Baxdrostat tablet will be administered orally. Other Name: CIN-107 |
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