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

Part of paid clinical trials in Brooklyn, Maryland.

Sponsor
AstraZeneca
Study ID
NCT06357520
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Baxdrostat — DRUG
    Baxdrostat tablet will be administered orally.
  • Itraconazole — DRUG
    Itraconazole capsule will be administered orally.

Study Details

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

Key Dates

Start date
Apr 16, 2024
Status verified
Jun 2024
Primary completion
Jun 17, 2024
Completion
Jun 17, 2024

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • 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.

Primary Outcome Measure

Area Under Plasma Concentration-Time Curve From Time Zero To Infinity (AUCinf) [ Time Frame: 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) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteBrooklynMaryland21225-

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Research Site· Brooklyn, MD

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