A Study to Investigate the Effect on QTcF of Baxdrostat Compared With Placebo, Using Moxifloxacin as a Positive Control, in Healthy Participants

Sponsor
AstraZeneca
Study ID
NCT06194032
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Baxdrostat — DRUG
    Participants will receive baxdrostat as two separate doses.
  • Placebo — DRUG
    Participants will receive baxdrostat matching placebo.
  • Moxifloxacin — DRUG
    Participants will receive a single dose moxifloxacin

Study Details

This study will assess the effect of single oral doses of baxdrostat on the ECG interval measured from the onset of the QRS complex to the end of the T wave (QT) interval corrected for HR using Fridericia's formula (QTcF) compared to placebo using a concentration-QTcF analysis, and with moxifloxacin as positive control, in healthy participants.

Key Dates

Start date
Feb 29, 2024
Status verified
Apr 2025
Primary completion
May 13, 2024
Completion
May 13, 2024

Study Design

Enrollment
28 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Sequence ABCD
    Dummy sequence according to CSP: Participants will receive a single dose of all 4 treatments (ABCD) in a crossover design with a washout period of at least 7 days between each study dose administration.
  • Experimental: Treatment Sequence BDAC
    Dummy sequence according to CSP: Participants will receive a single dose of all 4 treatments (BDAC) in a crossover design with a washout period of at least 7 days between each study dose administration.
  • Experimental: Treatment Sequence CADB
    Dummy sequence according to CSP: Participants will receive a single dose of all 4 treatments (CADB) in a crossover design with a washout period of at least 7 days between each study dose administration.
  • Experimental: Treatment Sequence DCBA
    Dummy sequence according to CSP: Participants will receive a single dose of all 4 treatments (DCBA) in a crossover design with a washout period of at least 7 days between each study dose administration.

Primary Outcome Measure

Placebo corrected change from baseline in QTcF (ΔΔQTcF) [ Time Frame: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose ]

Related Studies