NCT06194032

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

A Single-centre, Randomised, Double-blind, Placebo-controlled, Four-Way Crossover Phase I Thorough QTc Study to Investigate the Effect on QTcF of Single Doses of Baxdrostat Compared With Placebo, Using Open-label Moxifloxacin as a Positive Control, in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This is a randomised, placebo-controlled, double-blind, 4-way crossover TQT study to assess the effect of single oral doses of baxdrostat on the QTcF compared to placebo using a concentration-QTcF analysis, and with open-label moxifloxacin as positive control, in 28 healthy participants, performed at a single clinical unit. The study will comprise of: * a screening period of maximum 28 days, * four treatment periods during which participants will be resident at the Clinical Unit from Treatment Period Day -1 until at least 48 hours after dosing (Treatment Period Day 3). * a final Follow-up Visit within 7 to 10 days following discharge after Visit 5 Participants will each receive a single dose of all treatments in a cross-over design over 4 treatment periods. Participants will be randomised to 1 of 4 treatment sequences with equal allocation regarded as a Williams design of order 4. Treatment Periods will be separated by a washout period of at least 7 days but no more than 9 days.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Baxdrostat	Participants will receive baxdrostat as two separate doses.
DRUG	Placebo	Participants will receive baxdrostat matching placebo.
DRUG	Moxifloxacin	Participants will receive a single dose moxifloxacin

Timeline

• Start date: 2024-02-29
• Primary completion: 2024-05-13
• Completion: 2024-05-13
• First posted: 2024-01-08
• Last updated: 2025-04-25

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study