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

NCT06194032 | Completed Phase 1 FDA Drug

• 2 other identifiers: D6970C000042023-506108-23-00
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Keywords

Aldosterone synthase inhibitor; QT/QTc interval; Moxifloxacin

Outcome Measures

Primary Outcomes (1)

• Placebo corrected change from baseline in QTcF (ΔΔQTcF)

  The effect of single doses of baxdrostat on QTcF compared to placebo using a concentration-QTcF analysis will be assessed.

  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

Secondary Outcomes (29)

• Heart Rate (HR)

  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

• RR interval

  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

• PR interval

  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

• QRS interval

  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

• Change from baseline in Heart rate (ΔHR)

  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

Study Arms (4)

Treatment Sequence ABCD

EXPERIMENTAL

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.

Drug: Baxdrostat; Drug: Placebo; Drug: Moxifloxacin

Treatment Sequence BDAC

EXPERIMENTAL

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.

Drug: Baxdrostat; Drug: Placebo; Drug: Moxifloxacin

Treatment Sequence CADB

EXPERIMENTAL

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.

Drug: Baxdrostat; Drug: Placebo; Drug: Moxifloxacin

Treatment Sequence DCBA

EXPERIMENTAL

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.

Drug: Baxdrostat; Drug: Placebo; Drug: Moxifloxacin

Interventions

Baxdrostat DRUG

Participants will receive baxdrostat as two separate doses.

Treatment Sequence ABCD; Treatment Sequence BDAC; Treatment Sequence CADB; Treatment Sequence DCBA

Placebo DRUG

Participants will receive baxdrostat matching placebo.

Treatment Sequence ABCD; Treatment Sequence BDAC; Treatment Sequence CADB; Treatment Sequence DCBA

Moxifloxacin DRUG

Participants will receive a single dose moxifloxacin

Treatment Sequence ABCD; Treatment Sequence BDAC; Treatment Sequence CADB; Treatment Sequence DCBA

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females must have a negative pregnancy test.
• Have a Basal Metabolic index (BMI) between 19 and 30 kg/m2 inclusive and weigh at least 50 kg.

You may not qualify if:

• History of any clinically significant disease or disorder.
• History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• History of additional risk factors for Torsade de Pointes.
• History of neoplastic disease.
• Family history of sudden cardiac death.
• Any skin condition likely to interfere with ECG electrode placement or adhesion.
• Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of drug.
• Any clinically significant abnormalities at screening and first admission in rhythm, conduction, or morphology of the 12-lead resting ECG and any clinically important abnormalities in the 12-lead ECG as considered by the investigator.
• Participant has clinical signs and symptoms consistent with COVID-19.
• Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to screening.
• Positive screen for drugs of abuse, alcohol or cotinine at screening or on each admission to the Clinical Unit.
• Participants who have previously received Baxdrostat.
• Participants with any special dietary restrictions such as participants who are lactose intolerant or are vegetarians/vegans.
• Participants who cannot communicate reliably with the investigator and/or are not able to read, speak, and understand the local language.
• Vulnerable participants, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Berlin, 14050, Germany

Location

Related Links

• D6970C00004\_Redacted\_CSR Synopsis
• Results posted on AZCT.com

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This study is double-blinded with regard to treatment (baxdrostat or placebo), for all placebo-controlled dose groups (groups where placebo and active substance is given in a cohort, ie, the sponsor, the investigator, all clinical staff involved in the clinical study (except for the unblinded pharmacist), the participants, and the study monitor will remain blinded, unless safety concerns or a regulatory requirement necessitate unblinding). Moxifloxacin will be administered as an open-label positive control in this study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 8, 2024
• Study Start: February 29, 2024
• Primary Completion: May 13, 2024
• Study Completion: May 13, 2024
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

DE (1)