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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2024-05-13

Brief Summary

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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.

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Detailed Description

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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

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Baxdrostat

Intervention Type DRUG

Participants will receive baxdrostat as two separate doses.

Placebo

Intervention Type DRUG

Participants will receive baxdrostat matching placebo.

Moxifloxacin

Intervention Type DRUG

Participants will receive a single dose moxifloxacin

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.

Group Type EXPERIMENTAL

Baxdrostat

Intervention Type DRUG

Participants will receive baxdrostat as two separate doses.

Placebo

Intervention Type DRUG

Participants will receive baxdrostat matching placebo.

Moxifloxacin

Intervention Type DRUG

Participants will receive a single dose moxifloxacin

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.

Group Type EXPERIMENTAL

Baxdrostat

Intervention Type DRUG

Participants will receive baxdrostat as two separate doses.

Placebo

Intervention Type DRUG

Participants will receive baxdrostat matching placebo.

Moxifloxacin

Intervention Type DRUG

Participants will receive a single dose moxifloxacin

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.

Group Type EXPERIMENTAL

Baxdrostat

Intervention Type DRUG

Participants will receive baxdrostat as two separate doses.

Placebo

Intervention Type DRUG

Participants will receive baxdrostat matching placebo.

Moxifloxacin

Intervention Type DRUG

Participants will receive a single dose moxifloxacin

Interventions

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Baxdrostat

Participants will receive baxdrostat as two separate doses.

Intervention Type DRUG

Placebo

Participants will receive baxdrostat matching placebo.

Intervention Type DRUG

Moxifloxacin

Participants will receive a single dose moxifloxacin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes