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

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.

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.