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

• Status: Completed
• Trial end date: 2024-05-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Treatments: Moxifloxacin

Criteria

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.