Status:
COMPLETED
A Study to Investigate the Effect on QTcF of Baxdrostat Compared With Placebo, Using Moxifloxacin as a Positive Control, in Healthy Participants
Lead Sponsor:
AstraZeneca
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 Frider...
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 ana...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2024
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06194032
Start Date
February 29 2024
End Date
May 13 2024
Last Update
April 25 2025
Active Locations (1)
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1
Research Site
Berlin, Germany, 14050