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

NCT06194032

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: Healthy Participants

Interventions: Baxdrostat, Placebo, Moxifloxacin

Countries: Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility 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.
Locations (1)
  • Berlin, Germany