This was a Phase 1, open-label, single dose study in healthy male subjects. The goals of this clinical trial were to determine how baxdrostat might be absorbed and metabolized using radioactive [14C] labeled baxdrostat. Subjects were administered a single oral dose of 10 mg containing approximately 100 μCi of [14C] baxdrostat. Subjects were to be confined to the study site for 9 to 15 days for blood, urine, and feces collections.

Subjects must meet the following inclusion criteria:

• Be males of any race between 18 and 55 years of age
• Have a body mass index between 18.0 and 32.0 kg/m2
• Be in good health, determined by no clinically significant findings from medical history
• Have normal renal function, defined as estimated GFR ≥70 mL/min/1.73 m2
• Agree to use contraception
• Be able to comprehend and willing to sign an ICF and to abide by the study restrictions
• Have a history of a minimum of 1 bowel movement per day
• Agree to refrain from donation of sperm from check-in until 90 days after discharge

Main Exclusion Criteria:

• Significant history or clinical manifestation of any diseases as determined by the investigator
• Prolonged QTcF (>450 msec)
• Confirmed (eg, 2 consecutive measurements) systolic BP >140 or <90 mmHg, diastolic BP >90 or <50 mmHg, and pulse rate >100 or <45 beats per minute (bpm).
• Postural tachycardia (ie, >30 bpm upon standing) or orthostatic hypotension (ie, a fall in systolic BP of ≥20 mmHg or diastolic BP of ≥10 mmHg upon standing).
• Serum potassium >upper limit of normal (5.3 mmol/L; ULN) of the reference range and serum sodium <lower limit of normal (135 mmol/L) of the reference range
• Aspartate aminotransferase, alanine aminotransferase, or total bilirubin values >1.2 × ULN.
• A known history of porphyria, myopathy, or active liver disease
• Use of any prescription medications
• Corticosteroid use (systemic or extensive topical use) within 3 months prior to dosing
• Subjects who have participated in more than 3 radiolabeled drug studies in the last 12 months

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.