Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
Age
18–55
Sex
MALE
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Phase 1 Study to Determine the Metabolism and Clearance of Baxdrostat
