Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Mineralys Therapeutics Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Male and nonpregnant, nonlactating female subjects ≥ 18 years of age.
2. Written informed consent Health Insurance Portability and Accountability Act authorization, and local patient privacy required documentation for this study have been obtained
3. Automated office blood pressure (AOBP) with SBP ≥ 130 mm Hg
4. Background antihypertensive treatment of ≥ 2 drugs
5. Serum cortisol ≥ 18 mcg/dL
You may not be if
1\. Concomitant use of epithelial sodium channel inhibitors or mineralocorticoid receptor antagonists
3\. Subjects with hypokalemia
4\. Subjects with hyperkalemia
5\. Subjects with serum cortisol \< 3 mcg/dL
6\. Subjects with serum sodium \< 135 mEq/L
7\. Subjects with estimated glomerular filtration rate \< 60 mL/min/1.73m2
8\. Subjects with type 1 or uncontrolled (hemoglobin A1c ≥ 9%) type 2 diabetes mellitus
9\. Subjects with body mass index \> 40 kg/m2
10\. Subjects with unstable angina
11\. Subjects with SBP ≥ 175 mm Hg or DBP ≥ 100 mm Hg for Part 1 and SBP ≥ 160 mm Hg or DBP ≥ 100 mm Hg for Part 2 at Pre-Screening, Screening/Start of Placebo Run-in, or Randomization
12\. Subjects with a decrease in SBP ≥ 20 mm Hg or DBP ≥ 10 mm Hg from sitting to standing position at screening
13\. Subjects who, in the opinion of the investigator, have suspected nonadherence to antihypertensive treatment
14\. Subjects who, in the opinion of the investigator, have any major medical illness or symptoms
15\. Subjects who, in the opinion of the investigator, have any acute or chronic medical or psychiatric condition
16\. Subjects undergoing treatment with any of the following medications:
1. Topical corticoids
2. Sympathomimetic decongestants
3. Theophylline
4. Phosphodiesterase type 5 inhibitors
5. NSAIDs
6. Intramuscular steroids
7. Estrogen
8. Cytochromes
9. Strong CYP3A and CYP3A4 inducers
17\. Subjects with known hypersensitivity to MLS-101 or any of the excipients
