301 FAQ

Question 1

How soon before randomization can serum K+ be collected

Answer 1

1-3days from local lab

Question 2

When and how should urinalysis be collected?

Answer 2

first morning, mid stream.
provided at screening and week 8 to allow for home collection on randomization and week 12

Question 3

What if cortisol isn’t drawn between 8-10am?

Answer 3

As close to 8am as possible

Question 4

If cortisol >35, how do you f/u?

Answer 4

24hr urinary free cortisol

Question 5

how is pregnancy screened?

Answer 5

serum pregnancy collected at screening. FSH to confirm post-menopausal status. uHCG at randomization, 4, 8, 12, 14 and confirmed with serum if positive

Question 6

When should investigator do unscheduled ACTH stim?

Answer 6

serum cortisol <3, or <10 and s/s of hypocortisolism

Question 7

What does IP work on

Answer 7

CYP11B2 (aldosterone synthase)

Question 8

What happens if a patient has an unscheduled dose adjustment?

Answer 8

another unscheduled visit to assess safety 2 weeks later

Question 9

strong CYP3a & CYP3A4 inducers prohibited during trial. Name some

Answer 9

(apalutamide, carbazmazepine, enzalutamide, fosphenytoin, lumacaftor, mitotane, phenobarbital, phenytoin, primidone, rifampin, St. John’s wart)

Question 10

Other meds prohibited in trial

Answer 10

ASIs
MRAs
corticosteroids (inhaled, intranasal, intraarticular, and intraspinal allowed)
sympathomimetic decongestants morning of BP assessment
routine short acting nitrates. (occasional use OK with monitoring). chronic nitrates OK
strong CYP3A(4)
PPI >3x a week