This study aims to evaluate the impact of strong CYP3A4 induction on the pharmacokinetics (PK) of atumelnant, as well as the effect of atumelnant on CYP3A4, P-gp, and MATE1/2-K substrates in healthy participants.
This is a Phase 1, open-label, two-Cohort Study to assess the effect of a strong CYP3A4 inducer on the pharmacokinetics of atumelnant and the effect of atumelnant on the pharmacokinetics of CYP3A4, P-gp, and MATE1/2-K Substrates in healthy participants. Approximately 20 healthy male and female participants adult male and female (of non-childbearing potential) participants will be enrolled in Cohort 1. Approximately 26 healthy male and female participants adult male and female (of non-childbearing potential) participants will be enrolled in Cohort 2.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Crinetics Study Site
Lincoln, Nebraska, United States
Cohort 1: Pharmacokinetics (AUC 0-last)
Time frame: Up to Day 34
Cohort 1: Pharmacokinetics (AUC 0-inf)
Time frame: Up to Day 34
Cohort 1: Pharmacokinetics (Cmax)
Time frame: Up to Day 34
Cohort 2: Pharmacokinetics (AUC 0-last)
Time frame: Up to Day 21
Cohort 2: Pharmacokinetics (AUC 0-inf)
Time frame: Up to Day 21
Cohort 2: Pharmacokinetics (Cmax)
Time frame: Up to Day 21
Cohort 1: Number of participants with Treatment Emergent Adverse Events
Time frame: Up to Day 34
Cohort 2: Number of participants with Treatment Emergent Adverse Events
Time frame: Up to Day 21
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
P-gp substrate
MATE1/2-K substrate