The purpose of this study is to assess the PK profile, safety, and tolerability of atumelnant after single and multiple once daily (QD) oral doses in healthy Japanese and Caucasian adult participants.
This is a Phase 1, stratified randomized, double-blind, placebo-controlled, 2-cohort, 2-period, fixed-sequence study to assess the PK profile, safety, and tolerability of atumelnant after single and multiple QD oral doses in healthy Japanese and Caucasian adult participants. Approximately 20 healthy male and female participants of either Japanese or Caucasian ethnicities will be enrolled in the study to receive the study intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
21
Atumelnant, tablets, once daily by mouth
Placebo, tablets, once daily by mouth
Crinetics Study Site
Glendale, California, United States
Pharmacokinetics (Cmax)
Assessment of the maximum observed plasma concentration of atumelnant
Time frame: [Time Frame: Up to Day 30]
Pharmacokinetics (Tmax)
Assessment of time to maximal atumelnant concentration (Tmax)
Time frame: [Time Frame: Up to Day 30]
Pharmacokinetics (AUC)
Assessment of the plasma area under the curve of Atumelnant
Time frame: [Time Frame: Up to Day 30]
Number of participants with Treatment Emergent Adverse Events including Adverse Events of Special Interest (adrenal insufficiency)
Time frame: [Time Frame: Up to Day 50]
Number of participants with clinically significant clinical laboratory abnormalities
Time frame: [Time Frame: Up to Day 30]
Number of participants with clinically significant changes in vital signs
Time frame: [Time Frame: Up to Day 30]
Number of participants with clinically significant changes in physical exam observations
Time frame: [Time Frame: Up to Day 30]
Number of participants with clinically significant Electrocardiogram (ECG) abnormalities
Time frame: [Time Frame: Up to Day 20]
12-lead triplicate Electrocardiogram (ECG) corrected QT interval (QTc) interval
Time frame: [Time Frame: Up to Day 20]
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