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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (Cohort 1) | Experimental | Fixed-sequence cohort for Japanese participants. |
|
| Placebo (Cohort 1) | Active Comparator | Fixed-sequence cohort for Japanese participants. |
|
| Treatment (Cohort 2) | Experimental | Fixed-sequence cohort for Caucasian participants. |
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| Placebo (Cohort 2) | Active Comparator | Fixed-sequence cohort for Caucasian participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atumelnant | Drug | Atumelnant, tablets, once daily by mouth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (Cmax) | Assessment of the maximum observed plasma concentration of atumelnant | [Time Frame: Up to Day 30] |
| Pharmacokinetics (Tmax) | Assessment of time to maximal atumelnant concentration (Tmax) | [Time Frame: Up to Day 30] |
| Pharmacokinetics (AUC) | Assessment of the plasma area under the curve of Atumelnant | [Time Frame: Up to Day 30] |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Treatment Emergent Adverse Events including Adverse Events of Special Interest (adrenal insufficiency) | [Time Frame: Up to Day 50] | |
| Number of participants with clinically significant clinical laboratory abnormalities | [Time Frame: Up to Day 30] |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Crinetics Study Site | Glendale | California | 91206 | United States |
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| Placebo | Drug | Placebo, tablets, once daily by mouth |
|
| Number of participants with clinically significant changes in vital signs | [Time Frame: Up to Day 30] |
| Number of participants with clinically significant changes in physical exam observations | [Time Frame: Up to Day 30] |
| Number of participants with clinically significant Electrocardiogram (ECG) abnormalities | [Time Frame: Up to Day 20] |
| 12-lead triplicate Electrocardiogram (ECG) corrected QT interval (QTc) interval | [Time Frame: Up to Day 20] |