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This single-center, randomized, open-label study will assess the relative bioavailability of 2 miricorilant (CORT118335) tablet formulations.
This study will evaluate relative bioavailability of Kinetisol and spray dried dispersion (SDD) miricorilant (CORT118335) tablets. This study will consist of 6 possible treatment sequences across 3 periods for healthy, fed participants. A fourth period may be added to assess the impact of fasted conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Miricorilant Treatment Sequence A, B, C | Experimental | Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment A; in Period 2, treatment B; in Period 3, treatment C. A washout period of at least 7 days will follow each dose of the study drug. |
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| Miricorilant Treatment Sequence B, C, A | Experimental | Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment B, in Period 2, treatment C; in Period 3, treatment A. A washout period of at least 7 days will follow each dose of the study drug. |
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| Miricorilant Treatment Sequence C, A, B | Experimental | Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment C; in Period 2, treatment A; in Period 3, treatment B. A washout period of at least 7 days will follow each dose of the study drug. |
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| Miricorilant Treatment Sequence B, A, C | Experimental | Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment B; in Period 2, treatment A; in Period 3, treatment C. A washout period of at least 7 days will follow each dose of the study drug. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Miricorilant Treatment A | Drug | Miricorilant 100 mg (1 x 100 mg) Kinetisol immediate release (IR) tablet for oral administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Time of Maximum Observed Concentration (Tmax) of Miricorilant | Predose and at serial timepoints up to 72 hours postdose | |
| Maximum Observed Concentration (Cmax) of Miricorilant | Predose and at serial timepoints up to 72 hours postdose | |
| Concentration at 24 Hours Postdose (C24) of Miricorilant | Predose and at serial timepoints up to 24 hours postdose | |
| Area Under the Curve from Time 0 to the Time of Last Measurable Concentration (AUC[0-last]) of Miricorilant | Predose and at serial timepoints up to 72 hours postdose | |
| Area Under the Curve from Time 0 Extrapolated to Infinity (AUC[0-inf]) of Miricorilant | Predose and at serial timepoints up to 72 hours postdose | |
| Terminal Elimination Half-Life (T1/2) of Miricorilant | Predose and at serial timepoints up to 72 hours postdose | |
| Relative Bioavailability (Frel) for Miricorilant Based on Cmax | Predose and at serial timepoints up to 72 hours postdose | |
| Frel for Miricorilant based on AUC(0-last) | Predose and at serial timepoints up to 72 hours postdose | |
| Frel for Miricorilant Based on AUC(0-inf) | Predose and at serial timepoints up to 72 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Abnormal, Clinically Significant Clinical Laboratory Findings | Clinical laboratory findings include hematology, clinical chemistry, urinalysis. | Day -1 and 72 hours postdose in periods 3 and 4 |
| Number of Participants with Abnormal, Clinically Significant 12-Lead Electrocardiogram (ECG) Findings |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Custodio, PhD | Corcept Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 01 | Miami | Florida | 33126 | United States |
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| Miricorilant Treatment Sequence A, C, B | Experimental | Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment A; in Period 2, treatment C; in Period 3, treatment B. A washout period of at least 7 days will follow each dose of the study drug. |
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| Miricorilant Treatment Sequence C, B, A | Experimental | Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment C; in Period 2, treatment B; in Period 3, treatment A. A washout period of at least 7 days will follow each dose of the study drug. |
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| Optional Miricorilant Treatment D | Experimental | After completion of Period 3, analysis of pharmacokinetic and safety data will be used to decide if Period 4 will be conducted. In Period 4, selected participants will receive a single dose of treatment D in a fasted state on Day 1. |
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| Miricorilant Treatment B | Drug | Miricorilant 100 mg (2 x 50 mg) Kinetisol IR tablet for oral administration |
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| Miricorilant Treatment C | Drug | Miricorilant 100 mg (2 x 50 mg) SDD IR tablet for oral administration |
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| Miricorilant Treatment D | Drug | Miricorilant 100 mg (1 x 100 mg or 2 x 50 mg) Kinetisol IR tablet for oral administration. The tablet strength administered will be decided after Period 3 is complete. |
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| Day -1, predose, and at 4 and 72 hours postdose in every study period |
| Number of Participants with Abnormal, Clinically Significant Vital Sign Findings | Day -1, predose, and at serial time points up to 72 hours postdose in every study period |
| Number of Participants with Abnormal, Clinically Significant Physical Exam Findings | 72 hours postdose in periods 3 and 4 |
| Number of Participants with 1 or More Adverse Events | Screening up to 30 days postdose |
| ID | Term |
|---|---|
| C000606526 | CORT118335 |
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