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The primary objective of this study is to evaluate the pharmacokinetics (PK) of miricorilant in the presence and absence of the strong cytochrome P450 [(CYP) 2C19] inhibitor, fluvoxamine, in healthy participants. Participants will receive a single dose of miricorilant under fed conditions with a standard breakfast after an overnight fast alone and in combination with once-daily doses of fluvoxamine. Blood samples will be collected at regular intervals for PK and safety analysis between admission and discharge from the clinical unit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Miricorilant - Fluvoxamine/Miricorilant | Experimental | Participants will receive a single oral dose of miricorilant 600 mg on Days 1 and 10 and a single oral dose of fluvoxamine 50 mg on Days 4 to 12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Miricorilant | Drug | Miricorilant 6 x 100 mg coated tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration of miricorilant (Cmax) | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Days 1 and 10 | |
| Area under the curve from time zero to the time of last measurable plasma concentration of miricorilant (AUC0-last) | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Days 1 and 10 | |
| Area under the curve from time zero extrapolated to infinity of plasma concentration of miricorilant (AUC0-inf) | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Days 1 and 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with one or more treatment-emergent adverse events (TEAEs) | Up to 30 days after study drug administration | |
| Number of participants with one or more serious adverse events (SAEs) | Up to 30 days after study drug administration |
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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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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000606526 | CORT118335 |
| D016666 | Fluvoxamine |
| ID | Term |
|---|---|
| D010091 | Oximes |
| D006898 | Hydroxylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Fluvoxamine | Drug | Fluvoxamine 50 mg tablet |
|
| Number of participants with a clinically-significant vital sign abnormality | Up to Day 13 |
| Number of participants with a clinically-significant laboratory test abnormality | Up to Day 13 |