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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004655-36 | EudraCT Number |
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This study will assess the safety, tolerability, and pharmacokinetics (PK) of miricorilant (CORT118335) tablet formulations following single and multiple oral administration in healthy participants.
Cohort 1 will evaluate safety, tolerability, and PK of single doses of a 150-mg and a new 300-mg tablet formulation of miricorilant. Cohort 1 treatment will be randomized and open label.
Optional Cohorts 2 and 3 will evaluate single- and repeated-dose administration of miricorilant using a formulation, dose, and dose-regimen determined after interim evaluation of PK and safety data from previous cohorts. Cohort 2 and 3 treatments will be randomized, blinded, and placebo controlled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Miricorilant 900 mg (Regimen A1) | Experimental | Participants will receive a single oral dose of miricorilant 900 mg (3 X 300 mg) after breakfast on Day 1. Cohort 1 treatment will be randomized and open label. |
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| Cohort 1: Miricorilant 300 mg (Regimen A2) | Experimental | Participants will receive a single oral dose of miricorilant 300 mg (2 X 150 mg) after breakfast on Day 1. Cohort 1 treatment will be randomized and open label. |
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| Cohort 2: Miricorilant (Regimen B1 and B2) | Experimental | Participants will receive a single oral dose of miricorilant 900 mg (6 X 150 mg) after breakfast on Day 1 (Regimen B1). After a minimum 7-day washout, participants will receive miricorilant 900 mg (6 X 150 mg) qd for 14 days (Regimen B2). Day 1 treatment in Regimen B2 will be in the fasted state; the remaining doses will follow breakfast. Cohort 2 treatments will be randomized and blinded. |
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| Cohort 2: Placebo (Regimen B1 and B2) | Placebo Comparator | Participants will receive a single oral dose of placebo matching miricorilant 900 mg (6 X 150 mg) after breakfast on Day 1 (Regimen B1). After a minimum 7-day washout, participants will receive placebo matching miricorilant 900 mg (6 X 150 mg) qd for 14 days (Regimen B2). Day 1 treatment in Regimen B2 will be in the fasted state; the remaining doses will follow breakfast. Cohort 2 treatments will be randomized and blinded. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Miricorilant 300 mg tablets | Drug | Miricorilant 300 mg tablets for oral administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with One or More Adverse Events | Up to 7±2 days after the last dose (up to approximately Day 9 for Cohort 1 and up to approximately Day 23 for Cohorts 2 and 3) | |
| Percentage of Participants with One or More Serious Adverse Events | Up to 7±2 days after the last dose (up to approximately Day 9 for Cohort 1 and up to approximately Day 23 for Cohorts 2 and 3) | |
| Percentage of Participants Discontinued from the Study due to an Adverse Event | Up to 7±2 days after the last dose (up to approximately Day 9 for Cohort 1 and up to approximately Day 23 for Cohorts 2 and 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Pharmacokinetics (PK) of Miricorilant: Elapsed Time from Dosing at which the Analyte was First Quantifiable in a Concentration vs Time Profile (tlag) | Single-dose regimens: before dosing and at pre-specified time points up to 72 hours after dosing (Day 4) | |
| Plasma PK of Miricorilant: Maximum Observed Concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharan Sidhu, MBChB, BAO, MRCS, MFPM | Quotient Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences | Ruddington | Nottingham | NG11 6JS | United Kingdom |
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| ID | Term |
|---|---|
| C000606526 | CORT118335 |
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| Cohort 3: Miricorilant (Regimen C1 and C2) | Experimental | Participants will receive two oral doses (morning and evening) of miricorilant 1350 mg (9 X 150 mg) after a meal on Day 1 (Regimen C1). After a minimum 7-day washout, participants will receive miricorilant 750 mg (5 X 150 mg) after breakfast for 14 days and miricorilant 600 mg (4 X 150 mg) in the evening after a meal for 13 days (Regimen C2). Cohort 3 treatments will be randomized and blinded. |
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| Cohort 3: Placebo (Regimen C1 and C2) | Placebo Comparator | Participants will receive two oral doses (morning and evening) of placebo matching miricorilant 1350 mg (9 X 150 mg) after a meal on Day 1 (Regimen C1). After a minimum 7-day washout, participants will receive placebo matching miricorilant 750 mg (5 X 150 mg) after breakfast for 14 days and placebo matching miricorilant 600 mg (4 X 150 mg) in the evening after a meal for 13 days (Regimen C2). Cohort 3 treatments will be randomized and blinded. |
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| Miricorilant 150 mg tablets | Drug | Miricorilant 150 mg tablets for oral administration |
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| Placebo 150 mg tablets | Drug | Placebo to match miricorilant 150 mg tablets for oral administration |
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| Single-dose regimens: before dosing and at pre-specified time points up to 72 hours after dosing (Day 4); Repeated-dose regimens: before dosing and at pre-specified time points up to 72 hours after final dose (Day 17) |
| Plasma PK of Miricorilant: Time from Dosing at which Cmax was Apparent (Tmax) | Single-dose regimens: before dosing and at pre-specified time points up to 72 hours after dosing (Day 4); Repeated-dose regimens: before dosing and at pre-specified time points up to 72 hours after final dose (Day 17) |
| Plasma PK of Miricorilant: Apparent Elimination Half-life (t1/2) | Single-dose regimens: before dosing and at pre-specified time points up to 72 hours after dosing (Day 4); Repeated-dose regimens: before dosing and at pre-specified time points up to 72 hours after final dose (Day 17) |
| Plasma PK of Miricorilant: Area Under the Curve from Time Zero to the Last Measurable Concentration (AUC0-last) | Single-dose regimens: before dosing and at pre-specified time points up to 72 hours after dosing (Day 4) |
| Plasma PK of Miricorilant: Area Under the Curve from Time Zero to 24 Hours Postdose (AUC0-24) | Repeated-dose regimens: before dosing and at pre-specified time points up to 72 hours after final dose (Day 17) |