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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000633-39 | EudraCT Number |
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This study will investigate if there is any difference in the amount of weight gained by participants taking olanzapine with CORT118335 compared with olanzapine with placebo (a dummy test medicine which looks like CORT118335 but contains no active medicine). Safety and tolerability of CORT118335 when taken with olanzapine will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olanzapine plus CORT118335 | Experimental | Participants will receive olanzapine 10 mg oral tablets and double-blind CORT118335 600 mg after breakfast once daily for 14 days. |
|
| Olanzapine plus Placebo | Placebo Comparator | Participants will receive olanzapine 10 mg oral tablets and double-blind placebo matching CORT118335 oral tablets after breakfast once daily for 14 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olanzapine | Drug | Olanzapine 10 mg oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline in Body Weight | Pre-dose on Day 1 (Baseline) and Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with One or More Adverse Events | Up to Day 28 | |
| Percentage of Participants with One or More Serious Adverse Events | Up to Day 28 | |
| Percentage of Participants Discontinued from the Study due to an Adverse Event |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
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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 |
|---|---|
| D000077152 | Olanzapine |
| C000606526 | CORT118335 |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| CORT118335 | Drug | CORT118335 600 mg oral tablets administered as 2 X 300 mg or 6 X 100 mg tablets |
|
| Placebo | Drug | Placebo matching CORT118335, 2 or 6 oral tablets, depending on the CORT118335 tablet strength available |
|
| Up to Day 28 |
| Mean Change from Baseline in Glucose | Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28 |
| Mean Change from Baseline in Insulin | Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28 |
| Mean Change from Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28 |
| Mean Change from Baseline in Triglycerides | Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28 |
| Mean Change from Baseline in Waist-to-Hip Ratio | Pre-dose on Day 1 (Baseline), Days 8, 15, and 28 |
| Plasma Pharmacokinetics (PK) of CORT118335: Time from Dosing at which Maximum Concentration is Apparent (tmax) | Pre-dose and at pre-specified time points up to 24 hours after dosing on Day 7 |
| Plasma PK of CORT118335: Maximum Observed Concentration (Cmax) | Pre-dose and at pre-specified time points up to 24 hours after dosing on Day 7 |
| Plasma PK of CORT118335: Area Under the Concentration-Time Curve Over the Dose Interval (AUCtau) | Pre-dose and at pre-specified time points up to 24 hours after dosing on Day 7 |
| D006571 | Heterocyclic Compounds |