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This dedicated T/QT study will investigate the effect of relacorilant on cardiac repolarization in healthy participants.
This four-period crossover study with 12 treatment sequences includes relacorilant administered at therapeutic (400 mg once daily [QD]) and supra-therapeutic (800 mg QD) doses, placebo for relacorilant as a negative control, and oral moxifloxacin as a positive control. The positive control will serve to determine the sensitivity of the assay to detect small increases from baseline in the QTc interval. Each of the four treatment periods will last 5 days with a washout of at least 10 days between periods. Relacorilant and placebo to relacorilant will be administered double-blind; moxifloxacin will be administered open label.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1 | Experimental | Participants will receive relacorilant 400 mg once daily (QD) for 5 days in Period 1, followed by relacorilant 800 mg QD for 5 days in Period 2, followed by placebo to relacorilant QD for 5 days in Period 3, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 4. Treatment periods will be separated by a washout of at least 10 days. |
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| Treatment Sequence 2 | Experimental | Participants will receive relacorilant 800 mg QD for 5 days in Period 1, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 2, followed by relacorilant 400 mg QD for 5 days in Period 3, followed by placebo to relacorilant QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days. |
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| Treatment Sequence 3 | Experimental | Participants will receive placebo to relacorilant QD for 5 days in Period 1, followed by relacorilant 400 mg QD for 5 days in Period 2, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 3, followed by relacorilant 800 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days. |
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| Treatment Sequence 4 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relacorilant | Drug | Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Placebo-corrected Change from Baseline in Cardiac QT Interval Corrected by Fridericia's Formula (QTcF) | Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Cardiac QTcF | Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period | |
| Change from Baseline in Heart Rate (HR) | Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period |
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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 |
|---|---|---|---|---|---|---|
| Single Site | Springfield | Missouri | 65802 | United States |
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| ID | Term |
|---|---|
| C000633444 | relacorilant |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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Participants will receive relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 1, followed by placebo to relacorilant QD for 5 days in Period 2, followed by relacorilant 800 mg QD for 5 days in Period 3, followed by relacorilant 400 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
| Treatment Sequence 5 | Experimental | Participants will receive relacorilant 800 mg QD for 5 days in Period 1, followed by placebo to relacorilant QD for 5 days in Period 2, followed by relacorilant 400 mg QD for 5 days in Period 3, followed by relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 4. Treatment periods will be separated by a washout of at least 10 days. |
|
| Treatment Sequence 6 | Experimental | Participants will receive placebo to relacorilant QD for 5 days in Period 1, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 2, followed by relacorilant 800 mg QD for 5 days in Period 3, followed by relacorilant 400 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days. |
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| Treatment Sequence 7 | Experimental | Participants will receive relacorilant 400 mg QD for 5 days in Period 1, followed by relacorilant 800 mg QD for 5 days in Period 2, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 3, followed by placebo to relacorilant QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days. |
|
| Treatment Sequence 8 | Experimental | Participants will receive placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 1, followed by relacorilant 400 mg QD for 5 days in Period 2, followed by placebo to relacorilant QD for 5 days in Period 3, followed by relacorilant 800 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days. |
|
| Treatment Sequence 9 | Experimental | Participants will receive placebo to relacorilant QD for 5 days in Period 1, followed by relacorilant 400 mg QD for 5 days in Period 2, followed by relacorilant 800 mg QD for 5 days in Period 3, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 4. Treatment periods will be separated by a washout of at least 10 days. |
|
| Treatment Sequence 10 | Experimental | Participants will receive relacorilant 400 mg QD for 5 days in Period 1, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 2, followed by placebo to relacorilant QD for 5 days in Period 3, followed by relacorilant 800 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days. |
|
| Treatment Sequence 11 | Experimental | Participants will receive relacorilant 800 mg QD for 5 days in Period 1, followed by placebo to relacorilant QD for 5 days in Period 2, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 3, followed by relacorilant 400 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days. |
|
| Treatment Sequence 12 | Experimental | Participants will receive placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 1, followed by relacorilant 800 mg QD for 5 days in Period 2, followed by relacorilant 400 mg QD for 5 days in Period 3, followed by placebo to relacorilant QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days. |
|
|
| Placebo to relacorilant | Drug | Placebo to relacorilant capsule by mouth once daily |
|
| Moxifloxacin | Drug | Moxifloxacin 400 mg tablet by mouth |
|
| Placebo-corrected Change from Baseline in HR | Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period |
| Change from Baseline in Cardiac PR Interval | Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period |
| Placebo-corrected Change from Baseline in Cardiac PR Interval | Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period |
| Change from Baseline in Cardiac QRS Intervals | Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period |
| Placebo-corrected Change from Baseline in Cardiac QRS Intervals | Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period |
| Number of Participants with a Categorical Outlier in QTcF | Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period) |
| Number of Participants with a Categorical Outlier in HR | Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period) |
| Number of Participants with a Categorical Outlier in PR Interval | Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period) |
| Number of Participants with a Categorical Outlier in QRS Intervals | Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period) |
| Number of Participants with a Treatment-emergent Change of T-wave Morphology | Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period) |
| Number of Participants with a Treatment-emergent Presence of U-waves | Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period) |
| Maximum Plasma Concentration (Cmax) of Relacorilant, Metabolites of Relacorilant, and Moxifloxacin | Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period |
| Time to Reach Cmax (Tmax) of Plasma Relacorilant, Metabolites of Relacorilant, and Moxifloxacin | Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period |
| Minimum Plasma Concentration (Cmin) of Relacorilant, Metabolites of Relacorilant, and Moxifloxacin | Before dosing on Day 5 of each treatment period |
| Area Under the Plasma-concentration Curve from Time Zero to Time of Last Measurable Concentration (AUClast) of Relacorilant, Metabolites of Relacorilant, and Moxifloxacin | Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period |
| Area Under the Plasma-concentration Curve from Time Zero to 24 Hours Postdose (AUC0-24) of Relacorilant, Metabolites of Relacorilant, and Moxifloxacin | Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period |
| Number of Participants with One or More Adverse Events | Up to Day 6 in each treatment period (up to 51 days) |
| Number of Participants Discontinued From Study Treatment due to an Adverse Event | Up to Day 6 of each treatment period (up to 51 days) |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |