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This will be a Phase 1, open-label, randomized, 3-way crossover study to evaluate PK, safety, and tolerability of a new tablet formulation of CPI-444 and to evaluate the effect of food on single oral doses of CPI-444 tablets in healthy male and female subjects. Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the first dose administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence ABC | Active Comparator | 100 mg CPI-444, given orally as a 1 × 100-mg capsule, after an overnight fast of at least 10 hours (fasted); 100 mg CPI-444, given orally as a 1 × 100-mg tablet, after an overnight fast of at least 10 hours (fasted); 100 mg CPI-444, given orally as a 1 × 100-mg tablet, 30 minutes after the start of a high-fat breakfast (fed). |
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| Sequence BCA | Active Comparator | 100 mg CPI-444, given orally as a 1 × 100-mg tablet, after an overnight fast of at least 10 hours (fasted); 100 mg CPI-444, given orally as a 1 × 100-mg tablet, 30 minutes after the start of a high-fat breakfast (fed); 100 mg CPI-444, given orally as a 1 × 100-mg capsule, after an overnight fast of at least 10 hours (fasted). |
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| Sequence CAB | Active Comparator | 100 mg CPI-444, given orally as a 1 × 100-mg tablet, 30 minutes after the start of a high-fat breakfast (fed); 100 mg CPI-444, given orally as a 1 × 100-mg capsule, after an overnight fast of at least 10 hours (fasted); 100 mg CPI-444, given orally as a 1 × 100-mg tablet, after an overnight fast of at least 10 hours (fasted). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPI-444 Capsules | Drug | 100mg Capsule |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞: AUC from time zero to infinity | Area under the plasma concentration-time curve (AUC) from time zero to infinity | Predose through 72 hours postdose |
| AUC0-tz: AUC from time zero to last quantifiable concentration | AUC from time zero to the last quantifiable concentration | Predose through 72 hours postdose |
| %AUCex: Percentage of AUC0-∞ that was due to extrapolation from the last quantifiable concentration to infinity | Percentage of AUC0-∞ that was due to extrapolation from the last quantifiable concentration to infinity | Predose through 72 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit | Dallas | Texas | 75247 | United States |
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| ID | Term |
|---|---|
| C000633770 | ciforadenant |
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| CPI-444 Tablets | Drug | 100mg Tablets |
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