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This is a Phase 1, single-dose, open-label, randomized, three-period, three-way crossover study in which healthy adult participants will receive three separate single-dose administrations of ASTX660 capsules under three different conditions.
Participants receiving Treatment A (fasting) will be dosed after having fasted overnight for at least 10 hours. Participants receiving Treatment B (fed; high-fat/high-calorie meal) will fast overnight for at least 10 hours then consume a Food and Drug Administration (FDA) standard high-fat, high-calorie breakfast beginning 30 minutes before dosing. Participants receiving Treatment C (fed; low-fat/low-calorie meal) will fast overnight for at least 10 hours then consume an FDA standard low-fat, low-calorie breakfast beginning 30 minutes before dosing. The duration of the study is expected to be approximately 47 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A - Fasting | Experimental | No food prior to dosing |
|
| Treatment B - Fed | Experimental | High-fat/high-calorie meal prior to dosing |
|
| Treatment C - Fed | Experimental | Low-fat/low-calorie meal prior to dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASTX660 | Drug | Form: capsule; Route of administration: oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter Cmax | Maximum plasma concentration | Predose to 72 hours postdose, up to Day 4 |
| Pharmacokinetic parameter Tmax | Time to reach maximum plasma concentration | Predose to 72 hours postdose, up to Day 4 |
| Pharmacokinetic parameter λz | Observed terminal rate constant | Predose to 72 hours postdose, up to Day 4 |
| Pharmacokinetic parameter t1/2 | Observed terminal half-life | Predose to 72 hours postdose, up to Day 4 |
| Pharmacokinetic parameter AUC(0-24h) | Area under the concentration-time curve from time-zero to 24 hours postdose | Predose to 24 hours postdose, up to Day 4 |
| Pharmacokinetic parameter AUClast | Area under the concentration-time curve from time-zero to the time of the last quantifiable concentration | Predose to 72 hours postdose, up to Day 4 |
| Pharmacokinetic parameter AUCinf | Area under the concentration-time curve from time-zero extrapolated to infinity | Predose to 72 hours postdose, up to Day 4 |
| Pharmacokinetic parameter AUCExtrap (%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Worldwide Clinical Trials | San Antonio | Texas | 78217 | United States |
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| ID | Term |
|---|---|
| C000710345 | ASTX-660 |
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Percentage of AUCinf based on extrapolation
| Predose to 72 hours postdose, up to Day 4 |
| Pharmacokinetic parameter Clast | Last quantifiable concentration determined directly from individual concentration-time data | Predose to 72 hours postdose, up to Day 4 |
| Pharmacokinetic parameter Tlast | Time of the last quantifiable concentration | Predose to 72 hours postdose, up to Day 4 |