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This is a Phase 1, open-label, randomized, three-period crossover trial study to evaluate the effect of food and dosing and meal timing intervals on the pharmacokinetics (PK) of HSK46575 in healthy adult participants ,with an exploratory assessment of excretion pathways and excretion rates. Safety and tolerability will also be evaluated.
The study consists of 3 treatment sequences in a 3-period, crossover design. Approximately 15 healthy adult participants will be randomized 1:1:1 to one of the following sequences:
Sequence A: Participants will receive HSK47388 orally in the fasted state (condition 1), administrate HSK47388 immediately after low-fat meal (condition 2), administrate HSK47388 in the fasted state, followed by a standard meal speicific minutes later(condition 3).
Sequence B: Participants will receive administrate HSK47388 immediately after low-fat meal (condition 2), administrate HSK47388 in the fasted state, followed by a standard meal speicific minutes later(condition 3),HSK47388 orally in the fasted state (condition 1).
Sequence C: Participants will receive HSK47388 in the fasted state, followed by a standard meal speicific minutes later(condition 3),HSK47388 orally in the fasted state (condition 1), administrate HSK47388 immediately after low-fat meal (condition 2) .
All participants will remain under clinical observation for safety monitoring and pharmacokinetic sampling throughout each period. Blood, urine and fecal samples will be collected at defined intervals for the analysis of HSK47388 and its metabolites.
Each participant's total study duration will be approximately 37 days, including screening, treatment, and follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fast | Experimental | fast state |
|
| low fat meal | Experimental | take HSK47388 with low fat meal |
|
| take meal after HSK47388 administration | Experimental | take meal after HSK47388 administration at specific time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fast | Dietary Supplement | fast state |
| |
| low fat meal |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE | The incidence, severity, and relationship to IP of AEs. Change from Baseline in clinical laboratory parameters (ie, hematology, serum chemistry, coagulation, and urinalysis parameters), physical examination findings, vital signs | 5 days after every period dose |
| Measure | Description | Time Frame |
|---|---|---|
| pharmacokinetics of HSK47388 | PK parameters: Cmax (Peak Plasma Concentration) | time after 5 days in each period |
| pharmacokinetics of HSK47388 | PK parameters:Area under the plasma concentration versus time curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sixth People's Hospital of Zhengzhou | Zhengzhou | Henan | China |
for data confidence
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| Dietary Supplement |
take HSK47388 with low fat meal |
|
| take meal after HSK47388 administration | Dietary Supplement | take meal after HSK47388 administration at specific time |
|
| time after 5 days in each period |
| culmulative excretion rate | urine and feces culmulative excretion rate | 5 days after dose in each period |