Food Effect Study of HSK47388 in Healthy Subjects

Phase 1CompletedNCT07192692

Haisco Pharmaceutical Group Co., Ltd.15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pharmaceutical Preparations Health Adult Subjects

Interventions

fastDIETARY_SUPPLEMENT

fast state

low fat mealDIETARY_SUPPLEMENT

take HSK47388 with low fat meal

take meal after HSK47388 administrationDIETARY_SUPPLEMENT

take meal after HSK47388 administration at specific time

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects. 2. Adult males and females between ≥ 18 and ≤ 55 years (inclusive) at Screening. 3. Able and willing to attend the necessary visits to the study site Exclusion Criteria: 1. Participants with any disease history that may affect the safety evaluation or in vivo process of IP as judged by the PI or delegate, including central nervous, cardiovascular, digestive, respiratory, urinary, blood, immune and endocrine diseases. Participants with childhood asthma (resolved) can be included at the discretion of the PI. 2. Underlying physical or psychological medical condition that, in the opinion of the PI or delegate, would make the participant unlikely to comply with the protocol or complete the study per protocol. 3. Participants who may not be able to complete the study for other reasons, cannot comply with the requirements of the study, or are unsuitable to participate in the study as judged by the PI or delegate.

Locations (1)

The Sixth People's Hospital of Zhengzhou

Zhengzhou, Henan, China

Outcomes

Primary Outcomes

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

Time frame: 5 days after every period dose

Secondary Outcomes

pharmacokinetics of HSK47388

PK parameters: Cmax (Peak Plasma Concentration)

Time frame: time after 5 days in each period

pharmacokinetics of HSK47388

PK parameters:Area under the plasma concentration versus time curve (AUC)

Time frame: time after 5 days in each period

culmulative excretion rate

urine and feces culmulative excretion rate

Time frame: 5 days after dose in each period

Data from ClinicalTrials.gov

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