Study on Food Influence and Drug-drug Interaction of HLX208 Tablets in Chinese Healthy Subjects

Study Overview
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Brief Summary
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This study is divided into Part I and Part II. Part I is the food effect study. A total of 20 healthy subjects, regardless of gender, will be enrolled in a randomized, open-label, crossover design. Part II is the drug-drug interaction study, an open-label and sequential design. 32 healthy subjects are planned to be enrolled and divided into group A and group B. Group A is to evaluate the influence of itraconazole as CYP3A4 strong inhibitory on HLX208. Group B was to evaluate the effect of rifampicin as a strong inducer of CYP3A4 on HLX208.

Official Title
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Study on Food Influence and Drug-drug Interaction of HLX208 Tablets in Chinese Healthy Subjects

Conditions
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NSCLC

Intervention / Treatment
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* Drug: HLX208
* Drug: HLX208
* Drug: HLX208
* Drug: HLX208
* Drug: Itraconazole 200 mg
* Drug: Rifampicin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign the informed consent before the trial, and fully understand the content, process and possible adverse reactions of the trial. Must be able to communicate with the investigator, understand and comply with all study requirements; Male or female subjects aged 18 to 45 (including 18 and 45); Weigh at least 50 kg (for male) and 45 kg (for female), respectively, and have a body mass index (BMI) ≥ 19 and ≤26 kg/m2. BMI = weight (kg)/[height (m)]2; Exclusion Criteria: Known history of drug or food allergy; Those who have a positive urine drug screen or have a history of drug abuse; Excessive smoking (≥ 5 cigarettes/day);

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HLX208 in the fast state<br>HLX208 900mg in the fast state | Drug: HLX208<br>* Subjects will receive treatment HLX208 900 mg in the fast state followed by 7 days washout ，then receive treatment HLX208 900 mg in the fed state<br>|
| Experimental: HLX208 in the fed state<br>HLX208 900mg in the fed state | Drug: HLX208<br>* Subjects will receive treatment HLX208 900 mg in the fed state followed by 7 days washout ，then receive treatment HLX208 900 mg in the fast state.<br>|
| Experimental: HLX208 + Itraconazole group<br>HLX208 + Itraconazole group | Drug: HLX208<br>* 450 mg<br>Drug: Itraconazole 200 mg<br>* 200 mg<br>|
| Experimental: HLX208 + rifampicin group<br>HLX208 + rifampicin group | Drug: HLX208<br>* 900 mg<br>Drug: Rifampicin<br>* 600mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics parameter Cmax of HLX208 | Cmax of HLX208 | up to 48 hours | 
| Pharmacokinetics parameter AUC0-t of HLX208 | AUC0-t of HLX208 | up to 48 hours | 
| Pharmacokinetics parameter AUC0-inf of HLX208 | AUC0-inf of HLX208 | up to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| other pharmacokinetics parameter Tmax of HLX208 | Tmax of HLX208 | up to 48 hours | 
| other pharmacokinetics parameter Tlag of HLX208 | Tlag of HLX208 | up to 48 hours | 
| other pharmacokinetics parameter t1/2 of HLX208 | t1/2 of HLX208 | up to 48 hours | 
| other pharmacokinetics parameter CL/F of HLX208 | CL/F of HLX208 | up to 48 hours | 
| other pharmacokinetics parameter Vd/F of HLX208 | Vd/F of HLX208 | up to 48 hours | 
| other pharmacokinetics parameter MRT of HLX208 | MRT of HLX208 | up to 48 hours | 
| other pharmacokinetics parameter %AUCex of HLX208 | %AUCex of HLX208 | up to 48 hours | 
| The incidence and severity of adverse events/serious adverse events | Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) | up to 17 days after the last dose |