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

Phase 1

Completed

• Conditions: NSCLC
• Interventions: Drug: HLX208; Drug: Itraconazole 200 mg; Drug: Rifampicin

• Registration Number: NCT05902728
• Lead Sponsor: Shanghai Henlius Biotech

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-24
• Study First Submitted QC: 2023-06-05
• Study First Posted: 2023-06-15
• Study Start: 2023-07-04
• Primary Completion: 2023-12-19
• Study Completion: 2023-12-19
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. 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;
2. Male or female subjects aged 18 to 45 (including 18 and 45);
3. 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

1. Known history of drug or food allergy;
2. Those who have a positive urine drug screen or have a history of drug abuse;
3. Excessive smoking (≥ 5 cigarettes/day);

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HLX208 in the fed state	HLX208	HLX208 900mg in the fed state
HLX208 + Itraconazole group	HLX208	HLX208 + Itraconazole group
HLX208 in the fast state	HLX208	HLX208 900mg in the fast state
HLX208 + Itraconazole group	Itraconazole 200 mg	HLX208 + Itraconazole group
HLX208 + rifampicin group	HLX208	HLX208 + rifampicin group
HLX208 + rifampicin group	Rifampicin	HLX208 + rifampicin group

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics parameter AUC0-t of HLX208	up to 48 hours	AUC0-t of HLX208
Pharmacokinetics parameter Cmax of HLX208	up to 48 hours	Cmax of HLX208
Pharmacokinetics parameter AUC0-inf of HLX208	up to 48 hours	AUC0-inf of HLX208

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China