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

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05902728
• Other study ID #: HLX208-PK-001
• Status: Completed
• Phase: Phase 1
• Start date: July 4, 2023
• Est. completion date: December 19, 2023

Study information

• Verified date: April 2024
• Source: Shanghai Henlius Biotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 19, 2023
• Est. primary completion date: December 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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);

Related Conditions & MeSH terms

• NSCLC

Intervention

Drug:
• HLX208
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
• HLX208
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.
• HLX208
450 mg
• HLX208
900 mg
• Itraconazole 200 mg
200 mg
• Rifampicin
600mg

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Henlius Biotech

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics parameter Cmax of HLX208	Cmax of HLX208	up to 48 hours
Primary	Pharmacokinetics parameter AUC0-t of HLX208	AUC0-t of HLX208	up to 48 hours
Primary	Pharmacokinetics parameter AUC0-inf of HLX208	AUC0-inf of HLX208	up to 48 hours
Secondary	other pharmacokinetics parameter Tmax of HLX208	Tmax of HLX208	up to 48 hours
Secondary	other pharmacokinetics parameter Tlag of HLX208	Tlag of HLX208	up to 48 hours
Secondary	other pharmacokinetics parameter t1/2 of HLX208	t1/2 of HLX208	up to 48 hours
Secondary	other pharmacokinetics parameter CL/F of HLX208	CL/F of HLX208	up to 48 hours
Secondary	other pharmacokinetics parameter Vd/F of HLX208	Vd/F of HLX208	up to 48 hours
Secondary	other pharmacokinetics parameter MRT of HLX208	MRT of HLX208	up to 48 hours
Secondary	other pharmacokinetics parameter %AUCex of HLX208	%AUCex of HLX208	up to 48 hours
Secondary	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