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

NCT ID: NCT05902728

Last Updated: 2024-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-04
• Study Completion Date: 2023-12-19

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.

Conditions

NSCLC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HLX208 in the fast state

HLX208 900mg in the fast state

Group Type: EXPERIMENTAL

HLX208

Intervention Type: DRUG

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 in the fed state

HLX208 900mg in the fed state

Group Type: EXPERIMENTAL

HLX208

Intervention Type: DRUG

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 + Itraconazole group

HLX208 + Itraconazole group

Group Type: EXPERIMENTAL

HLX208

Intervention Type: DRUG

450 mg

Itraconazole 200 mg

Intervention Type: DRUG

200 mg

HLX208 + rifampicin group

HLX208 + rifampicin group

Group Type: EXPERIMENTAL

HLX208

Intervention Type: DRUG

900 mg

Rifampicin

Intervention Type: DRUG

600mg

Interventions

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

Intervention Type: DRUG

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.

Intervention Type: DRUG

HLX208

450 mg

Intervention Type: DRUG

HLX208

900 mg

Intervention Type: DRUG

Itraconazole 200 mg

200 mg

Intervention Type: DRUG

Rifampicin

600mg

Intervention Type: DRUG

Eligibility Criteria

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);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Henlius Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Countries

China

Other Identifiers

HLX208-PK-001

Identifier Type: -

Identifier Source: org_study_id