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

Henlius Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: NSCLC

Treatments: Drug: HLX208; Drug: Rifampicin; Drug: Itraconazole 200 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05902728

HLX208-PK-001

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

HLX208 in the fast state

Experimental group

Description:

HLX208 900mg in the fast state

Treatment:

Drug: HLX208

Drug: HLX208

Drug: HLX208

Drug: HLX208

HLX208 in the fed state

Experimental group

Description:

HLX208 900mg in the fed state

Treatment:

Drug: HLX208

Drug: HLX208

Drug: HLX208

Drug: HLX208

HLX208 + Itraconazole group

Experimental group

Description:

HLX208 + Itraconazole group

Treatment:

Drug: HLX208

Drug: Itraconazole 200 mg

Drug: HLX208

Drug: HLX208

Drug: HLX208

HLX208 + rifampicin group

Experimental group

Description:

HLX208 + rifampicin group

Treatment:

Drug: HLX208

Drug: HLX208

Drug: HLX208

Drug: Rifampicin

Drug: HLX208