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

NCT05902728 | Completed Phase 1

• 1 other identifier: HLX208-PK-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• other pharmacokinetics parameter Tmax of HLX208

  up to 48 hours

• other pharmacokinetics parameter Tlag of HLX208

  up to 48 hours

• other pharmacokinetics parameter t1/2 of HLX208

  up to 48 hours

• other pharmacokinetics parameter CL/F of HLX208

  up to 48 hours

• other pharmacokinetics parameter Vd/F of HLX208

  up to 48 hours

Study Arms (4)

HLX208 in the fast state

EXPERIMENTAL

HLX208 900mg in the fast state

Drug: HLX208

HLX208 in the fed state

EXPERIMENTAL

HLX208 900mg in the fed state

Drug: HLX208

HLX208 + Itraconazole group

EXPERIMENTAL

HLX208 + Itraconazole group

Drug: HLX208; Drug: Itraconazole 200 mg

HLX208 + rifampicin group

EXPERIMENTAL

HLX208 + rifampicin group

Drug: HLX208; Drug: Rifampicin

Interventions

HLX208 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 fast state

Itraconazole 200 mg DRUG

200 mg

HLX208 + Itraconazole group

Rifampicin DRUG

600mg

HLX208 + rifampicin group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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);

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

MeSH Terms

Interventions

Itraconazole; Rifampin

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 15, 2023
• Study Start: July 4, 2023
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)