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Completed

NCT Number: NCT05902728

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

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.

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Key information

Conditions

NSCLC

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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);

Treatment and study plan

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

Itraconazole 200 mg

Drug

200 mg

rifampicin

Drug

600mg

Primary outcomes

  1. Pharmacokinetics parameter Cmax of HLX208

    Time frame: up to 48 hours

    Cmax of HLX208

  2. Pharmacokinetics parameter AUC0-t of HLX208

    Time frame: up to 48 hours

    AUC0-t of HLX208

  3. Pharmacokinetics parameter AUC0-inf of HLX208

    Time frame: up to 48 hours

    AUC0-inf of HLX208

Secondary outcomes

  1. other pharmacokinetics parameter Tmax of HLX208

    Time frame: up to 48 hours

    Tmax of HLX208

  2. other pharmacokinetics parameter Tlag of HLX208

    Time frame: up to 48 hours

    Tlag of HLX208

  3. other pharmacokinetics parameter t1/2 of HLX208

    Time frame: up to 48 hours

    t1/2 of HLX208

  4. other pharmacokinetics parameter CL/F of HLX208

    Time frame: up to 48 hours

    CL/F of HLX208

  5. other pharmacokinetics parameter Vd/F of HLX208

    Time frame: up to 48 hours

    Vd/F of HLX208

  6. other pharmacokinetics parameter MRT of HLX208

    Time frame: up to 48 hours

    MRT of HLX208

  7. other pharmacokinetics parameter %AUCex of HLX208

    Time frame: up to 48 hours

    %AUCex of HLX208

  8. The incidence and severity of adverse events/serious adverse events

    Time frame: up to 17 days after the last dose

    Occurrence of Serious Adverse Event (SAE), Adverse Event (AE)

Sponsors and collaborators

Lead sponsor

Shanghai Henlius Biotech

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 15, 2023
Registry last updated
Apr 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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