NSCLC
Conditions
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.
Interventions
DRUGHLX208
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
200 mg
DRUGRifampicin
600mg
Sponsors
Shanghai Henlius Biotech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics parameter Cmax of HLX208 | up to 48 hours | Cmax of HLX208 |
| Pharmacokinetics parameter AUC0-t of HLX208 | up to 48 hours | AUC0-t of HLX208 |
| Pharmacokinetics parameter AUC0-inf of HLX208 | up to 48 hours | AUC0-inf of HLX208 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| other pharmacokinetics parameter CL/F of HLX208 | up to 48 hours | CL/F of HLX208 |
| other pharmacokinetics parameter Vd/F of HLX208 | up to 48 hours | Vd/F of HLX208 |
| other pharmacokinetics parameter Tmax of HLX208 | up to 48 hours | Tmax of HLX208 |
| other pharmacokinetics parameter %AUCex of HLX208 | up to 48 hours | %AUCex of HLX208 |
| The incidence and severity of adverse events/serious adverse events | up to 17 days after the last dose | Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) |
| other pharmacokinetics parameter MRT of HLX208 | up to 48 hours | MRT of HLX208 |
| other pharmacokinetics parameter Tlag of HLX208 | up to 48 hours | Tlag of HLX208 |
| other pharmacokinetics parameter t1/2 of HLX208 | up to 48 hours | t1/2 of HLX208 |
Countries
China
Outcome results
None listed