NSCLCPhase 1NCT05902728
Study on Food Influence and Drug-drug Interaction of HLX208 Tablets in Chinese Healthy Subjects
A Phase 1 study testing HLX208, Itraconazole 200 mg and Rifampicin in people with NSCLC, run by Shanghai Henlius Biotech at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- NSCLC
- What is being tested?
- HLX208, Itraconazole 200 mg and Rifampicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2023to 19 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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);
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- HLX208, Itraconazole 200 mg, Rifampicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX208Drug
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
HLX208Drug
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.
HLX208Drug
450 mg
HLX208Drug
900 mg
Itraconazole 200 mgDrug
200 mg
RifampicinDrug
600mg
| Study group | Role | What they receive |
|---|---|---|
| HLX208 in the fast state | Experimental | HLX208 900mg in the fast state Receives: Drug: HLX208 |
| HLX208 in the fed state | Experimental | HLX208 900mg in the fed state Receives: Drug: HLX208 |
| HLX208 + Itraconazole group | Experimental | HLX208 + Itraconazole group Receives: Drug: HLX208; Drug: Itraconazole 200 mg |
| HLX208 + rifampicin group | Experimental | HLX208 + rifampicin group Receives: Drug: HLX208; Drug: Rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics parameter Cmax of HLX208
Cmax of HLX208
Measured: up to 48 hours
Pharmacokinetics parameter AUC0-t of HLX208
AUC0-t of HLX208
Measured: up to 48 hours
Pharmacokinetics parameter AUC0-inf of HLX208
AUC0-inf of HLX208
Measured: up to 48 hours
Secondary outcomes (8)
other pharmacokinetics parameter Tmax of HLX208
Tmax of HLX208
Measured: up to 48 hours
other pharmacokinetics parameter Tlag of HLX208
Tlag of HLX208
Measured: up to 48 hours
other pharmacokinetics parameter t1/2 of HLX208
t1/2 of HLX208
Measured: up to 48 hours
other pharmacokinetics parameter CL/F of HLX208
CL/F of HLX208
Measured: up to 48 hours
other pharmacokinetics parameter Vd/F of HLX208
Vd/F of HLX208
Measured: up to 48 hours
other pharmacokinetics parameter MRT of HLX208
MRT of HLX208
Measured: up to 48 hours
other pharmacokinetics parameter %AUCex of HLX208
%AUCex of HLX208
Measured: up to 48 hours
The incidence and severity of adverse events/serious adverse events
Occurrence of Serious Adverse Event (SAE), Adverse Event (AE)
Measured: up to 17 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start4 Jul 2023
- Primary completion19 Dec 2023
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902728
- Sponsor's protocol ID
- HLX208-PK-001
- Status last verified
- Apr 2024
- First submitted
- 24 May 2023
- Last updated
- 5 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Food Influence and Drug-drug Interaction of HLX208 Tablets in Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT05902728
- Acronym / sponsor ID
- HLX208-PK-001
- Conditions
- NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HLX208 in the fast state | Experimental | Drug: HLX208HLX208 900mg in the fast state |
| HLX208 in the fed state | Experimental | Drug: HLX208HLX208 900mg in the fed state |
| HLX208 + Itraconazole group | Experimental | Drug: HLX208, Drug: Itraconazole 200 mgHLX208 + Itraconazole group |
| HLX208 + rifampicin group | Experimental | Drug: HLX208, Drug: RifampicinHLX208 + rifampicin group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (3 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLX208Subjects 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 | Drug | HLX208 in the fast state |
| HLX208Subjects 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. | Drug | HLX208 in the fed state |
| HLX208450 mg | Drug | HLX208 + Itraconazole group |
| HLX208900 mg | Drug | HLX208 + rifampicin group |
| Itraconazole 200 mg200 mg | Drug | HLX208 + Itraconazole group |
| Rifampicin600mg | Drug | HLX208 + rifampicin group |
Primary outcome
Pharmacokinetics parameter Cmax of HLX208
Time frame: up to 48 hours
Cmax of HLX208
Pharmacokinetics parameter AUC0-t of HLX208
Time frame: up to 48 hours
AUC0-t of HLX208
Pharmacokinetics parameter AUC0-inf of HLX208
Time frame: up to 48 hours
AUC0-inf of HLX208
8 secondary outcomes
other pharmacokinetics parameter Tmax of HLX208
Time frame: up to 48 hours
other pharmacokinetics parameter Tlag of HLX208
Time frame: up to 48 hours
other pharmacokinetics parameter t1/2 of HLX208
Time frame: up to 48 hours
other pharmacokinetics parameter CL/F of HLX208
Time frame: up to 48 hours
other pharmacokinetics parameter Vd/F of HLX208
Time frame: up to 48 hours
other pharmacokinetics parameter MRT of HLX208
Time frame: up to 48 hours
other pharmacokinetics parameter %AUCex of HLX208
Time frame: up to 48 hours
The incidence and severity of adverse events/serious adverse events
Time frame: up to 17 days after the last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HLX208, Itraconazole 200 mg and Rifampicin in people with NSCLC, run by Shanghai Henlius Biotech at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics parameter Cmax of HLX208 (time frame: up to 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.