Advanced Solid TumorPhase 1NCT06372223
A Food Effect Study of SPH5030 Tablets.
A Phase 1 study testing SPH5030 in people with Advanced Solid Tumor, run by Shanghai Pharmaceuticals Holding Co., Ltd at 1 site in China.
Trial summary
The purpose of this study is to evaluate the food effect of SPH5030 tablets in healthy Chinese adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- SPH5030
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2024to 25 Mar 2024
- 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
- Fully informed subjects who voluntarily sign the ICF；
- Females who are not pregnant, non-lactating. Subjects who complied with the contraceptive requirements of the protocol.
Who cannot join
- Subjects with any medical history assessed by the investigator that unsuitable for participation in a clinical study;
- Subjects with abnormal test results during the screening period；
- Subjects who have difficulty in venous blood collection;
- Subjects who cannot accept uniform diet or have difficulty swallowing;
- Other situations that meet the exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Open, Single-dose, Two-cycle, Two-sequence Crossover Food Effect Study of SPH5030 Tablets in Healthy Chinese Adult Subjects.
The purpose of this study is to evaluate the food effect of SPH5030 tablets in healthy Chinese adult subjects.
- Conditions
- Advanced Solid Tumor
- Being tested
- SPH5030
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPH5030Drug
SPH5030 tablets：400mg,orally, Dosing in the fasted state followed by fed dosing.
SPH5030Drug
SPH5030 tablets：400mg, orally, Dosing in the fed state followed by fasted dosing.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Drug: SPH5030 |
| Group B | Experimental | Not described Receives: Drug: SPH5030 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
PK（Pharmacokinetics）
Measured: Approximately 2 months
Peak time（Tmax）
PK（Pharmacokinetics）
Measured: Approximately 2 months
Area under the plasma concentration versus time curve (AUC)
PK（Pharmacokinetics）
Measured: Approximately 2 months
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events
Adverse event type, incidence, duration
Measured: Approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start4 Mar 2024
- Primary completion25 Mar 2024
- Study completion25 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372223
- Sponsor's protocol ID
- SPH5030-102
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Open, Single-dose, Two-cycle, Two-sequence Crossover Food Effect Study of SPH5030 Tablets in Healthy Chinese Adult Subjects.
- ClinicalTrials.gov ID
- NCT06372223
- Acronym / sponsor ID
- SPH5030-102
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 17 Apr 2024 (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.
The purpose of this study is to evaluate the food effect of SPH5030 tablets in healthy Chinese adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: SPH5030 |
| Group B | Experimental | Drug: SPH5030 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Fully informed subjects who voluntarily sign the ICF；
- Females who are not pregnant, non-lactating. Subjects who complied with the contraceptive requirements of the protocol.
Key exclusion criteria (5 listed)
- Subjects with any medical history assessed by the investigator that unsuitable for participation in a clinical study;
- Subjects with abnormal test results during the screening period；
- Subjects who have difficulty in venous blood collection;
- Subjects who cannot accept uniform diet or have difficulty swallowing;
- Other situations that meet the exclusion criteria.
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 |
|---|---|---|
| SPH5030SPH5030 tablets：400mg,orally, Dosing in the fasted state followed by fed dosing. | Drug | Group A |
| SPH5030SPH5030 tablets：400mg, orally, Dosing in the fed state followed by fasted dosing. | Drug | Group B |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: Approximately 2 months
PK（Pharmacokinetics）
Peak time（Tmax）
Time frame: Approximately 2 months
PK（Pharmacokinetics）
Area under the plasma concentration versus time curve (AUC)
Time frame: Approximately 2 months
PK（Pharmacokinetics）
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Approximately 2 months
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 17 Apr 2024.
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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 SPH5030 in people with Advanced Solid Tumor, run by Shanghai Pharmaceuticals Holding Co., Ltd 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 2 inclusion and 5 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 17 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?
Peak Plasma Concentration (Cmax) (time frame: Approximately 2 months). 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 17 Apr 2024.