Antitumor DrugPhase 1NCT06652997
SPH3348 Tablets in a Single-center, Randomized, Open-label, Single-dose, Two-period, Two-sequence Crossover Design Food Effect Study in Healthy Chinese Subjects
A Phase 1 study testing SPH3348 in people with Antitumor Drug and Pharmacokinetics, run by West China Second University Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the pharmacokinetic (PK) characteristics of single oral doses of SPH3348 tablets in healthy subjects under fasting and fed conditions, as well as the impact of food on PK. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Antitumor Drug, Pharmacokinetics
- What is being tested?
- SPH3348
- 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
- 15 Jul 2022to 2 Nov 2022
- 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
- To be eligible for this trial, participants must meet all the following inclusion criteria:
- Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial, and sign an informed consent form, being able to complete all trial processes as required by the protocol;
- Be healthy adult males or females aged 18 to 45 years, inclusive of the boundary values;
- Have a body mass index (BMI) of 18 to 26 kg/m^2, inclusive of the boundary values, with a minimum weight of 50 kg for males and 45 kg for females;
- Participants with potential for fertility must use at least one medically recognized contraceptive method during the study treatment period and for one year after the end of the study treatment (contraceptive methods and requirements are detailed in Appendix 1); females must undergo a pregnancy test during the screening period or at admission, with a result that must be negative; and must not be breastfeeding.
Who cannot join
- Participants who meet any of the following exclusion criteria will be excluded:
- Have a history of clinically significant diseases in the heart, liver, kidney, respiratory, hematopoietic, nervous, urinary reproductive systems, or mental diseases, severe infections, severe trauma, or major surgical procedures within 3 months before administration, or plan to undergo surgical procedures during the study;
- Have a history of suspected allergy to the study drug or any component of the study drug (including drug allergies and food allergies, etc.);
- Have a history of diseases or have received treatments that affect the absorption, distribution, metabolism, and excretion of drugs in the body, as determined by the investigator, such as gastrectomy, gastrointestinal anastomosis, laparoscopic Roux-en-Y gastric bypass surgery, etc.;
- Have difficulty with venous blood collection or have a history of fainting from needles or blood or physical conditions that cannot withstand intensive blood collection;
- Have an average daily smoking consumption of more than 5 cigarettes in the 3 months before screening or are unable to give up the use of tobacco products during the entire trial period;
Show all 18Show fewer
- Have a history of drug use, a history of drug abuse (such as THC, morphine, ketamine, methamphetamine, MDMA) within 6 months before screening, or have a positive urine drug screen;
- Consume more than 14 units of alcohol per week in the 6 months before screening (1 standard unit = 14 g of alcohol = 360 mL of beer or 45 mL of liquor with 40% alcohol or 150 mL of wine) or are unable to abstain from alcohol during the trial period, or have an abnormal alcohol breath test (acceptable range: 0~3 mg/100 mL);
- Have used any prescription drugs, over-the-counter drugs, Chinese herbal medicine, or health products within 4 weeks before the start of the trial;
- Be vegetarians, have dietary restrictions that cannot comply with a uniform diet, or have difficulty swallowing;
- Have consumed foods that affect liver enzymes (such as grapefruit and grapefruit-containing products) or any foods rich in xanthine substances (such as coffee, tea, chocolate, cocoa, milk tea, etc.) within 48 hours before taking medication, or have engaged in vigorous exercise;
- Test positive for Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (HCV-Ab), Human Immunodeficiency Virus antibody (HIV-Ab), or syphilis antibody;
- Have abnormal results in vital sign assessment, physical examination, laboratory tests, 12-lead ECG, and chest PA X-ray that are clinically significant;
- Have a corrected QT interval (QTcB) obtained from a 12-lead ECG at rest of >450 ms in males and >470 ms in females at screening, or have other abnormalities deemed clinically significant by the investigator;
- Have participated in other drug or medical device clinical trials within 3 months before screening;
- Have received or plan to receive live (attenuated) vaccines during the trial process or within one month after administration;
- Have donated blood or lost a total of ≥200 mL of blood within 1 month before screening, or have donated blood or lost ≥400 mL within 3 months before administration; have received blood transfusions or blood products;
- Are deemed ineligible for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to evaluate the pharmacokinetic (PK) characteristics of single oral doses of SPH3348 tablets in healthy subjects under fasting and fed conditions, as well as the impact of food on PK.
- Conditions
- Antitumor Drug, Pharmacokinetics
- Being tested
- SPH3348
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPH3348Drug
Single oral administration of SPH3348 tablets（480mg） under fasting and fed conditions
| Study group | Role | What they receive |
|---|---|---|
| Single oral administration of SPH3348 tablets under fasting condition | Active comparator | Single oral administration of SPH3348 tablets（480 mg） under fasting condition Receives: Drug: SPH3348 |
| Single oral administration of SPH3348 tablets under fed condition | Active comparator | Single oral administration of SPH3348 tablets（480 mg） under fed condition Receives: Drug: SPH3348 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Peak Concentration
Measured: Cmax occurs within 1.5 to 4 hours after dosing
Tmax
"Time to Reach Maximum Concentration
Measured: From administration to reaching maximum plasma concentration, typically around 3 hours
AUC0-t
Measured: AUC0-t is measured from time 0 to 32 hours post-dose
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: through study completion, an average of 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start15 Jul 2022
- Primary completion14 Aug 2022
- Study completion2 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antitumor DrugStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, Open-label, Single-dose, Two-period, Two-sequence Crossover Design
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Second University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Pharmaceuticals Holding Co., Ltd
- Responsible party
- Principal investigator, Yu Qin, West China Second University Hospital
- Investigators
- yu, Principal investigator, National Drug Clinical Trial Institution of West China Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652997
- Sponsor's protocol ID
- SPH3348-102
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPH3348 Tablets in a Single-center, Randomized, Open-label, Single-dose, Two-period, Two-sequence Crossover Design Food Effect Study in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT06652997
- Acronym / sponsor ID
- SPH3348-102
- Conditions
- Antitumor Drug, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- West China Second University HospitalUniversity, hospital or other
- Collaborators
- Shanghai Pharmaceuticals Holding Co., Ltd
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 14 Aug 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 22 Oct 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 goal of this clinical trial is to evaluate the pharmacokinetic (PK) characteristics of single oral doses of SPH3348 tablets in healthy subjects under fasting and fed conditions, as well as the impact of food on PK.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, Open-label, Single-dose, Two-period, Two-sequence Crossover Design
| Arm | Type | Receives |
|---|---|---|
| Single oral administration of SPH3348 tablets under fasting condition | Active comparator | Drug: SPH3348Single oral administration of SPH3348 tablets（480 mg） under fasting condition |
| Single oral administration of SPH3348 tablets under fed condition | Active comparator | Drug: SPH3348Single oral administration of SPH3348 tablets（480 mg） under fed condition |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- To be eligible for this trial, participants must meet all the following inclusion criteria:
Key exclusion criteria (18 listed)
- Participants who meet any of the following exclusion criteria will be excluded:
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 |
|---|---|---|
| SPH3348Single oral administration of SPH3348 tablets（480mg） under fasting and fed conditions | Drug | Single oral administration of SPH3348 tablets under fasting condition, Single oral administration of SPH3348 tablets under fed condition |
Primary outcome
Cmax
Time frame: Cmax occurs within 1.5 to 4 hours after dosing
Peak Concentration
Tmax
Time frame: From administration to reaching maximum plasma concentration, typically around 3 hours
"Time to Reach Maximum Concentration
AUC0-t
Time frame: AUC0-t is measured from time 0 to 32 hours post-dose
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: through study completion, an average of 17 days
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 22 Oct 2024.
Related trials for Antitumor Drug
RecruitingPhase 3
Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial
Metastatic Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08098488 in People With Advanced Solid Tumors.
Pancreatic Ductal Adenocarcinoma, Esophageal Cancer
RecruitingPhase 1
IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas
B-cell Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma
Not yet recruitingPhase 1
A Study of MC001 in Patients With Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) and Other Folate Receptor Alpha (FRα)-Expressing Solid Tumors
Pancreatic Ductal Adenocarcinoma (PDAC), Advanced Solid Tumor Cancer
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated CLL/SLL
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
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.
yu principal investigator
National Drug Clinical Trial Institution of West China Second Hospital
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 SPH3348 in people with Antitumor Drug and Pharmacokinetics, run by West China Second University Hospital 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 5 inclusion and 18 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 22 Oct 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?
Cmax (time frame: Cmax occurs within 1.5 to 4 hours after dosing). 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 22 Oct 2024.