Solid TumorPhase 1NCT05440006
A Study of Food Effect on the Pharmacokinetics of Fuzuloparib Capsules in Chinese Healthy Adult Subjects
A Phase 1 study testing Fuzuloparib in people with Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The objective of the study is to assess the effect of food on the pharmacokinetics, and safety of Fuzuloparib Capsules in healthy subject. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Fuzuloparib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2022to 20 Jul 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female subjects over 18 years;
- Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) of 19.0 to 26.0 kg /m2 (inclusive);
- Participants should have no fertility plan from signing the informed consent until 6 months after the last dose, and take effective contraceptive measures.
Who cannot join
- Subjects with evidence of disease or major surgery;
- History of drug allergy;
- Treatment with other investigational drug within 3 months, use of any prescription drugs, Chinese herbal supplements within 4 weeks, and/or need to use any over-the-counter (OTC), food supplements within 2 weeks before the first dose or during the trial;
- Subjects refuse to stop drinking xanthine-rich beverages or foods at 48 hours before the first dose until the end of the study, and subjects refuse to stop any beverage or food containing grapefruit 7 days before the first dose;
- Those who have heavy smokers, alcoholics or drug abuse
- Lactating female subjects or fertile female subjects
- Those with clinically significant abnormality of physical examination, vital signs and laboratory test during the screening period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Open, Two Cycle, Two Sequence, Cross Reference Designed Study on the Effect of Food on the Pharmacokinetics of Fuzuloparib Capsules in Chinese Healthy Adult Subjects
The objective of the study is to assess the effect of food on the pharmacokinetics, and safety of Fuzuloparib Capsules in healthy subject.
- Conditions
- Solid Tumor
- Being tested
- Fuzuloparib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FuzuloparibDrug
Fuzuloparib Capsules; 150mg; single dose per cycle.
| Study group | Role | What they receive |
|---|---|---|
| Fed+ Fasted | Experimental | The first cycle with high-fat meal, the second cycle under fasting. Receives: Drug: Fuzuloparib |
| Fasted + Fed | Experimental | The first cycle under fasting, the second cycle with high-fat meal. Receives: Drug: Fuzuloparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
Measured: day 1 to day 10
Area under the plasma concentration versus time curve from time 0 to last time of measurable concentration (AUC0-t)
Measured: day 1 to day 10
Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-∞ )
Measured: day 1 to day 10
Secondary outcomes (1)
The incidence and severity of adverse events/serious adverse events
Measured: from ICF signing date to approximate day 23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start3 Jul 2022
- Primary completion20 Jul 2022
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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
- Crossover
- Model description
- There will be 20 volunteers to receive the treatment, and each treatment will be followed by 72 hours of blood sampling for pharmacokinetic and safety.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440006
- Sponsor's protocol ID
- SHR3162-I-122
- Status last verified
- Sep 2022
- First submitted
- 27 Jun 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open, Two Cycle, Two Sequence, Cross Reference Designed Study on the Effect of Food on the Pharmacokinetics of Fuzuloparib Capsules in Chinese Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05440006
- Acronym / sponsor ID
- SHR3162-I-122
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jul 2022 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 30 Jun 2022 (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 objective of the study is to assess the effect of food on the pharmacokinetics, and safety of Fuzuloparib Capsules in healthy subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There will be 20 volunteers to receive the treatment, and each treatment will be followed by 72 hours of blood sampling for pharmacokinetic and safety.
| Arm | Type | Receives |
|---|---|---|
| Fed+ Fasted | Experimental | Drug: FuzuloparibThe first cycle with high-fat meal, the second cycle under fasting. |
| Fasted + Fed | Experimental | Drug: FuzuloparibThe first cycle under fasting, the second cycle with high-fat meal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male and female subjects over 18 years;
- Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) of 19.0 to 26.0 kg /m2 (inclusive);
- Participants should have no fertility plan from signing the informed consent until 6 months after the last dose, and take effective contraceptive measures.
Key exclusion criteria (7 listed)
- Subjects with evidence of disease or major surgery;
- History of drug allergy;
- Treatment with other investigational drug within 3 months, use of any prescription drugs, Chinese herbal supplements within 4 weeks, and/or need to use any over-the-counter (OTC), food supplements within 2 weeks before the first dose or during the trial;
- Subjects refuse to stop drinking xanthine-rich beverages or foods at 48 hours before the first dose until the end of the study, and subjects refuse to stop any beverage or food containing grapefruit 7 days before the first dose;
- Those who have heavy smokers, alcoholics or drug abuse
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 |
|---|---|---|
| FuzuloparibFuzuloparib Capsules; 150mg; single dose per cycle. | Drug | Fasted + Fed, Fed+ Fasted |
Primary outcome
Maximum Plasma Concentration (Cmax)
Time frame: day 1 to day 10
Area under the plasma concentration versus time curve from time 0 to last time of measurable concentration (AUC0-t)
Time frame: day 1 to day 10
Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-∞ )
Time frame: day 1 to day 10
1 secondary outcome
The incidence and severity of adverse events/serious adverse events
Time frame: from ICF signing date to approximate day 23
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 8 Sep 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Solid Tumor
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Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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 Fuzuloparib in people with Solid Tumor, run by Jiangsu HengRui Medicine 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 3 inclusion and 7 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 8 Sep 2022. 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?
Maximum Plasma Concentration (Cmax) (time frame: day 1 to day 10). 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 8 Sep 2022.