Advanced Solid TumorPhase 1NCT04108676
Effect of Omeprazole on PK of Fluzoparib in Healthy Male Subjects
A Phase 1 study testing Fluzoparib and Omeprazole in people with Advanced Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the Effect of Omeprazole on the Pharmacokinetics of Fluzoparib in Healthy male Adults. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Fluzoparib and Omeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2019to 18 Nov 2019
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 50 years (including both ends), male;
- Male volunteers have a body weight ≥ 50.0 kg and a body mass index (BMI) between 19 and 28 kg/m2 (including both ends);
- Male volunteers are willing to have no birth plans in the next 6 months and voluntarily take effective contraceptive measures;
- Volunteers voluntarily sign written informed consent.
Who cannot join
- Previous or currently suffering from circulatory system (myocarditis, coronary heart disease, pathological arrhythmia, stroke, etc.), endocrine system, nervous system, digestive system (peptic ulcer, colitis, pancreatitis, etc.), respiratory system (Invasive lung disease, pneumonia, dyspnea, etc., urogenital system (chronic kidney disease, renal insufficiency, renal anemia), hematology, immunology, psychiatry and metabolic abnormalities, etc. Result of any other disease;
- A history of allergies to drugs, foods or other substances; allergies, including a history of severe drug allergies or drug allergies; a history of allergies to Fluzoparib capsules or omeprazole magnesium enteric-coated tablets
- Those who have undergone surgery within 4 weeks prior to the trial or who plan to undergo surgery during the study;
- Those who have taken any drugs or health care products (including Chinese herbal medicines) within 14 days before the test;
- Any drug that inhibits or induces liver metabolism of the drug within 30 days prior to the test (eg, inducer - barbiturate, carbamazepine, phenytoin, glucocorticoid, omeprazole; inhibitor - SSRI resistance) Depressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines;
- Those who participated in any clinical trial and took any clinical trial drug within 3 months prior to the trial;
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- Donate blood or massive blood loss (≥200 mL), receive blood transfusion or use blood products within 3 months before enrollment;
- One or more non-pharmaceutical contraceptives cannot be used during the volunteer trial;
- Those who have special requirements for diet and cannot follow the unified diet;
- Drink excessive amounts of tea, coffee and/or caffeinated beverages (8 cups or more, 1 cup = 250 mL) per day;
- smokers or smokers with more than 5 cigarettes per day for the first 3 months of the trial or who cannot stop using any tobacco products during the trial period;
- Alcoholics or those who regularly drink alcohol within 6 months prior to the test, ie drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) or during the test period Stop using any alcoholic products;
- Drug abusers or soft drugs (eg marijuana) 3 months prior to the trial or hard drugs (eg cocaine, phencyclidine, etc.) 1 year prior to the trial; and nicotinic positive volunteers
- Abnormal vital signs (systolic blood pressure <90 mmHg or >140 mmHg, diastolic blood pressure <50 mmHg or >90 mmHg; pulse <50 bpm or >100 bpm) or physical examination, electrocardiogram, laboratory examination, imaging examination abnormalities Clinically significant (subject to the judgment of the clinical research doctor);
- have a history of dysphagia or any history of gastrointestinal disease that affects drug absorption;
- Those who have undergone any surgery within the first 6 months of screening; have previously undergone any surgery that affects gastrointestinal absorption (including gastrectomy, bowel resection, stomach reduction surgery, etc.);
- The volunteer refused to discontinue any beverage containing methylxanthine, such as caffeine (coffee, tea, cola, chocolate, etc.) or alcoholic beverages or any juice, 48 hours before the study drug was administered until the end of the study;
- Creatinine clearance (CLCr) <80 mL/min, or creatinine above the upper limit of normal;
- Volunteers may not be able to complete the study for other reasons or those the investigator believes should not be included.
Trial locations and contacts
1 site in 1 country.
China1 site
The third xiangya hospital Hospital,of central south university
Changsha, Hunan, 410013
About this study
Official title: a Single-center, One-arm, Open, and Fixed Sequences Study to Evaluate the Effects of Omeprazole on the Pharmacokinetics of Fluzoparib in Healthy Male Volunteers
The purpose of this study is to evaluate the Effect of Omeprazole on the Pharmacokinetics of Fluzoparib in Healthy male Adults.
- Conditions
- Advanced Solid Tumor
- Being tested
- Fluzoparib, Omeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluzoparibDrug
PARP inhibitor
OmeprazoleDrug
proton pump inhibitor
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | Drug: Fluzoparib Drug: Omeprazole Receives: Drug: Fluzoparib; Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of Fluzoparib:
Cmax
Measured: through study completion, up to 24 weeks
Area Under the Plasma Concentration-Time Curve From 0 to t of Fluzoparib:
AUC0-t
Measured: through study completion, up to 24 weeks
Area Under the Plasma Concentration-Time Curve From 0 to infinity of Fluzoparib:
AUC0-∞ (if available)
Measured: through study completion, up to 24 weeks
Secondary outcomes (1)
Safety in terms of Adverse Events Assessments
Adverse Events Assessments (NCI-CTC AE 5.0)
Measured: through study completion, up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start7 Sep 2019
- Primary completion18 Sep 2019
- Study completion18 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- repeated oral doses of Omeprazole on the pharmacokinetic profile of a single dose of Fluzoparib
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guoping Yang, PhD, Principal investigator, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108676
- Sponsor's protocol ID
- FZPL-I-111
- Status last verified
- Sep 2021
- First submitted
- 19 Sep 2019
- Last updated
- 29 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li L, Xiang YX, Yang GP, Zhang XF, Yang XY, Yang S, Huang J. Pharmacokinetic effects of proton pump inhibitors on the novel PARP inhibitor fluzoparib: a single-arm, fixed-sequence trial in male healthy volunteers. Invest New Drugs. 2021 Jun;39(3):796-802. doi: 10.1007/s10637-020-01034-w. Epub 2021 Jan 9.
PubMed 33420642
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Single-center, One-arm, Open, and Fixed Sequences Study to Evaluate the Effects of Omeprazole on the Pharmacokinetics of Fluzoparib in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT04108676
- Acronym / sponsor ID
- FZPL-I-111
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The Third Xiangya Hospital of Central South University
- Study start
- 7 Sep 2019 (actual)
- Primary completion
- 18 Sep 2019 (actual)
- Study completion
- 18 Nov 2019 (actual)
- First posted
- 30 Sep 2019 (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 Effect of Omeprazole on the Pharmacokinetics of Fluzoparib in Healthy male Adults.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- repeated oral doses of Omeprazole on the pharmacokinetic profile of a single dose of Fluzoparib
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Drug: Fluzoparib, Drug: OmeprazoleDrug: Fluzoparib Drug: Omeprazole |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18 to 50 years (including both ends), male;
- Male volunteers have a body weight ≥ 50.0 kg and a body mass index (BMI) between 19 and 28 kg/m2 (including both ends);
- Male volunteers are willing to have no birth plans in the next 6 months and voluntarily take effective contraceptive measures;
- Volunteers voluntarily sign written informed consent.
Key exclusion criteria (19 listed)
- Previous or currently suffering from circulatory system (myocarditis, coronary heart disease, pathological arrhythmia, stroke, etc.), endocrine system, nervous system, digestive system (peptic ulcer, colitis, pancreatitis, etc.), respiratory system (Invasive lung disease, pneumonia, dyspnea, etc., urogenital system (chronic kidney disease, renal insufficiency, renal anemia), hematology, immunology, psychiatry and metabolic abnormalities, etc. Result of any other disease;
- A history of allergies to drugs, foods or other substances; allergies, including a history of severe drug allergies or drug allergies; a history of allergies to Fluzoparib capsules or omeprazole magnesium enteric-coated tablets
- Those who have undergone surgery within 4 weeks prior to the trial or who plan to undergo surgery during the study;
- Those who have taken any drugs or health care products (including Chinese herbal medicines) within 14 days before the test;
- Any drug that inhibits or induces liver metabolism of the drug within 30 days prior to the test (eg, inducer - barbiturate, carbamazepine, phenytoin, glucocorticoid, omeprazole; inhibitor - SSRI resistance) Depressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines;
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 |
|---|---|---|
| FluzoparibPARP inhibitor | Drug | single arm |
| Omeprazoleproton pump inhibitor | Drug | single arm |
Primary outcome
Maximum Plasma Concentration (Cmax) of Fluzoparib:
Time frame: through study completion, up to 24 weeks
Cmax
Area Under the Plasma Concentration-Time Curve From 0 to t of Fluzoparib:
Time frame: through study completion, up to 24 weeks
AUC0-t
Area Under the Plasma Concentration-Time Curve From 0 to infinity of Fluzoparib:
Time frame: through study completion, up to 24 weeks
AUC0-∞ (if available)
1 secondary outcome
Safety in terms of Adverse Events Assessments
Time frame: through study completion, up to 24 weeks
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 29 Jul 2022.
- Derived from this study: PubMed 33420642Li L, Xiang YX, Yang GP, Zhang XF, Yang XY, Yang S, Huang J. Pharmacokinetic effects of proton pump inhibitors on the novel PARP inhibitor fluzoparib: a single-arm, fixed-sequence trial in male healthy volunteers. Invest New Drugs. 2021 Jun;39(3):796-802. doi: 10.1007/s10637-020-01034-w. Epub 2021 Jan 9.
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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.
Guoping Yang, PhD principal investigator
The Third Xiangya Hospital of Central South University
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 Fluzoparib and Omeprazole in people with Advanced 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 4 inclusion and 19 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 29 Jul 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) of Fluzoparib: (time frame: through study completion, up to 24 weeks). 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?
On the ClinicalTrials.gov record for NCT04108676, which also lists 1 linked publication.
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 29 Jul 2022.