Advanced CancerPhase 1NCT04193319
Effect of Fluconazole on PK of Fluzoparib in Healthy Male Subjects
A Phase 1 study testing Fluzoparib and Fluconazole in people with Advanced Cancer, 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 fluconazole on the Pharmacokinetics of Fluzoparib in Healthy male Adults Read more about this study
- Who is it for?
- Ages 35 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Fluzoparib and Fluconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 19 Jul 2019to 12 Sep 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 35 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 35- 50 years old (including both ends), male;
- The body weight is not less than 50 kg, and the body mass index [BMI = weight kg / (height m) 2] is in the range of 18 to 28 (including the critical value);
- Subjects are willing to have no birth plans in the next 6 months and voluntarily take effective contraceptive measures;
- Good health, no history of heart, liver, kidney, digestive tract, nervous system and metabolic abnormalities;
- There are no abnormalities or abnormalities in vital signs and physical examination.
- Understand the research procedures and methods, voluntarily participate in the trial, and sign the informed consent in writing. Fully understand the test content, process and possible adverse reactions;
- Creatinine is less than or equal to the upper limit of normal;
Who cannot join
- Participate in blood donation within 3 months before screening and donate blood volume ≥400mL or blood loss ≥400mL, participate in blood donation within one month and donate blood volume ≥200mL or blood loss ≥200mL, or receive blood transfusion;
- Allergies, including a history of severe drug allergies or drug allergies; a history of allergies to fluzolidine capsules or their excipients.
- Those who have a history of drug and/or alcohol abuse, who are positive for alcohol and drug screening, or who have used drug abuse in the past five years or who have used drugs three months before the test;
- People who smoke alcohol (drinking 14 units of alcohol per week: 1 unit = beer 285 mL, or spirits 25 mL, or wine 100 mL; daily smoking ≥ 5) and can not be smoke-free and alcohol-free during the test period ;
- Those with previous history of cardiovascular disease such as cardiac insufficiency, myocarditis, coronary heart disease, pathological arrhythmia, and stroke;
- Pulmonary diseases, including invasive lung disease, pneumonia, difficulty breathing, etc.;
Show all 21Show fewer
- History of chronic kidney disease, renal insufficiency, and renal anemia;
- Have a history of dysphagia or any history of gastrointestinal disease that affects drug absorption;
- Any uncontrolled peptic ulcer, inflammatory bowel disease, pancreatitis, etc.;
- Anyone who has undergone any surgery within the first 6 months of screening; has undergone any surgery that affects gastrointestinal absorption (including gastrectomy, bowel resection, stomach reduction, etc.)
- A clear history of other major organ diseases such as the nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system within the first month prior to screening (eg uncontrolled diabetes, hypertension) Etc.), making the researcher feel unsuitable for participation in the study;
- Hepatotoxic drugs (such as acetaminophen, statin lipid-lowering drugs, azithromycin, dapsone, clarithromycin, fluconazole, ketoconazole, etc. within 6 months prior to screening (for more than 2 consecutive weeks) Li Fuping);
- Those who have taken any clinical trial drug within 3 months;
- Take any medication that alters liver enzyme activity 28 days prior to taking the study drug (see Appendix 1);
- Take any prescription or over-the-counter medication 14 days before taking the study drug;
- Ingested any vitamin products or herbs 14 days prior to taking the study drug;
- Clinical laboratory tests are abnormal and clinically significant, or other clinical findings indicate the following diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, blood, endocrine, tumor, lung, immune, mental or cardiovascular) disease);
- Concomitant infection with other viruses (anti-HCV, anti-HIV positive, HBsAg positive) or syphilis infection;
- Ingested grapefruit or grapefruit-containing products, caffeine, jaundice or alcoholic foods or beverages (including chocolate, tea, coffee, cola, etc.) 48 hours prior to taking the study drug; strenuous exercise, or other Factors affecting drug absorption, distribution, metabolism, excretion, etc.;
- According to the chest X-ray and abdominal B-ultrasound examination items at the time of screening, abnormalities and clinical significance were confirmed.
- The investigator believes that there are other subjects who are not eligible to participate in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Early Cancer Research Center of Hunan Cancer Hospital
Hunan, Hunan, 410013
About this study
Official title: Study on the Pharmacokinetics of Fluconazole on Single-center, One-arm, Open and Fixed Sequences of Fluzoparib in Healthy Male Subjects
The purpose of this study is to evaluate the Effect of fluconazole on the Pharmacokinetics of Fluzoparib in Healthy male Adults
Read the detailed description
Subjects received oral Fluzoparib 20 mg after D1 single meal, D2-D4 for washing period, D5 started oral fluconazole 400 mg/day/day after meal, continuous administration for 6 days to D10, D8 meal After oral administration of fluconazole 400 mg, a single oral dose of Fluzoparib 20 mg was given immediately.
- Conditions
- Advanced Cancer
- Being tested
- Fluzoparib, Fluconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluzoparibDrug
PARP inhibitor
FluconazoleDrug
inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Not described Receives: Drug: Fluzoparib; Drug: Fluconazole |
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-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-∞
Measured: through study completion，up to 24 weeks
Secondary outcomes (1)
Safety in terms of 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 posted10 Dec 2019
- Study start19 Jul 2019
- Primary completion12 Sep 2019
- Study completion12 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hunan Cancer Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193319
- Sponsor's protocol ID
- FZPL-I-108
- Status last verified
- Nov 2019
- First submitted
- 21 Nov 2019
- Last updated
- 10 Dec 2019
- 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 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Pharmacokinetics of Fluconazole on Single-center, One-arm, Open and Fixed Sequences of Fluzoparib in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04193319
- Acronym / sponsor ID
- FZPL-I-108
- Conditions
- Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Hunan Cancer Hospital
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- 12 Sep 2019 (actual)
- Study completion
- 12 Sep 2019 (actual)
- First posted
- 10 Dec 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 fluconazole on the Pharmacokinetics of Fluzoparib in Healthy male Adults
Detailed description
Subjects received oral Fluzoparib 20 mg after D1 single meal, D2-D4 for washing period, D5 started oral fluconazole 400 mg/day/day after meal, continuous administration for 6 days to D10, D8 meal After oral administration of fluconazole 400 mg, a single oral dose of Fluzoparib 20 mg was given immediately.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Drug: Fluzoparib, Drug: Fluconazole |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age: 35- 50 years old (including both ends), male;
- The body weight is not less than 50 kg, and the body mass index [BMI = weight kg / (height m) 2] is in the range of 18 to 28 (including the critical value);
- Subjects are willing to have no birth plans in the next 6 months and voluntarily take effective contraceptive measures;
- Good health, no history of heart, liver, kidney, digestive tract, nervous system and metabolic abnormalities;
- There are no abnormalities or abnormalities in vital signs and physical examination.
Key exclusion criteria (21 listed)
- Participate in blood donation within 3 months before screening and donate blood volume ≥400mL or blood loss ≥400mL, participate in blood donation within one month and donate blood volume ≥200mL or blood loss ≥200mL, or receive blood transfusion;
- Allergies, including a history of severe drug allergies or drug allergies; a history of allergies to fluzolidine capsules or their excipients.
- Those who have a history of drug and/or alcohol abuse, who are positive for alcohol and drug screening, or who have used drug abuse in the past five years or who have used drugs three months before the test;
- People who smoke alcohol (drinking 14 units of alcohol per week: 1 unit = beer 285 mL, or spirits 25 mL, or wine 100 mL; daily smoking ≥ 5) and can not be smoke-free and alcohol-free during the test period ;
- Those with previous history of cardiovascular disease such as cardiac insufficiency, myocarditis, coronary heart disease, pathological arrhythmia, and stroke;
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 |
| Fluconazoleinhibitor | 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-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-∞
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 10 Dec 2019.
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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 Fluzoparib and Fluconazole in people with Advanced Cancer, 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 7 inclusion and 21 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 10 Dec 2019. 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?
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 10 Dec 2019.