TumorPhase 1NCT05147727
Drug-drug Interaction Study Between Fluconazole and Famitinib in Healthy Subjects
A Phase 1 study testing Fluconazole、Famitinib in people with Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
An open-label, fixed-sequence, drug-drug interaction study to evaluate the effects of fluconazole on the pharmacokinetics and safety of famitinib in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tumor
- What is being tested?
- Fluconazole、Famitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 14 Mar 2022to 2 May 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
- With my consent and informed consent, I am willing and able to complete the study in accordance with the requirements of the experimental protocol;
- Healthy male or female aged 18-45 years (including threshold) on the date of signing the informed consent form;
- Male body weight ≥ 50 kg, female body weight ≥ 45 kg, body mass index (BMI) in the range of 19.0-26.0 kg / m2 (including the critical value);
- Physical examination, vital signs, laboratory measurements (blood routine, blood biochemistry, urine routine test, coagulation function, etc.), 12-lead ECG, abdominal B-ultrasound, chest X-ray, etc. are normal or abnormal, but the researcher has no clinical significance according to NCI CTCAE 5.0 standard;
- Fertile subjects had no family planning and had to take acceptable contraceptive measures and no plans to donate eggs and sperm within 3 months from the date of signing informed consent to the last medication; the serum pregnancy test of fertile women within 24 hours before the first administration of the study drug should be negative.
Who cannot join
- Those who have previously suffered from primary diseases of important organs, including but not limited to neuropsychiatric, cardiovascular, digestive tract, respiratory system, urinary, endocrine, blood, immune and other diseases, which are judged by the researchers to be unsuitable for the trial;
- Subjects who have received any previous operation affecting gastrointestinal absorption;
- Subjects who had received any surgery within 6 months before screening, or planned to undergo surgery during the study period;
- Those who lost blood or donated more than 400 ml or received blood transfusion within 3 months before screening;
- HBsAg positive, HCVAb positive, HIV antibody positive, syphilis antibody positive;
- History of drug use in the past 5 years or drug abuse, or drug screening positive;
Show all 15Show fewer
- Smoking and alcohol addict and unable to stop smoking during the test period; those with positive alcohol screening; those with positive nicotine screening;
- Subjects who have swallowing resistance or obstacle that will affect the drug absorption;
- Allergic constitution, including severe drug allergy or drug allergy history; known allergy to fluconazole and famitinib or its excipients;
- Those who have participated in other clinical trials and taken the study drug within 3 months before taking the study drug for the first time;
- Inducers or inhibitors of CYP3A4 were taken within 4 weeks before the first administration of study drug;
- Taking any prescription drug, over-the-counter drug, traditional Chinese medicine or food supplement within 2 weeks before taking the study drug for the first time;
- Ingestion of grapefruit containing products, fruit juice, food or beverage containing methylxanthine or alcohol within 48 hours before taking the study drug for the first time; taking strenuous exercise; or having other factors affecting the absorption, distribution, metabolism and excretion of drugs;
- Lactating women;
- The researchers considered that the subjects had any other factors that were not suitable for the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
About this study
Official title: A Single-center, Open-label, Fixed-sequence Study to Evaluate the Effects of Fluconazole on the Pharmacokinetics and Safety of Famitinib in Healthy Subjects
An open-label, fixed-sequence, drug-drug interaction study to evaluate the effects of fluconazole on the pharmacokinetics and safety of famitinib in healthy subjects.
- Conditions
- Tumor
- Being tested
- Fluconazole、Famitinib
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluconazole、FamitinibDrug
Fluconazole, once daily on Days 12 to 24; Famitinib, once daily on Days 1 and 15
| Study group | Role | What they receive |
|---|---|---|
| Fluconazole and Famitinib interaction | Experimental | Not described Receives: Drug: Fluconazole、Famitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed serum concentration (Cmax) for famitinib
Measured: Day 1 to Day 25
Area under the concentration-time curve from time zero to time t (AUC0-t,) for famitinib
Measured: Day 1 to Day 25
Area under the concentration-time curve extrapolated to infinity (AUC0-∞.) for famitinib (if applicable)
Measured: Day 1 to Day 25
Secondary outcomes (10)
Time to maximum observed serum concentration (Tmax) for famitinib
Measured: Day 1 to Day 25
Time to elimination half-life (t1/2) for famitinib
Measured: Day 1 to Day 25
Apparent oral clearance (CL/F) for famitinib
Measured: Day 1 to Day 25
Apparent Volume of Distribution (Vz/F) for famitinib
Measured: Day 1 to Day 25
Tmax for famitinib metabolite SHR116637
Measured: Day 1 to Day 25
Cmax for famitinib metabolite SHR116637
Measured: Day 1 to Day 25
AUC0-t, for famitinib metabolite SHR116637
Measured: Day 1 to Day 25
AUC0-∞. for famitinib metabolite SHR116637(if applicable)
Measured: Day 1 to Day 25
t1/2 for famitinib metabolite SHR116637
Measured: Day 1 to Day 25
The incidence and severity of adverse events/serious adverse events (based on NCI-CTC AE 5.0)
Measured: Day 1 to Day 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start14 Mar 2022
- Primary completion2 May 2022
- Study completion2 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Fluconazole and famitinib interaction
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT05147727
- Sponsor's protocol ID
- FMTN-I-108
- Status last verified
- Dec 2022
- First submitted
- 6 Dec 2021
- Last updated
- 23 Dec 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 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Fixed-sequence Study to Evaluate the Effects of Fluconazole on the Pharmacokinetics and Safety of Famitinib in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05147727
- Acronym / sponsor ID
- FMTN-I-108
- Conditions
- Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 2 May 2022 (actual)
- First posted
- 7 Dec 2021 (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.
An open-label, fixed-sequence, drug-drug interaction study to evaluate the effects of fluconazole on the pharmacokinetics and safety of famitinib in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Fluconazole and famitinib interaction
| Arm | Type | Receives |
|---|---|---|
| Fluconazole and Famitinib interaction | Experimental | Drug: Fluconazole、Famitinib |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- With my consent and informed consent, I am willing and able to complete the study in accordance with the requirements of the experimental protocol;
- Healthy male or female aged 18-45 years (including threshold) on the date of signing the informed consent form;
- Male body weight ≥ 50 kg, female body weight ≥ 45 kg, body mass index (BMI) in the range of 19.0-26.0 kg / m2 (including the critical value);
- Physical examination, vital signs, laboratory measurements (blood routine, blood biochemistry, urine routine test, coagulation function, etc.), 12-lead ECG, abdominal B-ultrasound, chest X-ray, etc. are normal or abnormal, but the researcher has no clinical significance according to NCI CTCAE 5.0 standard;
- Fertile subjects had no family planning and had to take acceptable contraceptive measures and no plans to donate eggs and sperm within 3 months from the date of signing informed consent to the last medication; the serum pregnancy test of fertile women within 24 hours before the first administration of the study drug should be negative.
Key exclusion criteria (15 listed)
- Those who have previously suffered from primary diseases of important organs, including but not limited to neuropsychiatric, cardiovascular, digestive tract, respiratory system, urinary, endocrine, blood, immune and other diseases, which are judged by the researchers to be unsuitable for the trial;
- Subjects who have received any previous operation affecting gastrointestinal absorption;
- Subjects who had received any surgery within 6 months before screening, or planned to undergo surgery during the study period;
- Those who lost blood or donated more than 400 ml or received blood transfusion within 3 months before screening;
- HBsAg positive, HCVAb positive, HIV antibody positive, syphilis antibody positive;
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 |
|---|---|---|
| Fluconazole、FamitinibFluconazole, once daily on Days 12 to 24; Famitinib, once daily on Days 1 and 15 | Drug | Fluconazole and Famitinib interaction |
Primary outcome
Maximum observed serum concentration (Cmax) for famitinib
Time frame: Day 1 to Day 25
Area under the concentration-time curve from time zero to time t (AUC0-t,) for famitinib
Time frame: Day 1 to Day 25
Area under the concentration-time curve extrapolated to infinity (AUC0-∞.) for famitinib (if applicable)
Time frame: Day 1 to Day 25
10 secondary outcomes
Time to maximum observed serum concentration (Tmax) for famitinib
Time frame: Day 1 to Day 25
Time to elimination half-life (t1/2) for famitinib
Time frame: Day 1 to Day 25
Apparent oral clearance (CL/F) for famitinib
Time frame: Day 1 to Day 25
Apparent Volume of Distribution (Vz/F) for famitinib
Time frame: Day 1 to Day 25
Tmax for famitinib metabolite SHR116637
Time frame: Day 1 to Day 25
Cmax for famitinib metabolite SHR116637
Time frame: Day 1 to Day 25
AUC0-t, for famitinib metabolite SHR116637
Time frame: Day 1 to Day 25
AUC0-∞. for famitinib metabolite SHR116637(if applicable)
Time frame: Day 1 to Day 25
t1/2 for famitinib metabolite SHR116637
Time frame: Day 1 to Day 25
The incidence and severity of adverse events/serious adverse events (based on NCI-CTC AE 5.0)
Time frame: Day 1 to Day 25
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 23 Dec 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Tumor
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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 Fluconazole、Famitinib in people with 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 5 inclusion and 15 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 23 Dec 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 observed serum concentration (Cmax) for famitinib (time frame: Day 1 to Day 25). 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 23 Dec 2022.