HyperuricemiaPhase 1NCT04622124
A Safety and Tolerability Study of FCN-207 in Healthy Volunteers
A Phase 1 study testing fasted vs. high-fat meal in people with Hyperuricemia, run by Fochon Pharmaceuticals, Ltd. at 1 site in China.
Trial summary
This research study is studying an investigational drug called FCN-207 in healthy adult males or females. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperuricemia
- What is being tested?
- fasted vs. high-fat meal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2020to 7 Jun 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
- Male or female healthy subjects who were aged at 18 - 45 years；
- Weight ≥ 50 kg，Body Mass Index（BMI）＝ Weight（kg）/（Height）2（m2）， BMI at 19 - 28 kg/m2（Including boundary value）；
- No birth plan during the trial period and within 6 months after completion and are willing to use non-hormonal contraceptive measures;
- To understand the research procedure and method, voluntarily participate in the experiment and signed the informed consent；
Who cannot join
- Blood uric acid < 4 mg/dL（240 μmol/L）or >7 mg/dL（420 μmol/L）；
- After inquiry and physical examination，subjects who have had cardiovascular, liver, kidney, gastrointestinal respiratory, neurological, mental, immune, blood, endocrine and metabolic diseases, or clinically significant symptoms/signs, or self-report the history of diseases；
- Physical examination（Height, weight, breathing, pulse, blood pressure, chest and abdominal examinations, etc）or the laboratory indexes [ Blood routine, urine routine, blood biochemistry ( including myocardial enzyme spectrum ), blood amylase and urine amylase, blood coagulation test, infectious disease screening, etc] were abnormal and have clinical significance；12-lead ECG、B-ultrasonography and chest radiograph is abnormal and have clinical significance.
- Subjects who have had a history of smoking (more than 5 cigarettes per day) and drinking alcohol (more than 15g of alcohol per day for women and more than 25g for men (15g is equivalent to 450ml of beer, 150ml of wine or 50ml of low-alcohol liquor), more than twice a week), and had a history of drug abuse;
- According to the investigator's judgment, the subject may be allergic to the test drug or any of its ingredients；
- Subjects with a history of hyperuricemia and/or gout disease, or have received drugs that affect uric acid synthesis, metabolism and excretions within 1month before the screening; A history of kidney stones or B-mode ultrasonography during screening showed kidney stones;
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- Alanine aminotransferase and/or aspartate aminotransferase >1.5 times normal upper limit, and/or total bilirubin>1.5 times normal upper limit；
- eCRCL ≤ 90mL/min ，Calculation formula：Male（140-AGE）×BW（KG）/（72×SCR），Female（140-AGE）×BW（KG）/（72×SCR）×0.85，SCR unit：μmol/L /dl；
- Subjects who have had any surgery within 6 months before screening;
- Subjects who have had participated in blood donation volume is ≥ 400 ml or have received blood transfusion within 3 months before the screening；
- Subjects who have had participated in a clinical trial of any drug or medical device within 3 months before the screening；
- Subject who have had any prescription drugs (proton pump inhibitors and antacids, etc.)、counter drugs、Chinese herbal medicines or food supplements that may affect the drug under the test within 1 months before the random;
- Subjects who have had any acute illness experience of clinical significance as determined by the investigator within 1 months before the screening;
- Subjects who have had smoked, drank alcohol, drank xanthine or caffeine-containing food and beverages, exercised vigorously, or had other factors affecting drug absorption, distribution, metabolism, and excretion within 2 days before the random；
- Hepatitis B surface antigen, hepatitis C antibody, HIV antibody, and syphilis antibody is checked positive person;
- Females during pregnancy or breastfeeding；
- Subjects who are not suitable for venous blood sampling collection；
- The investigator judges that the subject has a disease that affects drug absorption, distribution, metabolism and excretion or can reduce compliance（Cardiovascular, liver, kidney, digestive tract, immune, blood, endocrine, metabolic, cancer, psychoneurosis, etc）；subjects may be in a situation or with a condition that, in the opinion of the investigator, would interfere with optimal participation in the study；
- Subjects who have had a risk factor for TVT or a family history (i.e., parent, sibling, or child) of short QT syndrome, long QT syndrome, unexplained sudden death, drowning, or infant syndrome in their youth (Less than/equal to age 40);
- Subjects who have had blood potassium, blood magnesium or blood calcium exceeds the normal range；
Trial locations and contacts
1 site in 1 country.
China1 site
Peking university Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: A Phase 1, Single-center, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Access the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food-effect of FCN-207 in Healthy Volunteers
This research study is studying an investigational drug called FCN-207 in healthy adult males or females.
Read the detailed description
This is a Phase 1, single-center, dose-escalations (SAD and MAD) and food effect study of FCN-207:
Part 1 Single Ascending Dose (SAD) study: randomized, double-blind, placebo-controlled.
Part 2 Food-effect study: single-dose, two-treatment (fasted vs. high-fat meal), two-sequence crossover design.
Part 3 Multiple Ascending Dose (MAD) study: randomized, double-blind, placebo-controlled.
- Conditions
- Hyperuricemia
- Being tested
- Placebo, fasted vs. high-fat meal
- Keywords
- hyperuricemia, single and multiple ascending doses, food effect
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
fasted vs. high-fat mealDietary supplement
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Single Ascending Dose (SAD) study | Placebo comparator | The single ascending dose trial set up 7 dose groups of 2.5, 5, 10, 20, 40, 60 and 80 mg. The 2.5 mg dose group was the exploratory part with open label, while the other dose groups were double-blind. 8 subjects were randomly enrolled in each dose group, 6 of whom received FCN-207 tablets and 2 of whom received placebo. This part of the study evaluated the safety, tolerability, and pharmacokinetic and pharmacodynamic studies of single dose FCN-207 tablets in healthy volunteers. Receives: Drug: Placebo |
| Part 2 Food-effect study | Experimental | Twelve subjects were enrolled and randomly divided into two groups. The subjects were given FCN-207 tablets after fasting and high-fat diet with double Cross experiment , and feces samples were collected for metabolism/excretion characteristics study. Receives: Dietary Supplement: fasted vs. high-fat meal |
| Part 3 Multiple Ascending Dose (MAD) study | Placebo comparator | A total of 16 subjects were randomly assigned to each dose group for multiple dose study , including 12 who received FCN-207 tablets and 4 who received placebo for a 10-day administration cycle. The dosage of multiple administration was based on the results of single ascending dose study results , and the method of drug administration refers to the results of the food influence test. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To quantify the occurrence of adverse events (AEs) reported in all subjects who received study drug
Incidence of untoward medical occurrences (adverse event = AE) in a participant who received study drug. Adverse events will be evaluated by dosing cohort and recorded according to NCI CTCAEv5 Common Toxicity Criteria
Measured: Up to week 4
To determine the occurrence of treatment-emergent adverse events (TEAs)
Incidence of untoward medical occurrences (adverse event = AE) attributed to study drug in a participant who received study drug. Adverse events will be evaluated and recorded by dosing cohort according to NCI CTCAEv5 Common Toxicity Criteria
Measured: Up to week 4
To determine the occurrence of treatment-related adverse events meeting the criteria for dose limiting toxicities (DLTs)
Incidence of the DLT population will consist all subjects who received the required amount of study drug during the DLT observation period (single ascending doses group：7 days ，multiple ascending doses：21 days) of study treatment . Treatment related AE is any untoward medical occurrence attributed to study drug in a participant that who received study drug. DLTs are adverse events meeting the protocol-specified criteria, evaluated and recorded according to NCI CTCAEv5 Common Toxicity Criteria will use medical terminology based on the Medical Dictionary for Regulatory Activities Terminology (MedDRA).
Measured: Up to week 4
Secondary outcomes (10)
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
Measured: 2 weeks
Pharmacokinetics (Cmax: Maximum plasma concentration)
Measured: 2 weeks
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
Measured: 2 weeks
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
Measured: 2 weeks
Pharmacokinetics (CL/F)
Measured: 2 weeks
Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
Measured: 2 weeks
Pharmacokinetics (λz：Elimination rate constant)
Measured: 2 weeks
Pharmacokinetics (DF)
Measured: 2 weeks
Pharmacokinetics (RCmax： Cmax accumulation multiple consecutive times)
Measured: 2 weeks
Pharmacokinetics (RAUC：AUC accumulation multiple consecutive times)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start11 Nov 2020
- Primary completion21 Dec 2021
- Study completion7 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fochon Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622124
- Sponsor's protocol ID
- FCN-207-PhⅠ-001
- Status last verified
- Nov 2021
- First submitted
- 15 Oct 2020
- Last updated
- 5 Aug 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 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-center, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Access the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food-effect of FCN-207 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04622124
- Acronym / sponsor ID
- FCN-207-PhⅠ-001
- Conditions
- Hyperuricemia
- Keywords
- hyperuricemia, single and multiple ascending doses, food effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Fochon Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 7 Jun 2022 (actual)
- First posted
- 9 Nov 2020 (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.
This research study is studying an investigational drug called FCN-207 in healthy adult males or females.
Detailed description
This is a Phase 1, single-center, dose-escalations (SAD and MAD) and food effect study of FCN-207:
Part 1 Single Ascending Dose (SAD) study: randomized, double-blind, placebo-controlled.
Part 2 Food-effect study: single-dose, two-treatment (fasted vs. high-fat meal), two-sequence crossover design.
Part 3 Multiple Ascending Dose (MAD) study: randomized, double-blind, placebo-controlled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 Single Ascending Dose (SAD) study | Placebo comparator | Drug: PlaceboThe single ascending dose trial set up 7 dose groups of 2.5, 5, 10, 20, 40, 60 and 80 mg. The 2.5 mg dose group was the exploratory part with open label, while the other dose groups were double-blind. 8 subjects were randomly enrolled in each dose group, 6 of whom received FCN-207 tablets and 2 of whom received placebo. This part of the study evaluated the safety, tolerability, and pharmacokinetic and pharmacodynamic studies of single dose FCN-207 tablets in healthy volunteers. |
| Part 2 Food-effect study | Experimental | Dietary Supplement: fasted vs. high-fat mealTwelve subjects were enrolled and randomly divided into two groups. The subjects were given FCN-207 tablets after fasting and high-fat diet with double Cross experiment , and feces samples were collected for metabolism/excretion characteristics study. |
| Part 3 Multiple Ascending Dose (MAD) study | Placebo comparator | Drug: PlaceboA total of 16 subjects were randomly assigned to each dose group for multiple dose study , including 12 who received FCN-207 tablets and 4 who received placebo for a 10-day administration cycle. The dosage of multiple administration was based on the results of single ascending dose study results , and the method of drug administration refers to the results of the food influence test. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female healthy subjects who were aged at 18 - 45 years；
- Weight ≥ 50 kg，Body Mass Index（BMI）＝ Weight（kg）/（Height）2（m2）， BMI at 19 - 28 kg/m2（Including boundary value）；
- No birth plan during the trial period and within 6 months after completion and are willing to use non-hormonal contraceptive measures;
- To understand the research procedure and method, voluntarily participate in the experiment and signed the informed consent；
Key exclusion criteria (20 listed)
- Blood uric acid < 4 mg/dL（240 μmol/L）or >7 mg/dL（420 μmol/L）；
- After inquiry and physical examination，subjects who have had cardiovascular, liver, kidney, gastrointestinal respiratory, neurological, mental, immune, blood, endocrine and metabolic diseases, or clinically significant symptoms/signs, or self-report the history of diseases；
- Physical examination（Height, weight, breathing, pulse, blood pressure, chest and abdominal examinations, etc）or the laboratory indexes [ Blood routine, urine routine, blood biochemistry ( including myocardial enzyme spectrum ), blood amylase and urine amylase, blood coagulation test, infectious disease screening, etc] were abnormal and have clinical significance；12-lead ECG、B-ultrasonography and chest radiograph is abnormal and have clinical significance.
- Subjects who have had a history of smoking (more than 5 cigarettes per day) and drinking alcohol (more than 15g of alcohol per day for women and more than 25g for men (15g is equivalent to 450ml of beer, 150ml of wine or 50ml of low-alcohol liquor), more than twice a week), and had a history of drug abuse;
- According to the investigator's judgment, the subject may be allergic to the test drug or any of its ingredients；
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 |
|---|---|---|
| Placebo | Drug | Part 1 Single Ascending Dose (SAD) study |
| fasted vs. high-fat meal | Dietary supplement | Part 2 Food-effect study |
| Placebo | Drug | Part 3 Multiple Ascending Dose (MAD) study |
Primary outcome
To quantify the occurrence of adverse events (AEs) reported in all subjects who received study drug
Time frame: Up to week 4
Incidence of untoward medical occurrences (adverse event = AE) in a participant who received study drug. Adverse events will be evaluated by dosing cohort and recorded according to NCI CTCAEv5 Common Toxicity Criteria
To determine the occurrence of treatment-emergent adverse events (TEAs)
Time frame: Up to week 4
Incidence of untoward medical occurrences (adverse event = AE) attributed to study drug in a participant who received study drug. Adverse events will be evaluated and recorded by dosing cohort according to NCI CTCAEv5 Common Toxicity Criteria
To determine the occurrence of treatment-related adverse events meeting the criteria for dose limiting toxicities (DLTs)
Time frame: Up to week 4
Incidence of the DLT population will consist all subjects who received the required amount of study drug during the DLT observation period (single ascending doses group：7 days ，multiple ascending doses：21 days) of study treatment . Treatment related AE is any untoward medical occurrence attributed to study drug in a participant that who received study drug. DLTs are adverse events meeting the protocol-specified criteria, evaluated and recorded according to NCI CTCAEv5 Common Toxicity Criteria will use medical terminology based on the Medical Dictionary for Regulatory Activities Terminology (MedDRA).
10 secondary outcomes
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
Time frame: 2 weeks
Pharmacokinetics (Cmax: Maximum plasma concentration)
Time frame: 2 weeks
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
Time frame: 2 weeks
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
Time frame: 2 weeks
Pharmacokinetics (CL/F)
Time frame: 2 weeks
Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
Time frame: 2 weeks
Pharmacokinetics (λz：Elimination rate constant)
Time frame: 2 weeks
Pharmacokinetics (DF)
Time frame: 2 weeks
Pharmacokinetics (RCmax： Cmax accumulation multiple consecutive times)
Time frame: 2 weeks
Pharmacokinetics (RAUC：AUC accumulation multiple consecutive times)
Time frame: 2 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 5 Aug 2024.
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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 fasted vs. high-fat meal in people with Hyperuricemia, run by Fochon Pharmaceuticals, 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 20 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 5 Aug 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. Some participants in this study may receive a placebo. 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?
To quantify the occurrence of adverse events (AEs) reported in all subjects who received study drug (time frame: Up to week 4). 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 5 Aug 2024.