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This research study is studying an investigational drug called FCN-207 in healthy adult males or females.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
| ||
| fasted vs. high-fat meal |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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). | Up to week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (AUC: Area under the plasma concentration-time curve) | 2 weeks | |
| Pharmacokinetics (Cmax: Maximum plasma concentration) | 2 weeks | |
| Pharmacokinetics (Tmax: Time to reach the peak plasma concentration) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics(CFE:Cumulative fecal excretion) | At week1, 2, 3 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking university Third Hospital | Beijing | Beijing Municipality | 100191 | China |
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| ID | Term |
|---|---|
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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double-blind
| Dietary Supplement |
|
| Placebo | Drug |
|
| 2 weeks |
| Pharmacokinetics (T1/2: Elimination half-life of plasma concentration) | 2 weeks |
| Pharmacokinetics (CL/F) | 2 weeks |
| Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed) | 2 weeks |
| Pharmacokinetics (λz:Elimination rate constant) | 2 weeks |
| Pharmacokinetics (DF) | 2 weeks |
| Pharmacokinetics (RCmax: Cmax accumulation multiple consecutive times) | 2 weeks |
| Pharmacokinetics (RAUC:AUC accumulation multiple consecutive times) | 2 weeks |