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This study is to evaluate the safety, tolerability, pharmacokinetics of DC371739 after a single-dose oral administration in healthy Chinese subjects, and to explore the maximum tolerated dose, also the pharmacokinetics of urine and feces.
This is a randomized, double-blind , placebo-controlled, single-dose study in 43 male healthy subjects assigned to one of the six dose groups (30mg、50mg、100mg、 200mg、400mg and 600mg). 30mg dose group is the pilot group with 3 subjects. Each of the other dose groups will include 8 subjects (7 for DC371739 and 1 for placebo). Subjects will be admitted for treatment on day -1 and receive a single dose of study drug or placebo on day 1. Subjects from different dose groups were enrolled in turn, the next dose group was conducted on the premise that the D6 safety evaluation was completed after the administration of the previous dose group with the result was tolerance. Blood samples will be collected for each group after administration for pharmacokinetic data analysis. Urine and feces were collected in three dose groups of 100 mg, 200 mg and 400 mg respectively to explore the pharmacokinetic characteristics of urine and feces.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DC371739 100mg | Experimental | Single dose of 100 mg tablet orally administered |
|
| Placebo | Placebo Comparator | Placebo orally administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC371739 | Drug | Participants received one of 6 dose levels of DC371739 administered as single oral doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | The relationship of each adverse event to the investigational product was assessed by the investigator.A serious adverse event (SAE) is defined as an adverse event that is fatal is life threatening (places the subject at immediate risk of death) requires in-patient hospitalization or prolongation of existing hospitalization results in persistent or significant disability/incapacity other significant medical hazard. | From the first dose of study drug until Day 15 in three arms |
| Total urine excretion rate | Urine samples will be taken at different time points for analysis in three arms | From the first dose of study drug until Day 6 |
| Total feces excretion rate | feces samples will be taken at different time points for analysis in three arms | From the first dose of study drug until Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC(0-t)) | Blood samples will be taken at different time points before and after administration. | From the first dose of study drug until Day 6 |
| Time to reach maximum plasma concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Song Ai yun, Phd.MD. | Guang zhou JOYO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xu hui Central Hospital | Shanghai | Shanghai Municipality | 200031 | China |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Parallel Assignment
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| Placebo | Drug | Placebo orally administered |
|
Blood samples will be taken at different time points before and after administration.
| From the first dose of study drug until Day 6 |