Back to resultsAscending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of DC371739 Single-Dose Treatment in Healthy Subjects
Primary Purpose
Hyperlipidemia
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
DC371739
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyperlipidemia focused on measuring Hyperlipidemia
Eligibility Criteria
Inclusion Criteria:
- Aged 18-40 years, inclusive, male;
- Weight≥50kg; body mass index of 19 to 26 kg/m2, inclusive;
- Based on the medical history, physical examination, clinical laboratory examination, 12-lead ECG and vital signs results, subjects with no evidence of active or chronic diseases, or clinically significant abnormalities;
Exclusion Criteria:
- Subjects with a history of allergy to study drug ingredients or similar drug, with a history of allergic disease or allergic constitution
- Presence of symptoms or related history of any major disease, including but not limited to heart, liver, kidney diseases or other acute and chronic digestive tract diseases, respiratory diseases, bone and joint diseases, as well as blood, endocrine, nerve, mental and other systemic disease, or any other diseases or physiological conditions that could interfere with the results;
- Any surgical condition or condition that may significantly affect the metabolism and excretion of drug absorption and distribution, or that may pose a hazard to the subjects participating in the study; Any surgical condition or condition that may significantly affect the absorption, distribution, metabolism, and excretion of the study drug, or any surgical condition or condition that may harm to the subjects participating in the study;
- Subjects who donated blood or lost 400 ml of blood within 3 months prior to screening;
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Shanghai Xu hui Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DC371739 100mg
Placebo
Arm Description
Single dose of 100 mg tablet orally administered
Placebo orally administered
Outcomes
Primary Outcome Measures
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.
Total urine excretion rate
Urine samples will be taken at different time points for analysis in three arms
Total feces excretion rate
feces samples will be taken at different time points for analysis in three arms
Secondary Outcome Measures
Area under the plasma concentration versus time curve (AUC(0-t))
Blood samples will be taken at different time points before and after administration.
Time to reach maximum plasma concentration (Tmax)
Blood samples will be taken at different time points before and after administration.
Full Information
NCT ID
NCT04640012
First Posted
November 17, 2020
Last Updated
March 15, 2022
Sponsor
Guangzhou JOYO Pharma Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04640012
Brief Title
Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of DC371739 Single-Dose Treatment in Healthy Subjects
Official Title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of DC371739 Single-Dose Treatment in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 25, 2020 (Actual)
Primary Completion Date
March 19, 2021 (Actual)
Study Completion Date
March 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangzhou JOYO Pharma Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
Keywords
Hyperlipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DC371739 100mg
Arm Type
Experimental
Arm Description
Single dose of 100 mg tablet orally administered
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo orally administered
Intervention Type
Drug
Intervention Name(s)
DC371739
Intervention Description
Participants received one of 6 dose levels of DC371739 administered as single oral doses.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo orally administered
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
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.
Time Frame
From the first dose of study drug until Day 15 in three arms
Title
Total urine excretion rate
Description
Urine samples will be taken at different time points for analysis in three arms
Time Frame
From the first dose of study drug until Day 6
Title
Total feces excretion rate
Description
feces samples will be taken at different time points for analysis in three arms
Time Frame
From the first dose of study drug until Day 6
Secondary Outcome Measure Information:
Title
Area under the plasma concentration versus time curve (AUC(0-t))
Description
Blood samples will be taken at different time points before and after administration.
Time Frame
From the first dose of study drug until Day 6
Title
Time to reach maximum plasma concentration (Tmax)
Description
Blood samples will be taken at different time points before and after administration.
Time Frame
From the first dose of study drug until Day 6
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged 18-40 years, inclusive, male;
Weight≥50kg; body mass index of 19 to 26 kg/m2, inclusive;
Based on the medical history, physical examination, clinical laboratory examination, 12-lead ECG and vital signs results, subjects with no evidence of active or chronic diseases, or clinically significant abnormalities;
Exclusion Criteria:
Subjects with a history of allergy to study drug ingredients or similar drug, with a history of allergic disease or allergic constitution
Presence of symptoms or related history of any major disease, including but not limited to heart, liver, kidney diseases or other acute and chronic digestive tract diseases, respiratory diseases, bone and joint diseases, as well as blood, endocrine, nerve, mental and other systemic disease, or any other diseases or physiological conditions that could interfere with the results;
Any surgical condition or condition that may significantly affect the metabolism and excretion of drug absorption and distribution, or that may pose a hazard to the subjects participating in the study; Any surgical condition or condition that may significantly affect the absorption, distribution, metabolism, and excretion of the study drug, or any surgical condition or condition that may harm to the subjects participating in the study;
Subjects who donated blood or lost 400 ml of blood within 3 months prior to screening;
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Song Ai yun, Phd.MD.
Organizational Affiliation
Guang zhou JOYO Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Xu hui Central Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of DC371739 Single-Dose Treatment in Healthy Subjects
We'll reach out to this number within 24 hrs