Back to resultsFood Effect Study of DDO-3055 Tablets in Healthy Subjects
Primary Purpose
Anemia in Chronic Kidney Disease
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
DDO-3055 tablet
Sponsored by
About this trial
This is an interventional other trial for Anemia in Chronic Kidney Disease
Eligibility Criteria
Inclusion Criteria:
- 1. Healthy male volunteers, aged 18~45.
- 2. Body weight ≥ 50 kg, body mass index (BMI) between 18 to 28.
- 3. Hemoglobin is in the normal range.
- 4. Signed informed consent.
Exclusion Criteria:
- 1. Vital signs, physical examination, laboratory results are abnormal and clinically significant.
- 2. Currently suffering from cardiovascular, liver, kidney, digestive, nervous, blood, thyroid or mental diseases.
- 3. Suspected allergy to the active ingredient or excipient of the experimental drug.
- 4. Have used erythropoietin within 1 month prior to screening or are currently using erythropoietin.
- 5. Had donated blood or blood transfusion within 3 months prior to screening.
- 6. Vein blood collection is difficult or physical condition can not afford blood collection.
- 7. Hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCVAb), Syphilis antibody, human immunodeficiency virus antibody (HIVAb)were positive.
- 8. Average daily smoking ≥5 cigarettes within 3 months before screening; average daily intake of alcohol within one week is more than 15g (15g alcohol is equivalent to 450mL beer or 150mL wine or 50mL low-alcohol liquor);or 2 days before taking the study drug and during the trial take the tobacco and alcohol and caffeinated foods or drinks, and have special dietary requirements and cannot follow a uniform diet.
- 9. 3 months prior to screening involved in any drug or medical device clinical trials, or within 5 half-life of drugs before screening.
- 10. Any health care products, Over-the-counter drugs or prescription drugs that affects the absorption, distribution, metabolism and excretion of the experimental drug was used within 1 month before the administration.
- 11. With a history of drug abuse or screening visit/baseline visit urine drug abuse screening positive.
- 12. Subjects who are unwilling to take contraceptives or who are likely to donate sperm during the trial and within 30 days after administration; or who do not agree to physical contraception during the trial.
- 13. Other conditions in which the study physician considered the subject not suitable for the trial.
Sites / Locations
- Fuwai Hospital, Chinese Academy of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
group A
group B
Arm Description
Outcomes
Primary Outcome Measures
Area under the concentration-time curve (AUC) of DDO-3055
Maximum plasma concentration (Cmax) of DDO-3055
Time to maximum observed serum concentration (Tmax) of DDO-3055
Terminal elimination half-life (T1/2) of DDO-3055
Apparent total clearance of the drug from plasma after oral administration (CL/F) of DDO-3055
Apparent volume of distribution after oral administration (V/F) of DDO-3055
Secondary Outcome Measures
Change of endogenous erythropoietin from baseline
Safety and tolerability
Use the incidence and severity of adverse events to assess safety and tolerability
Full Information
NCT ID
NCT04197778
First Posted
December 3, 2019
Last Updated
June 7, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04197778
Brief Title
Food Effect Study of DDO-3055 Tablets in Healthy Subjects
Official Title
Food Effect Study of DDO-3055 Tablets in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
January 18, 2020 (Actual)
Study Completion Date
January 18, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study is a randomized , open-label, two-stage crossover food effect study of single doses of DDO-3055 tablets in healthy subjects. 14 healthy subjects were randomly divided into groups A and B, 7 subjects in each group. Two stage washout period is 6 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia in Chronic Kidney Disease
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Experimental
Arm Title
group B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
DDO-3055 tablet
Intervention Description
DDO-3055 tablet, 2 single doses separated by 6 days.
Primary Outcome Measure Information:
Title
Area under the concentration-time curve (AUC) of DDO-3055
Time Frame
up to 2 days
Title
Maximum plasma concentration (Cmax) of DDO-3055
Time Frame
up to 2 days
Title
Time to maximum observed serum concentration (Tmax) of DDO-3055
Time Frame
up to 2 days
Title
Terminal elimination half-life (T1/2) of DDO-3055
Time Frame
up to 2 days
Title
Apparent total clearance of the drug from plasma after oral administration (CL/F) of DDO-3055
Time Frame
up to 2 days
Title
Apparent volume of distribution after oral administration (V/F) of DDO-3055
Time Frame
up to 2 days
Secondary Outcome Measure Information:
Title
Change of endogenous erythropoietin from baseline
Time Frame
up to 2 days
Title
Safety and tolerability
Description
Use the incidence and severity of adverse events to assess safety and tolerability
Time Frame
up to 9 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1. Healthy male volunteers, aged 18~45.
2. Body weight ≥ 50 kg, body mass index (BMI) between 18 to 28.
3. Hemoglobin is in the normal range.
4. Signed informed consent.
Exclusion Criteria:
1. Vital signs, physical examination, laboratory results are abnormal and clinically significant.
2. Currently suffering from cardiovascular, liver, kidney, digestive, nervous, blood, thyroid or mental diseases.
3. Suspected allergy to the active ingredient or excipient of the experimental drug.
4. Have used erythropoietin within 1 month prior to screening or are currently using erythropoietin.
5. Had donated blood or blood transfusion within 3 months prior to screening.
6. Vein blood collection is difficult or physical condition can not afford blood collection.
7. Hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCVAb), Syphilis antibody, human immunodeficiency virus antibody (HIVAb)were positive.
8. Average daily smoking ≥5 cigarettes within 3 months before screening; average daily intake of alcohol within one week is more than 15g (15g alcohol is equivalent to 450mL beer or 150mL wine or 50mL low-alcohol liquor);or 2 days before taking the study drug and during the trial take the tobacco and alcohol and caffeinated foods or drinks, and have special dietary requirements and cannot follow a uniform diet.
9. 3 months prior to screening involved in any drug or medical device clinical trials, or within 5 half-life of drugs before screening.
10. Any health care products, Over-the-counter drugs or prescription drugs that affects the absorption, distribution, metabolism and excretion of the experimental drug was used within 1 month before the administration.
11. With a history of drug abuse or screening visit/baseline visit urine drug abuse screening positive.
12. Subjects who are unwilling to take contraceptives or who are likely to donate sperm during the trial and within 30 days after administration; or who do not agree to physical contraception during the trial.
13. Other conditions in which the study physician considered the subject not suitable for the trial.
Facility Information:
Facility Name
Fuwai Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Food Effect Study of DDO-3055 Tablets in Healthy Subjects
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