Food Effect Study of DDO-3055 Tablets in Healthy Subjects

Anemia in Chronic Kidney Disease Clinical Trial

Official title:

Food Effect Study of DDO-3055 Tablets in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04197778
• Other study ID #: DDO-3055-102
• Status: Completed
• Phase: Phase 1
• Start date: January 6, 2020
• Est. completion date: January 18, 2020

Study information

• Verified date: June 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 18, 2020
• Est. primary completion date: January 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia in Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• DDO-3055 tablet
DDO-3055 tablet, 2 single doses separated by 6 days.

Locations

Country	Name	City	State
China	Fuwai Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration-time curve (AUC) of DDO-3055		up to 2 days
Primary	Maximum plasma concentration (Cmax) of DDO-3055		up to 2 days
Primary	Time to maximum observed serum concentration (Tmax) of DDO-3055		up to 2 days
Primary	Terminal elimination half-life (T1/2) of DDO-3055		up to 2 days
Primary	Apparent total clearance of the drug from plasma after oral administration (CL/F) of DDO-3055		up to 2 days
Primary	Apparent volume of distribution after oral administration (V/F) of DDO-3055		up to 2 days
Secondary	Change of endogenous erythropoietin from baseline		up to 2 days
Secondary	Safety and tolerability	Use the incidence and severity of adverse events to assess safety and tolerability	up to 9 days