Food Effect Study of DDO-3055 Tablets in Healthy Subjects

Phase 1

Completed

• Conditions: Anemia in Chronic Kidney Disease
• Interventions: Drug: DDO-3055 tablet

• Registration Number: NCT04197778
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-11
• Study First Posted: 2019-12-13
• Study Start: 2020-01-06
• Primary Completion: 2020-01-18
• Study Completion: 2020-01-18
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-07
• Last Update Posted: 2022-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
group A	DDO-3055 tablet	-
group B	DDO-3055 tablet	-

Primary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax) of DDO-3055	up to 2 days
Terminal elimination half-life (T1/2) of DDO-3055	up to 2 days
Area under the concentration-time curve (AUC) of DDO-3055	up to 2 days
Time to maximum observed serum concentration (Tmax) of DDO-3055	up to 2 days
Apparent total clearance of the drug from plasma after oral administration (CL/F) of DDO-3055	up to 2 days
Apparent volume of distribution after oral administration (V/F) of DDO-3055	up to 2 days

Secondary Outcome Measures

Name	Time	Method
Change of endogenous erythropoietin from baseline	up to 2 days
Safety and tolerability	up to 9 days	Use the incidence and severity of adverse events to assess safety and tolerability

Trial Locations

Locations (1)

Fuwai Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China