Food Effect Study of DDO-3055 Tablets in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Anemia in Chronic Kidney Disease
• Intervention / Treatment: Drug: DDO-3055 tablet

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Fuwai Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A	Drug: DDO-3055 tablet; DDO-3055 tablet, 2 single doses separated by 6 days.
Experimental: group B	Drug: DDO-3055 tablet; DDO-3055 tablet, 2 single doses separated by 6 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration-time curve (AUC) of DDO-3055	up to 2 days
Maximum plasma concentration (Cmax) of DDO-3055	up to 2 days
Time to maximum observed serum concentration (Tmax) of DDO-3055	up to 2 days
Terminal elimination half-life (T1/2) 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

Outcome Measure	Measure Description	Time Frame
Change of endogenous erythropoietin from baseline		up to 2 days
Safety and tolerability	Use the incidence and severity of adverse events to assess safety and tolerability	up to 9 days

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): January 18, 2020
• Study Completion (Actual): January 18, 2020

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 7, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: DDO-3055-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No