Food Effect Study of DDO-3055 Tablets in Healthy Subjects

NCT04197778 | Completed Phase 1

• 1 other identifier: DDO-3055-102
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia in Chronic Kidney Disease

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Change of endogenous erythropoietin from baseline

  up to 2 days

• Safety and tolerability

  up to 9 days

Study Arms (2)

group A

EXPERIMENTAL

Drug: DDO-3055 tablet

group B

EXPERIMENTAL

Drug: DDO-3055 tablet

Interventions

DDO-3055 tablet DRUG

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

group A; group B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Healthy male volunteers, aged 18\~45.
• \. Body weight ≥ 50 kg, body mass index (BMI) between 18 to 28.
• \. Hemoglobin is in the normal range.
• \. Signed informed consent.

You may not qualify if:

• \. Vital signs, physical examination, laboratory results are abnormal and clinically significant.
• \. Currently suffering from cardiovascular, liver, kidney, digestive, nervous, blood, thyroid or mental diseases.
• \. Suspected allergy to the active ingredient or excipient of the experimental drug.
• \. Have used erythropoietin within 1 month prior to screening or are currently using erythropoietin.
• \. Had donated blood or blood transfusion within 3 months prior to screening.
• \. Vein blood collection is difficult or physical condition can not afford blood collection.
• \. Hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCVAb), Syphilis antibody, human immunodeficiency virus antibody (HIVAb)were positive.
• \. 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.
• \. 3 months prior to screening involved in any drug or medical device clinical trials, or within 5 half-life of drugs before screening.
• \. 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.
• \. With a history of drug abuse or screening visit/baseline visit urine drug abuse screening positive.
• \. 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.
• \. Other conditions in which the study physician considered the subject not suitable for the trial.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 13, 2019
• Study Start: January 6, 2020
• Primary Completion: January 18, 2020
• Study Completion: January 18, 2020
• Last Updated: June 8, 2022

Record last verified: 2022-06

Locations

CN (1)