Skip to main content
OpenTrials
Completed

NCT Number: NCT04197778

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DDO-3055 tablet

Drug

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

Primary outcomes

  1. Area under the concentration-time curve (AUC) of DDO-3055

    Time frame: up to 2 days

  2. Maximum plasma concentration (Cmax) of DDO-3055

    Time frame: up to 2 days

  3. Time to maximum observed serum concentration (Tmax) of DDO-3055

    Time frame: up to 2 days

  4. Terminal elimination half-life (T1/2) of DDO-3055

    Time frame: up to 2 days

  5. Apparent total clearance of the drug from plasma after oral administration (CL/F) of DDO-3055

    Time frame: up to 2 days

  6. Apparent volume of distribution after oral administration (V/F) of DDO-3055

    Time frame: up to 2 days

Secondary outcomes

  1. Change of endogenous erythropoietin from baseline

    Time frame: up to 2 days

  2. Safety and tolerability

    Time frame: up to 9 days

    Use the incidence and severity of adverse events to assess safety and tolerability

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 13, 2019
Registry last updated
Jun 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.