Clinical trial NCT04197778: Food Effect Study of DDO-3055 Tablets in Healthy Subjects
Official title: Food Effect Study of DDO-3055 Tablets in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anemia in Chronic Kidney Disease
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-12-13
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Area under the concentration-time curve (AUC) of DDO-3055
timeFrame: up to 2 days
measure: Maximum plasma concentration (Cmax) of DDO-3055
timeFrame: up to 2 days
measure: Time to maximum observed serum concentration (Tmax) of DDO-3055
timeFrame: up to 2 days
measure: Terminal elimination half-life (T1/2) of DDO-3055
timeFrame: up to 2 days
measure: Apparent total clearance of the drug from plasma after oral administration (CL/F) of DDO-3055
timeFrame: up to 2 days
measure: Apparent volume of distribution after oral administration (V/F) of DDO-3055
timeFrame: up to 2 days
Secondary outcomes:
measure: Change of endogenous erythropoietin from baseline
timeFrame: up to 2 days
measure: Safety and tolerability
timeFrame: up to 9 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References: