Opioid-induced constipation
Conditions
Interventions
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy adult male or female subjects between 18 and 45 years of age (including threshold, subject to the date of signing the informed consent). 2. Body mass index (BMI = weight/height squared (kg/m2)) is 19~26 kg/m2 (including the critical value). The body weight of male subjects should not be less than 50 kg, and that of female subjects should not be less than 45 kg. 3. For subjects who have no pregnancy plan and voluntarily take effective contraceptive measures and have no sperm or egg donation plan from two weeks before screening to 6 months after the last administration for specific contraceptive measures; Female subjects should be non-lactating, have a negative pregnancy test, or have no fertility potential (women who have been menopausal for at least 12 months or who cannot become pregnant anatomically are considered to have no fertility potential). 4. Determine the health status of subjects through tests and diagnosis such as medical history, physical examination, vital signs, 12-lead electrocardiogram(12-lead ECG), etc. The results of clinical laboratory examination are normal, or the abnormality is judged to have no clinical significance by the investigator. 5. The subjects fully understand the purpose, nature, method and possible adverse reactions of the study, and voluntarily sign the informed consent form. 6. Be able to complete the test according to the program requirements.
Exclusion criteria
Exclusion criteria: 1. Subjects who are allergic to naldemedine and similar drugs. 2. Subjects who have difficulty in venous blood collection. 3. Subjects who have had a history of drug abuse in the past 5 years or used drugs(narcotics) in the 3 months before the trial, or are positive for drug abuse during the screening period or baseline period. 4. Subjects who smoked or consumed any nicotine-containing products from 24 weeks prior to the initial screening visit to admission. 5. Drinking more than 14 units of alcohol per week in the 6 months before screening (1 unit of alcohol = 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) or taking alcohol 48 hours before administration, or those who have a positive alcohol blood test during the screening period and/or baseline period. 6. Use of any medication known to be inhibitors (eg, itraconazole) or inducers (eg, rifampicin) of the cytochrome P450 drug-metabolizing system within 28 days prior to the start of screening. 7. Use of any prescription drugs, over-the-counter drugs, or herbal and health products within 14 days prior to the start of screening. 8. People who have taken food or drink (eg. grapefruit) containing enzymes that can induce or inhibit liver metabolism within 7 days before the start of screening. 9. Ingestion of any food or beverage (eg. coffee, tea, chocolate) that contains or is metabolized to produce caffeine or xanthine between 48 h before administration and the end of the study. 10. Any disease or history of clinical abnormalities, including but not limited to neurological, cardiovascular, blood, liver, kidney, gastrointestinal, respiratory, metabolic, endocrine, immunological, skeletal, or other factors, considered inappropriate for the study by the investigator. 11. Diagnose a history of chronic motor abnormalities (e.g., chronic constipation, chronic diarrhea, irritable bowel syndrome). 12. Human immunodeficiency virus (anti-HIV) antibody positive, hepatitis B surface antigen (HBsAg) positive, hepatitis C antibody (HCV-Ab) positive, treponema Pallidum antibody (anti-TP) positive. 13. Females who have a positive pregnancy test or are lactating during the screening or baseline period. 14. Subjects who have suffered from a major clinically significant disease or have undergone major surgery within 6 months before the administration, or are expected to undergo major surgery during the study period. 15. Subjects who have a history of surgery that affects digestive function such as gastrectomy, vagotomy, and enterectomy. 16. Four weeks before screening, or those who plan to be vaccinated with live (attenuated) vaccine during the study. 17. Acute illness and drug administration 2 weeks before screening. 18. Participate in other drug clinical studies within 3 months prior to initiation of administration. 19. Those with a history of blood donation or blood loss of more than 400 mL in 3 months prior to screening, or those who received blood transfusion within 8 weeks. 20. Those who have special requirements on diet and cannot accept unified diet. 21. Subjects who have participated in naldemedine (S-297995) trials and have received the study drug. 22. Any other circumstances, in the opinion of the investigator, that may affect the subject's informed consent or adherence to the protocol, or that the subject's participation in the study may affect the outcome of the study or their own safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters: Cmax [ng/mL];PK parameters: Tmax [h];PK parameters: t1/2,z [h];PK parameters: AUC [ng·h/mL];PK parameters: terminal elimination rate constant [?z: hr-1];PK parameters: apparent total clearance [CL/F: L/h];PK parameters: mean residence time [MRT: h];PK parameters: metabolic ratio of Cmax for metabolite to Cmax for naldemedine [MRCmax];PK parameters: metabolic ratio of AUC for metabolite to AUC for naldemedine [MRAUC]; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactWei Hu
The Second Hospital of Anhui Medical University
Outcome results
None listed