Status:
COMPLETED
A Phase 1 Study to Evaluate PK Profile and Food Effects on PK Parameters of TNP-2092 Capsules
Lead Sponsor:
TenNor Therapeutics (Suzhou) Limited
Collaborating Sponsors:
The First Hospital of Jilin University
Conditions:
Hyperammonemia
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The aim of the study was to evaluate the tolerability and pharmacokinetic characteristics of TNP-2092 Capsules after single-dose administration in healthy subjects, and the food effect on pharmacokine...
Detailed Description
This was a single-center, randomized, double-blind, placebo-controlled, dose-ascending single-dose-administration study, and a study on the food effects on pharmacokinetics. Five dose groups of 100 mg...
Eligibility Criteria
Inclusion
- Sex: male or female;
- Age: 18-45 years, inclusive;
- BMI: 19.0-26.0 kg/m2, inclusive;
- Female subjects of childbearing potential must agree to practice abstinence or take effective contraceptive measures during the study and at least 70 days (10 weeks) after administration;
- Male subjects must agree to practice abstinence or use condoms as a contraceptive measure during the study and at least 70 days (10 weeks) after administration;
- Subjects whose clinical laboratory test results are within the normal range or whose test results are abnormal, but judged by the investigator to be of no clinical insignificance;
- Those who do not smoke, or have smoked less than 5 cigarettes per day within 3 months before screening; those who do not drink alcohol, or have drunk less than 14 units of alcohol per week (1 unit of alcohol = 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) within 6 months before screening; those who have not smoked or drunk alcohol within 48 hours before admission to the study site;
- Those who are fully informed of and understand this study, and have signed the Informed Consent Form;
- Those who are willing to follow and able to complete all the study procedures.
Exclusion
- Those with symptoms or medical history of cardiovascular, digestive, respiratory, urinary, neurological, blood, immune, endocrine system diseases or tumor, mental illness, or any situation which, in the opinion of the investigator, may threaten the safety of the subjects or affect the correctness of the study results;
- Pregnant or lactating women;
- Those whose blood pressure above 150/90 mmHg or below 85/55 mmHg (supine position);
- Those with regular use of any prescription/over-the-counter drugs, including vitamins, minerals, nutritional supplements or herbs, within 2 weeks before enrollment and during the study;
- Those who are HIV positive, syphilis positive, hepatitis B surface antigen positive, hepatitis C antibody positive, and/or with a positive drug urine test result;
- Those who have a history of alcohol or drug abuse in the past 10 years; Those with an allergic constitution, a history of allergic diseases or a history of drug allergy;
- Those who have had beverages or foods containing methylxanthine (coffee, tea, coke, chocolate and energy drinks), grapefruit (fruit juice) and alcohol within 48 hours (2 days) before the clinical study;
- Those who have taken any drug that changes the activity of liver enzymes within 28 days before taking the investigational product or during the study;
- Those who have donated blood within 3 months before enrollment;
- Those who have participated in any clinical studies within 3 months before enrollment;
- Those who are the staff of the study site directly affiliated to this study or are their immediate family members. Immediate family members are defined as spouses, parents, children or siblings, whether related by blood or legally adopted;
- Those who are employees of TenNor Therapeutics;
- Other circumstances deemed by the investigator to be unsuitable for the subject to participate in this study.
Key Trial Info
Start Date :
June 6 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2016
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT06178718
Start Date
June 6 2016
End Date
August 2 2016
Last Update
April 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Hospital of Jilin University
Changchun, Jilin, China