Clinical trial NCT02374684: Tolerability, Safety and Pharmacokinetic Study Of Methosulide in Healthy Adult Subjects
Official title: A Within-group Randomized, Double-Blind, Placebo-Controlled, Single/ Multiple Dose Study to Assess the Safety , Tolerability, Pharmacokinetics and Food Effect of Methosulide After Oral Administration In Healthy Adult Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Anti-Inflammatory Agents, Non-Steroidal
Lead sponsor: Hubei Biological Medicine Industrial Technology Institute Co., Ltd.
Sponsor class: OTHER
Collaborators: name: Academy Military Medical Science, China
First posted: 2015-03-02
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and tolerability, and to evaluate the pharmacokinetic characteristics and food effect of Methosulide after oral administration in healthy adult subjects.

Detailed description: 1. Dose-escalation study of single oral administration of Methosulide in healthy adults to assess the safety and tolerability.
2. Multiple-dose study of Methosulide in healthy adults to assess the safety and tolerability.
3. Dose-escalation study of single oral administration of Methosulide in healthy adults to evaluate the pharmacokinetic characteristics
4. Multiple-dose study of Methosulide in healthy adults to evaluate the pharmacokinetics characteristics
5. Single dose,and cross-over study of Methosulide in healthy adults to evaluate the pharmacokinetic characteristics and effect of food.

Eligibility criteria: Inclusion Criteria:

* Male or female, between 18 and 45 years of age, Body Mass Index (BMI) between 19～25 kg/m2, Weight \> or = 50kg
* In good health as judged by the investigator
* Without history of medication within 2 weeks before the test
* Non-allergic constitution, without known drug allergy
* Without history of major organ diseases
* Without other factors affecting drug metabolism, such as smoking (within 2 weeks), drinking (within 2 weeks), or drug abuse history
* Signed informed consent form and Fully understood the contents, process and possible adverse reactions of the test

Exclusion Criteria:

* History of kinds of food or drug allergy, or suffering from allergic diseases or allergic constitution
* Presence (in screening stage) or history of the acute/chronic organic diseases or clinical manifestations: blood system, renal disease, endocrine system, respiratory system, digestive system, cardiovascular system, nervous system, mental disease, allergic diseases (including drug allergy, but not including non-treatment, asymptomatic, seasonal allergy during the period of oral administration)
* History of abuse of Smoking, alcohol, or other drugs
* Severe hemorrhage factors to affect the venous blood collection
* Severe blood loss or blood donation within 3 months before the test
* Participation in other drug trials within 3 months before the test
* Usage of drugs known to have damage to the main organs within 3 months before the test
* Without good compliance, or unable to match with the test
* with a clinically significant abnormality in routine serological detection: including Hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infected
* For childbearing-aged women only, usage of any hormonal contraceptive methods within 3 months before the drug administration; or unable or unwilling to use non-hormonal contraceptive methods to contraception from the day of dosing until 14 days after dosing
* Be otherwise unsuitable for the study, in the opinion of the Investigator.

Primary outcomes:
measure: Safety and tolerability of single and repeated oral administration of Methosulide as measured by the frequency of drug-related clinical adverse events in healthy adults.
timeFrame: Period I: single dose,Baseline - 7 Days;Period II: repeated dose,Baseline - 14 Days
Secondary outcomes:
measure: Cmax of single oral administration of Methosulide and effect of food in healthy adults.
timeFrame: Baseline - 7 Days
measure: Tmax of single oral administration of Methosulide and effect of food in healthy adults.
timeFrame: Baseline - 7 Days
measure: area under curve(AUC) of single oral administration of Methosulide and effect of food in healthy adults.
timeFrame: Baseline - 7 Days
measure: t1/2α of single oral administration of Methosulide and effect of food in healthy adults.
timeFrame: Baseline - 7 Days
measure: t1/2β of single oral administration of Methosulide and effect of food in healthy adults.
timeFrame: Baseline - 7 Days
measure: Vd of single oral administration of Methosulide and effect of food in healthy adults.
timeFrame: Baseline - 7 Days
measure: Cls of single oral administration of Methosulide and effect of food in healthy adults.
timeFrame: Baseline - 7 Days
measure: Css of repeated oral administration of Methosulide in healthy adults.
timeFrame: Baseline - 14 Days
measure: Cmax of repeated oral administration of Methosulide in healthy adults.
timeFrame: Baseline - 14 Days
measure: Tmax of repeated oral administration of Methosulide in healthy adults.
timeFrame: Baseline - 14 Days
measure: area under curve(AUC) of repeated oral administration of Methosulide in healthy adults.
timeFrame: Baseline - 14 Days
measure: t1/2α of repeated oral administration of Methosulide in healthy adults.
timeFrame: Baseline - 14 Days
measure: t1/2β of repeated oral administration of Methosulide in healthy adults.
timeFrame: Baseline - 14 Days
measure: Vd of repeated oral administration of Methosulide in healthy adults.
timeFrame: Baseline - 14 Days
measure: Cls of repeated oral administration of Methosulide in healthy adults.
timeFrame: Baseline - 14 Days
Other outcomes:
Locations:
city: Wuhan，Hubei
country: China
facility: Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Study officials:
affiliation: Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology
name: ZHENG Heng
role: PRINCIPAL_INVESTIGATOR
References: