Tolerability, Safety and Pharmacokinetic Study Of Methosulide in Healthy Adult Subjects

Study Overview
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Brief Summary
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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
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Dose-escalation study of single oral administration of Methosulide in healthy adults to assess the safety and tolerability. Multiple-dose study of Methosulide in healthy adults to assess the safety and tolerability. Dose-escalation study of single oral administration of Methosulide in healthy adults to evaluate the pharmacokinetic characteristics Multiple-dose study of Methosulide in healthy adults to evaluate the pharmacokinetics characteristics Single dose,and cross-over study of Methosulide in healthy adults to evaluate the pharmacokinetic characteristics and effect of food.

Official Title
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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.

Conditions
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Healthy

Intervention / Treatment
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* Drug: Methosulide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methosulide<br>Methosulide, oral administration | Drug: Methosulide<br>* Tolerability Study: Period I:Single oral administration,dose-escalation of Methosulide(six dose groups:25mg-250mg) Period II:Repeated oral administration of Methosulide(group 1:MTD（maximum tolerated dose）/250mg ,group 2:depending on the adverse drug reaction,150mg/250mg) Pharmacokinetic Study: Period I:Single oral administration,dose-escalation of Methosulide(three dose groups:50mg,100mg,200mg/250mg) Period II:Repeated oral administration of Methosulide(group 1:MTD（maximum tolerated dose）/250mg ,group 2:depending on the adverse drug reaction,150mg/250mg) Food Effect on the Pharmacokinetics: single dose(100mg),two status(Feeding and fasting), washout period(7 days)<br>* Other names: CM2010-01;|
| Placebo Comparator: Placebo<br>Placebo, oral administration | Drug: Placebo<br>* Placebo to match with experimental groups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Adverse events, vital signs, electrocardiograms, physical exams, and clinical laboratory assessments will be assessed prior to, during, and after treatment | Period I: single dose,Baseline - 7 Days;Period II: repeated dose,Baseline - 14 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of single oral administration of Methosulide and effect of food in healthy adults. |  | Baseline - 7 Days | 
| Tmax of single oral administration of Methosulide and effect of food in healthy adults. |  | Baseline - 7 Days | 
| area under curve(AUC) of single oral administration of Methosulide and effect of food in healthy adults. |  | Baseline - 7 Days | 
| t1/2α of single oral administration of Methosulide and effect of food in healthy adults. |  | Baseline - 7 Days | 
| t1/2β of single oral administration of Methosulide and effect of food in healthy adults. |  | Baseline - 7 Days | 
| Vd of single oral administration of Methosulide and effect of food in healthy adults. |  | Baseline - 7 Days | 
| Cls of single oral administration of Methosulide and effect of food in healthy adults. |  | Baseline - 7 Days | 
| Css of repeated oral administration of Methosulide in healthy adults. |  | Baseline - 14 Days | 
| Cmax of repeated oral administration of Methosulide in healthy adults. |  | Baseline - 14 Days | 
| Tmax of repeated oral administration of Methosulide in healthy adults. |  | Baseline - 14 Days | 
| area under curve(AUC) of repeated oral administration of Methosulide in healthy adults. |  | Baseline - 14 Days | 
| t1/2α of repeated oral administration of Methosulide in healthy adults. |  | Baseline - 14 Days | 
| t1/2β of repeated oral administration of Methosulide in healthy adults. |  | Baseline - 14 Days | 
| Vd of repeated oral administration of Methosulide in healthy adults. |  | Baseline - 14 Days | 
| Cls of repeated oral administration of Methosulide in healthy adults. |  | Baseline - 14 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti-Inflammatory Agents, Non-Steroidal