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

NCT ID: NCT02374684

Last Updated: 2016-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-02-29

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Methosulide

Methosulide, oral administration

Group Type: EXPERIMENTAL

Methosulide

Intervention Type: DRUG

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)

Placebo

Placebo, oral administration

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo to match with experimental groups

Interventions

Methosulide

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)

Intervention Type: DRUG

Placebo

Placebo to match with experimental groups

Intervention Type: DRUG

Other Intervention Names

CM2010-01

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Academy Military Medical Science, China

INDUSTRY

Sponsor Role: collaborator

Hubei Biological Medicine Industrial Technology Institute Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ZHENG Heng

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Locations

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan，Hubei, , China

Countries

China

Other Identifiers

HubeiBMITI- CM2010-01-I

Identifier Type: -

Identifier Source: org_study_id