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

NCT02374684 | Completed Phase 1 DMC

• 1 other identifier: HubeiBMITI- CM2010-01-I
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Anti-Inflammatory Agents, Non-Steroidal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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

Study Arms (2)

Methosulide

EXPERIMENTAL

Methosulide, oral administration

Drug: Methosulide

Placebo

PLACEBO COMPARATOR

Placebo, oral administration

Drug: Placebo

Interventions

Methosulide 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)

Also known as: CM2010-01

Methosulide

Placebo DRUG

Placebo to match with experimental groups

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hubei Biological Medicine Industrial Technology Institute Co., Ltd.: lead
• Academy Military Medical Science, China: collaborator

Study Sites (1)

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

Wuhan，Hubei, China

Location

Study Officials

• ZHENG Heng

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: March 2, 2015
• Study Start: February 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 19, 2016

Record last verified: 2015-11

Locations

CN (1)