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Completed

NCT Number: NCT02374684

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

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Wuhan,Hubei, China

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Other names: CM2010-01

Placebo

Drug

Placebo to match with experimental groups

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.

    Time frame: Period I: single dose,Baseline - 7 Days;Period II: repeated dose,Baseline - 14 Days

    Adverse events, vital signs, electrocardiograms, physical exams, and clinical laboratory assessments will be assessed prior to, during, and after treatment

Secondary outcomes

  1. Cmax of single oral administration of Methosulide and effect of food in healthy adults.

    Time frame: Baseline - 7 Days

  2. Tmax of single oral administration of Methosulide and effect of food in healthy adults.

    Time frame: Baseline - 7 Days

  3. area under curve(AUC) of single oral administration of Methosulide and effect of food in healthy adults.

    Time frame: Baseline - 7 Days

  4. t1/2α of single oral administration of Methosulide and effect of food in healthy adults.

    Time frame: Baseline - 7 Days

  5. t1/2β of single oral administration of Methosulide and effect of food in healthy adults.

    Time frame: Baseline - 7 Days

  6. Vd of single oral administration of Methosulide and effect of food in healthy adults.

    Time frame: Baseline - 7 Days

  7. Cls of single oral administration of Methosulide and effect of food in healthy adults.

    Time frame: Baseline - 7 Days

  8. Css of repeated oral administration of Methosulide in healthy adults.

    Time frame: Baseline - 14 Days

  9. Cmax of repeated oral administration of Methosulide in healthy adults.

    Time frame: Baseline - 14 Days

  10. Tmax of repeated oral administration of Methosulide in healthy adults.

    Time frame: Baseline - 14 Days

  11. area under curve(AUC) of repeated oral administration of Methosulide in healthy adults.

    Time frame: Baseline - 14 Days

  12. t1/2α of repeated oral administration of Methosulide in healthy adults.

    Time frame: Baseline - 14 Days

  13. t1/2β of repeated oral administration of Methosulide in healthy adults.

    Time frame: Baseline - 14 Days

  14. Vd of repeated oral administration of Methosulide in healthy adults.

    Time frame: Baseline - 14 Days

  15. Cls of repeated oral administration of Methosulide in healthy adults.

    Time frame: Baseline - 14 Days

Sponsors and collaborators

Lead sponsor

Hubei Biological Medicine Industrial Technology Institute Co., Ltd.

Other

Collaborators

  • Academy Military Medical Science, China

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 2, 2015
Registry last updated
Feb 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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