HealthyPhase 1NCT02374684
Tolerability, Safety and Pharmacokinetic Study Of Methosulide in Healthy Adult Subjects
A Phase 1 study testing Methosulide in people with Healthy, run by Hubei Biological Medicine Industrial Technology Institute Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Methosulide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- Feb 2015to Feb 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan，Hubei
About this study
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.
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.
Read the detailed description
- 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.
- Conditions
- Healthy
- Being tested
- Methosulide, Placebo
- Keywords
- Anti-Inflammatory Agents, Non-Steroidal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethosulideDrug
Also called CM2010-01
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)
PlaceboDrug
Placebo to match with experimental groups
| Study group | Role | What they receive |
|---|---|---|
| Methosulide | Experimental | Methosulide, oral administration Receives: Drug: Methosulide |
| Placebo | Placebo comparator | Placebo, oral administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline - 7 Days
Tmax of single oral administration of Methosulide and effect of food in healthy adults.
Measured: Baseline - 7 Days
area under curve(AUC) of single oral administration of Methosulide and effect of food in healthy adults.
Measured: Baseline - 7 Days
t1/2α of single oral administration of Methosulide and effect of food in healthy adults.
Measured: Baseline - 7 Days
t1/2β of single oral administration of Methosulide and effect of food in healthy adults.
Measured: Baseline - 7 Days
Vd of single oral administration of Methosulide and effect of food in healthy adults.
Measured: Baseline - 7 Days
Cls of single oral administration of Methosulide and effect of food in healthy adults.
Measured: Baseline - 7 Days
Css of repeated oral administration of Methosulide in healthy adults.
Measured: Baseline - 14 Days
Cmax of repeated oral administration of Methosulide in healthy adults.
Measured: Baseline - 14 Days
Tmax of repeated oral administration of Methosulide in healthy adults.
Measured: Baseline - 14 Days
area under curve(AUC) of repeated oral administration of Methosulide in healthy adults.
Measured: Baseline - 14 Days
t1/2α of repeated oral administration of Methosulide in healthy adults.
Measured: Baseline - 14 Days
t1/2β of repeated oral administration of Methosulide in healthy adults.
Measured: Baseline - 14 Days
Vd of repeated oral administration of Methosulide in healthy adults.
Measured: Baseline - 14 Days
Cls of repeated oral administration of Methosulide in healthy adults.
Measured: Baseline - 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hubei Biological Medicine Industrial Technology Institute Co., Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Academy Military Medical Science, China
- Responsible party
- Sponsor
- Investigators
- ZHENG Heng, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374684
- Sponsor's protocol ID
- HubeiBMITI- CM2010-01-I
- Status last verified
- Nov 2015
- First submitted
- 5 Feb 2015
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02374684
- Acronym / sponsor ID
- HubeiBMITI- CM2010-01-I
- Conditions
- Healthy
- Keywords
- Anti-Inflammatory Agents, Non-Steroidal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Hubei Biological Medicine Industrial Technology Institute Co., Ltd.University, hospital or other
- Collaborators
- Academy Military Medical Science, China
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methosulide | Experimental | Drug: MethosulideMethosulide, oral administration |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, oral administration |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethosulideAlso: CM2010-01Tolerability 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) | Drug | Methosulide |
| PlaceboPlacebo to match with experimental groups | Drug | Placebo |
Primary outcome
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
15 secondary outcomes
Cmax of single oral administration of Methosulide and effect of food in healthy adults.
Time frame: Baseline - 7 Days
Tmax of single oral administration of Methosulide and effect of food in healthy adults.
Time frame: Baseline - 7 Days
area under curve(AUC) of single oral administration of Methosulide and effect of food in healthy adults.
Time frame: Baseline - 7 Days
t1/2α of single oral administration of Methosulide and effect of food in healthy adults.
Time frame: Baseline - 7 Days
t1/2β of single oral administration of Methosulide and effect of food in healthy adults.
Time frame: Baseline - 7 Days
Vd of single oral administration of Methosulide and effect of food in healthy adults.
Time frame: Baseline - 7 Days
Cls of single oral administration of Methosulide and effect of food in healthy adults.
Time frame: Baseline - 7 Days
Css of repeated oral administration of Methosulide in healthy adults.
Time frame: Baseline - 14 Days
Cmax of repeated oral administration of Methosulide in healthy adults.
Time frame: Baseline - 14 Days
Tmax of repeated oral administration of Methosulide in healthy adults.
Time frame: Baseline - 14 Days
area under curve(AUC) of repeated oral administration of Methosulide in healthy adults.
Time frame: Baseline - 14 Days
t1/2α of repeated oral administration of Methosulide in healthy adults.
Time frame: Baseline - 14 Days
t1/2β of repeated oral administration of Methosulide in healthy adults.
Time frame: Baseline - 14 Days
Vd of repeated oral administration of Methosulide in healthy adults.
Time frame: Baseline - 14 Days
Cls of repeated oral administration of Methosulide in healthy adults.
Time frame: Baseline - 14 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ZHENG Heng principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Methosulide in people with Healthy, run by Hubei Biological Medicine Industrial Technology Institute Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Period I: single dose,Baseline - 7 Days;Period II: repeated dose,Baseline - 14 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016.