Safety, Tolerability, and Pharmacokinetics of Single Asce... | NCT01469910

Studies
Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of Simotinib Hydrochloride in Healthy Subjects

NCT01469910

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Jul 10, 2012Estimated

Enrollment

63Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Simotinib Hydrochloride
Placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Nov 7, 2011

First Submission Date that Met QC Criteria

Nov 8, 2011

First Posted Date

Nov 10, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2012

Last Update Posted Date

Jul 10, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Label	Type	Description	Intervention Names
Simotinib	Experimental		Drug: Simotinib Hydrochloride
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Simotinib Hydrochloride	Drug	Single ascending doses: 25 mg、50 mg、100 mg、150 mg、225 mg、300 mg、400 mg、500 mg、600 mg、750 mg	Simotinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence and severity of adverse events		within 7 days following administration of study drug

Secondary Outcomes

Measure	Description	Time Frame
The maximum plasma concentration (Cmax)		0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 16h, 24 h, 36 h, 48 h
The time to Cmax (tmax)		0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 16h, 24 h, 36 h, 48 h

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy , male or female subjects
Age of 18 to 45 years
Body Mass Index (BMI) of 19 to 24 kg/m2; and a total body weight > 50 kg for male, > 45 kg for female
Written informed consent signed and dated by the subject
Subjects who are willing and able to comply with study procedures

Exclusion Criteria:

Any clinically significant disease or surgery within 4 weeks prior to the beginning of the study
Known hypersensitivity to the study drug or similar drugs
History of any serious disease, including but not limited to circulatory system, endocrine system, central nervous system, hematology, immunology, metabolic diseases and psychiatric disorders
History of gastrointestinal, hepatic, and renal diseases, affecting drug absorption and metabolism
Any clinically significant abnormal clinical laboratory tests
Abnormal ECG or vital signs
A positive test for HIV antibody
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result
History of alcohol consumption within six months of the study defined as: an average weekly intake of > 14 units
History of regular tobacco use or nicotine containing products within three months prior to screening
Consumption of too much tea or coffee (> 8 cups/day)
Use of any drug, which inhibits or induces hepatic drug metabolism, within 30 days prior to the beginning of the study
Use of any drug within 14 days prior to the beginning of the study
Participate in other clinical trials within 30 days prior to the beginning of the study
Blood donation within 30 days of dosing
All female subjects must not be of child-bearing potential
Pregnant or lactating women

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided