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

NCT ID: NCT01469910

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-06-30

Brief Summary

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The purpose of this study is to assess the safety and pharmacokinetics of single ascending doses of Simotinib Hydrochloride in healthy subjects.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Simotinib

Group Type EXPERIMENTAL

Simotinib Hydrochloride

Intervention Type DRUG

Single ascending doses: 25 mg、50 mg、100 mg、150 mg、225 mg、300 mg、400 mg、500 mg、600 mg、750 mg

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single ascending doses: 150 mg、225 mg、300 mg、400 mg、500 mg、600 mg、750 mg

Interventions

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Simotinib Hydrochloride

Single ascending doses: 25 mg、50 mg、100 mg、150 mg、225 mg、300 mg、400 mg、500 mg、600 mg、750 mg

Intervention Type DRUG

Placebo

Single ascending doses: 150 mg、225 mg、300 mg、400 mg、500 mg、600 mg、750 mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jiangsu Simcere Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zeneng Cheng, MD

Role: PRINCIPAL_INVESTIGATOR

The Third Xiangya Hospital of Central South University

Locations

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The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status

Countries

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China

Other Identifiers

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SIM-101

Identifier Type: -

Identifier Source: org_study_id