Clinical trial NCT01469910: Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of Simotinib Hydrochloride in Healthy Subjects
Official title: Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of Simotinib Hydrochloride in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-11-10
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: The incidence and severity of adverse events
timeFrame: within 7 days following administration of study drug
Secondary outcomes:
measure: The maximum plasma concentration (Cmax)
timeFrame: 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
measure: The time to Cmax (tmax)
timeFrame: 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
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: 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
measure: The Terminal half-life (t1/2)
timeFrame: 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:
Locations:
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: The Third Xiangya Hospital of Central South University
name: Zeneng Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References: