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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: Simotinib Hydrochloride

• Registration Number: NCT01469910
• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-11-07
• Study First Submitted QC: 2011-11-08
• Study First Posted: 2011-11-10
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-09
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Simotinib	Simotinib Hydrochloride	-

Primary Outcome Measures

Name	Time	Method
The incidence and severity of adverse events	within 7 days following administration of study drug

Secondary Outcome Measures

Name	Time	Method
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
Area under the plasma concentration-time curve (AUC)	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 Terminal half-life (t1/2)	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

Trial Locations

Locations (1)

The Third Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China