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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Simotinib Hydrochloride; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • The Third Xiangya Hospital of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Single ascending doses: 150 mg、225 mg、300 mg、400 mg、500 mg、600 mg、750 mg
Experimental: Simotinib	Drug: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Zeneng Cheng, MD, The Third Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: November 7, 2011
• First Submitted That Met QC Criteria: November 8, 2011
• First Posted (Estimate): November 10, 2011

Study Record Updates

• Last Update Posted (Estimate): July 10, 2012
• Last Update Submitted That Met QC Criteria: July 9, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: SIM-101