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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01469910
First received: November 7, 2011
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Simotinib Hydrochloride
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of Simotinib Hydrochloride in Healthy Subjects

Further study details as provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • The incidence and severity of adverse events [ Time Frame: within 7 days following administration of study drug ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The maximum plasma concentration (Cmax) [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • The time to Cmax (tmax) [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve (AUC) [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • The Terminal half-life (t1/2) [ Time Frame: 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 ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: September 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo Drug: Placebo
Single ascending doses: 150 mg、225 mg、300 mg、400 mg、500 mg、600 mg、750 mg

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01469910

Locations
China, Hunan
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013
Sponsors and Collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Zeneng Cheng, MD The Third Xiangya Hospital of Central South University
  More Information

No publications provided

Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01469910     History of Changes
Other Study ID Numbers: SIM-101
Study First Received: November 7, 2011
Last Updated: July 9, 2012
Health Authority: China: Food and Drug Administration

ClinicalTrials.gov processed this record on April 17, 2014