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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014