Skip to main content
OpenTrials
Completed

NCT Number: NCT01469910

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simotinib Hydrochloride

Drug

Single ascending doses: 25 mg、50 mg、100 mg、150 mg、225 mg、300 mg、400 mg、500 mg、600 mg、750 mg

Placebo

Drug

Single ascending doses: 150 mg、225 mg、300 mg、400 mg、500 mg、600 mg、750 mg

Primary outcomes

  1. The incidence and severity of adverse events

    Time frame: within 7 days following administration of study drug

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 10, 2011
Registry last updated
Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.