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CompletedNCT01469910Updated Jul 10, 2012

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

A Phase 1 interventional study of Simotinib Hydrochloride and Placebo in Healthy, sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-10.

Sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd. is the lead sponsor of 75 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    Simotinib

    Drug: Simotinib Hydrochloride

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugSimotinib Hydrochloride

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

  • DrugPlacebo

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

06

What researchers measure

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

07

Study locations

1 site
  • The Third Xiangya Hospital of Central South University
    Changsha, Hunan 410013, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01469910
Lead sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Nov 10, 2011
Start date
Sep 2011
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Jul 10, 2012

Study contacts

Zeneng Cheng, MD
principal investigator · The Third Xiangya Hospital of Central South University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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