Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of Simotinib Hydrochloride in Healthy Subjects
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the safety and pharmacokinetics of single ascending doses of Simotinib Hydrochloride in healthy subjects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- The incidence and severity of adverse events [within 7 days following administration of study drug]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy , male or female subjects
-
Age of 18 to 45 years
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Body Mass Index (BMI) of 19 to 24 kg/m2; and a total body weight > 50 kg for male, > 45 kg for female
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Written informed consent signed and dated by the subject
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Subjects who are willing and able to comply with study procedures
Exclusion Criteria:
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Any clinically significant disease or surgery within 4 weeks prior to the beginning of the study
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Known hypersensitivity to the study drug or similar drugs
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History of any serious disease, including but not limited to circulatory system, endocrine system, central nervous system, hematology, immunology, metabolic diseases and psychiatric disorders
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History of gastrointestinal, hepatic, and renal diseases, affecting drug absorption and metabolism
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Any clinically significant abnormal clinical laboratory tests
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Abnormal ECG or vital signs
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A positive test for HIV antibody
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A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result
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History of alcohol consumption within six months of the study defined as: an average weekly intake of > 14 units
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History of regular tobacco use or nicotine containing products within three months prior to screening
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Consumption of too much tea or coffee (> 8 cups/day)
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Use of any drug, which inhibits or induces hepatic drug metabolism, within 30 days prior to the beginning of the study
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Use of any drug within 14 days prior to the beginning of the study
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Participate in other clinical trials within 30 days prior to the beginning of the study
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Blood donation within 30 days of dosing
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All female subjects must not be of child-bearing potential
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Pregnant or lactating women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SIM-101