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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01469910
• Date of registration: 07/11/2011
• Primary sponsor: Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
• Public title: Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of Simotinib Hydrochloride in Healthy Subjects
• Scientific title: Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of Simotinib Hydrochloride in Healthy Subjects
• Date of first enrolment: September 2011
• Target sample size: 63
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01469910
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

China

Contacts

• Name: Zeneng Cheng, MD
• Affiliation: The Third Xiangya Hospital of Central South University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Placebo

Drug: Simotinib Hydrochloride

Primary Outcome(s)

The incidence and severity of adverse events [Time Frame: within 7 days following administration of study drug]

Secondary Outcome(s)

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]

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]

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]

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]

Secondary ID(s)

SIM-101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors