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

NCT01469910 | Completed Phase 1

• 1 other identifier: SIM-101
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• The incidence and severity of adverse events

  within 7 days following administration of study drug

Secondary Outcomes (4)

• 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

Study Arms (2)

Simotinib

EXPERIMENTAL

Drug: Simotinib Hydrochloride

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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

Simotinib

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Study Officials

• Zeneng Cheng, MD

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: November 10, 2011
• Study Start: September 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

CN (1)