KCT0001742
Completed
未知
A Phase I Single-center, Randomized, Double-blind, Placebo-controlled Study in Healthy Volunteers to evaluate the Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses and Multiple Doses of SP-8203
Shin Poong Pharm0 sites72 target enrollmentTBD
ConditionsDiseases of the nervous system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the nervous system
- Sponsor
- Shin Poong Pharm
- Enrollment
- 72
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subject is male or female between the ages of 20 and 45 years, inclusive.
- •2\. Females must be non\-pregnant, non\-lactating, and practicing an acceptable method of birth control, or be surgically sterile or post\-menopausal. Non\-pregnancy will be confirmed by serum pregnancy tests conducted at Screening, CRU admission, and at the Follow\-Up Visit.
- •3\. Males must be agree to practice a medically acceptable method of birth control and will not donate sperm during the study.
- •4\. Subject’s body mass index (BMI) is \= 18 kg/m2 and \= 32 kg/m2, inclusive.
- •5\. Subject does not smoke and has not smoked or used nicotine\-containing products for at least 180 continuous days prior to the first dose.
- •6\. Subject has adequate venous access for repeated venipuncture.
- •7\. Subject has hemoglobin \= 11\.5 g/dL.
- •8\. Subject agrees to abstain from taking any dietary supplements or non\-prescription drugs (except for multi\-vitamins, or as otherwise authorized by the Investigator and Medical Monitor) for 14 days prior to CRU admission through discharge.
- •9\. Subject agrees to abstain from consuming alcohol\-containing beverages for 3 days prior to CRU admission through discharge.
- •10\. Subject agrees to abstain from consuming caffeine\- or chocolate\-containing products from CRU admission through discharge.
Exclusion Criteria
- •1\. Subject has a history or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
- •2\. Subject has a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically important idiosyncratic reaction to any drug.
- •3\. Subject has a predisposing condition that could interfere with the distribution, metabolism, or excretion of drugs or any condition that may confound the Pharmacokinetics(PK) analyses.
- •4\. Subject tests positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C virus.
- •5\. Subjects that have chronic QT prolongation syndrome (i.e. QTc \> 450 ms for males and \> 470 ms for females) in repeated Electrocardiography(EKG) measurements.
- •6\. Subject used any drugs or substances known to inhibit or induce cytochrome P450 2D6 (CYP) enzymes within 28 days prior to the first dose and throughout the study.
- •7\. Subject has a recent (2\-year) history of alcoholism or drug abuse.
- •8\. Subject tests positive for alcohol or drugs of abuse at the Screening Visit or upon admission to the CRU.
- •9\. Subject has been on a special diet during the 28 days prior to the first dose (eg, Atkins, South Beach, or any other high protein / high fat diets).
- •10\. Subject reports difficulty fasting or consuming standardized meals.
Outcomes
Primary Outcomes
Not specified
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