Status:
COMPLETED
Phase I Study to Investigate Safety, Tolerability, and Pharmacokinetics of VVZ-149 Injection
Lead Sponsor:
Vivozon, Inc.
Conditions:
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
VVZ-149 is a novel analgesic drug candidate that shows a potential analgesic activity inhibiting GlyT2 and 5HT2A simultaneously. There have been many efforts to develop single-target selective drugs t...
Detailed Description
In this clinical study, the investigational drug product will be offered as an injectable form in a transparent glass vial that contains VVZ-149 dissolved by water for injection. When administered, th...
Eligibility Criteria
Inclusion
- Subjects are eligible for the study if they met all the following
- willingness to sign the written informed consent form (ICF)
- 20\~45 years, inclusive, healthy male
- 50\~90kg, inclusive, and within the 20% of ideal body weight
- compatible at screening ( medical history, physical examination, vital signs, ECG, haematology, clinical chemistry, urinalysis)
- sterility or keep an ascetic life or male subjects and their female sexual partners had to use a following contraception method during the study period \*the medical contraception permissible method: condom, at least partner had to take the oral contraceptive over the 3 months or had to use the injection or insertion contraceptives, intrauterine device.
- Subjects are to be excluded from participation if any of the following
Exclusion
- Presence or history of diseases or abnormalities of liver, kidney, nervous system, respiratory system, endocrine system, or cardiovascular system. Presence or history of hemopathy or psychopathy (mood disorder, obsessive compulsive disorder etc.) Carrier of hepatitis virus in content of the liver disease, exclusive
- History of hypersensitivity reactions significant clinically or hypersensitivity reaction to the investigational product, the drugs containing identical ingredient, or other drugs (aspirin, antibiotic etc.)
- Family history of significant chronic pain disease or case of the immediate family (parent or brother) with chronic pain disease
- Electrocardiogram QTc \> 430 ms, PR interval \> 200 msec, QRS interval \> 120 msec, or any other clinically significant opinion at screening, exclusive
- Any of following results in the Clinical laboratory at screening, exclusive
- Exceed 1.25 times of the upper limit of the normal range of AST,AST
- Exceed 1.5 times of the upper limit of the normal range of BUN, Cr
- Out of normal range in Thyroid function (TSH, T4, FT4, T3) parameters
- Abnormal blood pressure (systolic \> 150 mmHg or \< 90 mmHg, diastolic \> 95 mmHg or \< 60 mmHg) in vital signs at screening, exclusive
- history of drug abuse, positive screen on the an alcohol breath test and an urine drug screening
- Taking any ETC or oriental medicine within 2 weeks prior to drug administration, taking any OTC or vitamins within a week prior to drug administration, (but could participate in the study if other conditions are considered appropriate by the medical investigator)
- Participation in a drug study (clinical trials) within 2 months prior to drug administration
- Donation of whole blood within 2 months or blood component within a month or receiving a blood transfusion within a month prior to drug administration
- Intake of more than 21 units per week (one unit of alcohol (10 g of pure alcohol) equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits), Unable to stop drinking during the study period
- A smoker (if case of non-smoker to stop smoking within 3 months prior to drug administration, they could participate in this study) and positive screen on urine cotinine test.
- Taking food and drink containing caffeine (coffee, tea, a carbonated drink, a coffee milk, and nutritious tonic etc) from 24 hours prior to hospitalization for clinical trial to discharge from hospital, Unable not to take them.
- judged inappropriate because of medical, psychological, social and geographical conditions difficult to participate in the study or difficult to follow the treatment compliance or follow-up guidelines.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01905410
Start Date
July 1 2013
End Date
April 1 2014
Last Update
March 13 2019
Active Locations (1)
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1
Seoul National University Bundang Hospital
Sungnam-Si, Gyeonggi-do, South Korea, 463-707