- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02333318
A Single Ascending Dose Escalation to Investigate Safety and PK of VVZ-149 Injection in Healthy Older Male Volunteers
March 11, 2019 updated by: Vivozon, Inc.
A Single Ascending Dose Escalation Clinical Trial to Investigate Safety and Pharmacokinetics of VVZ-149 Injection in Healthy Older Male Volunteers
The objective of this study is to investigate the safety, tolerability and pharmacokinetics (PK) of VVZ-149 injection after a single dose or loading/maintenance dose in healthy older male volunteers.
Study Overview
Detailed Description
VVZ-149 injection, an investigational product (IP) in this clinical study, is a multi-target analgesic drug candidate against glycine transporter type II (GlyT2) and serotonin receptor 2A (5HT2A).
The target receptors have been known to play important roles in the induction and transmission of pain signals in the pain-related neural system.
There have been efforts to develop new drugs that selectively antagonize the GlyT2 or 5HT2A, but it was unsuccessful due to limitations of single-target drugs.
VVZ-149 showed morphine-comparable analgesic and gabapentin-comparable anti-allodynic effects in various rat models of pain.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Subjects who voluntarily agree to participate and sign an IRB-approved informed consent form (ICF) prior to receiving any of the screening procedures
- Healthy male subjects aged between 50-84, inclusive at screening (the subjects aged 65 years or over can participate only in the single dose trial)
- Subjects with body weights between 50-90 kg, inclusive and with body mass index (BMI) between 18.0-29.9 kg/m2, inclusive
- Healthy subjects satisfying eligibility at screening (medical histories, physical examination, vital sign, electrocardiogram (ECG), hematology, clinical chemistry and urinalysis)
- Subjects who willing to use an medicinal allowed method of contraception or sterility during the study period
Exclusion Criteria:
- Subjects who have a presence or history of clinically significant hepatic, renal, neurologic, immunologic, pulmonary, endocrine, hematological, neoplastic, cardiovascular or psychiatric (e.g. mood disorders or obsessive-compulsive disorder) diseases (subjects with currently well-controlled conditions including hypertension, hyperlipidemia, arthritis, prostatic hypertrophy and cataracts may allow to participate at the discretion of the investigator.)
- Subjects with chronic infection or meaningful acute infection
- Subjects who have a history of clinically significant hypersensitivities or hypersensitivities to the ingredient of same family with IP and other drug (e.g. aspirin and antibiotics)
- Subjects who have a family history of chronic pain or with a first-degree relative with chronic pain
- Subjects who have a clinically significant ECG abnormalities or QTc interval >450 ms
Subjects who meet the following criteria at screening:
- AST or ALT level > 3 times the upper limit of the normal range
- Calculated eGFR by MDRD equation < 60 ml/min
- Platelets ≤ 75,000/mm3, Hemoglobin ≤ 9 g/dL, Neutrophils absolute ≤ 1000/mm3
Subjects who show the following vital signs at the screening:
- Systolic Blood Pressure (SBP): <92 mmHg or >160 mmHg
- Diastolic Blood Pressure (DBP): <50 mmHg or >95 mmHg
- Subjects who have a history of drug abuse or a positive urine screening for drug abuse
- Subjects who have taken any prescribed or herbal medicine within one week before the first administration of the IP or any non-prescribed medicine or vitamin supplement within three days before the first administration of the IP (if all other conditions are satisfied, these subjects may be eligible for the trial as judged by the investigator)
- Subjects who have participated in any other clinical trial within two months before the first administration of the IP
- Subjects who have donated a unit of whole blood within two months or blood components within one month before the first administration of the IP, or who have received blood transfusion within one month before the first administration of the IP
- Subjects who consume more than 21 units of alcohol per week (1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking throughout the trial
- Smokers who consume more than average of 10 cigarettes per day over the past three months or who are unable to abstain from smoking throughout the trial
- Subjects who consume or are unable to abstain from products containing caffeine (e.g. coffee, green tea, black tea and sodas) within 24 hours before the first administration of the IP and until discharge from the hospital
- Subjects judged ineligible for the study by the investigator for reasons of medical, psychological, social and geographical conditions causing poor study compliance
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Dose_VVZ-149 injection
|
Colorless, transparent liquid in water for injection
Other Names:
|
Experimental: Loading/Maintenance_VVZ-149 injection
|
Colorless, transparent liquid in water for injection
Other Names:
|
Placebo Comparator: Loading/Maintenance_Placebo
|
water for injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose-limiting toxicity and maximum tolerated dose
Time Frame: 8 day
|
Any Common Toxicity Criteria for Adverse Effects grade 3 or more adverse event , All significant toxicity judged by the investigator
|
8 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and Tolerability as measured by Adverse event, physical examination, vital signs, 12-lead ECG, consecutive ECG, SpO2 monitoring and Clinical laboratory.
Time Frame: 8 day
|
Adverse event, physical examination, vital signs, 12-lead ECG, consecutive ECG, SpO2 monitoring, Clinical laboratory
|
8 day
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The pharmacokinetics parameters: AUClast, AUCinf and Cmax
Time Frame: [Single Dose Trial] * Blood sampling (17 times) pre-dose and 0.25, 0.5, 1, 2, 3, 4, 4.25, 4.5, 5, 5.5, 6, 7, 8, 12, 24 and 32 h post-dose * Urine collection (5 times) pre-dose and 0-6, 6-12, 12-24 and 24-32 h post-dose [Loading/maintenance Dose Trial] *
|
Blood sampling and urine sampling
|
[Single Dose Trial] * Blood sampling (17 times) pre-dose and 0.25, 0.5, 1, 2, 3, 4, 4.25, 4.5, 5, 5.5, 6, 7, 8, 12, 24 and 32 h post-dose * Urine collection (5 times) pre-dose and 0-6, 6-12, 12-24 and 24-32 h post-dose [Loading/maintenance Dose Trial] *
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jae Yong Chung, MD, PhD, Seoul National University Bundang Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
December 24, 2014
First Submitted That Met QC Criteria
January 5, 2015
First Posted (Estimate)
January 7, 2015
Study Record Updates
Last Update Posted (Actual)
March 13, 2019
Last Update Submitted That Met QC Criteria
March 11, 2019
Last Verified
January 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- PT-VVZ149-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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