Clinical Trial of Safety and Pharmacokinetics of VM-1500 After Multiple Oral Administration in Healthy Volunteers
Randomized, Double-blind, Placebo-controlled, Phase Ib Clinical Trial of Safety and Pharmacokinetics of VM-1500 After Multiple Oral Administration in Healthy Volunteers
1 other identifier
interventional
36
1 country
1
Brief Summary
The purpose of the study to assess safety and tolerability of VM-1500 and to determine main pharmacokinetic parameters of VM-1500 after multiple oral administration in adult healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 18, 2015
CompletedFirst Posted
Study publicly available on registry
July 3, 2015
CompletedJuly 3, 2015
June 1, 2015
11 months
June 18, 2015
June 30, 2015
Conditions
Outcome Measures
Primary Outcomes (4)
Safety and tolerability of VM-1500 after multiple oral administration in adult healthy subjects based on analysis of AEs and laboratory values.
14 days during drug administration plus follow-up for four weeks
Peak Plasma concentration (Cmax) of VM-1500 after multiple oral administration in adult healthy subjects.
14 days during drug administration plus follow-up for four weeks
Area under the plasma concentration(AUC) of VM-1500 after multiple oral administration in adult healthy subjects.
14 days during drug administration plus follow-up for four weeks
Plasma elimination half-life (T1/2) of VM-1500 after multiple oral administration in adult healthy subjects.
14 days during drug administration plus follow-up for four weeks
Study Arms (3)
10 mg VM-1500 or Placebo
EXPERIMENTALVM-1500 for 9 volunteers, Placebo for 3 volunteers.
20 mg VM-1500 or Placebo
EXPERIMENTALVM-1500 for 9 volunteers, Placebo for 3 volunteers.
30 mg VM-1500 or Placebo
EXPERIMENTALVM-1500 for 9 volunteers, Placebo for 3 volunteers.
Interventions
Eligibility Criteria
You may qualify if:
- Provided signed written informed consent;
- Healthy male subjects, 18-50 years of age;
- Use of adequate and reliable forms of contraception during the study and 3 months after discontinuation of study medication.
- ICF signed prior to any study-related procedure.
You may not qualify if:
- HIV, hepatitis B, C antibodies in plasma;
- Clinical relevant laboratory abnormalities;
- Active tobacco, alcohol or drug abuse;
- Anticipated non-compliance with the protocol;
- Patients who have taken any investigational drug 3 months prior to the start of the study;
- Plasma donorship, surgery 12 weeks prior to the start of the study;
- Current significant gastrointestinal, renal, liver, bronchopulmonary, biliary, neurological, cardiovascular, oncologic, allergic, or ophthalmologic diseases, including history of cataracts/lens opacities.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Viriomlead
Study Sites (1)
Central Clinical City Hospital
Reutov, Moscow Oblast, 143964, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2015
First Posted
July 3, 2015
Study Start
July 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
July 3, 2015
Record last verified: 2015-06