Clinical Trial of Safety and Pharmacokinetics of VM-1500 After Multiple Oral Administration in Healthy Volunteers
Primary Purpose
HIV-infection
Status
Completed
Phase
Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
VM-1500
Placebo
Sponsored by

About this trial
This is an interventional treatment trial for HIV-infection
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Central Clinical City Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
10 mg VM-1500 or Placebo
20 mg VM-1500 or Placebo
30 mg VM-1500 or Placebo
Arm Description
VM-1500 for 9 volunteers, Placebo for 3 volunteers.
VM-1500 for 9 volunteers, Placebo for 3 volunteers.
VM-1500 for 9 volunteers, Placebo for 3 volunteers.
Outcomes
Primary Outcome Measures
Safety and tolerability of VM-1500 after multiple oral administration in adult healthy subjects based on analysis of AEs and laboratory values.
Peak Plasma concentration (Cmax) of VM-1500 after multiple oral administration in adult healthy subjects.
Area under the plasma concentration(AUC) of VM-1500 after multiple oral administration in adult healthy subjects.
Plasma elimination half-life (T1/2) of VM-1500 after multiple oral administration in adult healthy subjects.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02489435
Brief Title
Clinical Trial of Safety and Pharmacokinetics of VM-1500 After Multiple Oral Administration in Healthy Volunteers
Official Title
Randomized, Double-blind, Placebo-controlled, Phase Ib Clinical Trial of Safety and Pharmacokinetics of VM-1500 After Multiple Oral Administration in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Viriom
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This is a randomized, double-blind, placebo-controlled, phase Ib study in healthy volunteers with dose escalation to identify the optimal dosing schedule of VM-1500.
A total of 36 subjects will be treated with the VM-1500 or placebo for 14 days with further follow-up for four weeks. Subjects will be randomized into 3 cohorts with 3:1 drug/placebo ratio:
Cohort 1 (n=12): 10 mg VM-1500 for 9 volunteers, Placebo for 3 volunteers; Cohort 2 (n=12): 20 mg VM-1500 for 9 volunteers, Placebo for 3 volunteers; Cohort 3 (n=12): 30 mg VM-1500 for 9 volunteers, Placebo for 3 volunteers; Decision to escalate to the next (higher) dose will be made by the Independent Safety Review Board (ISRB), established specifically for this study. ISRB will base its decision on both the safety data obtained during drug administration in each cohort and analysis of clinical and lab data obtained within the course of the study.
Study time lines:
Screening period - up to 30 days
Treatment period - 14 days dosing (Day 1-14)
2 hospitalizations: Day 1-3, Day 13-15
28 PK samples in plasma: Day1 - predose, 0,25; 0,5; 1; 1,5; 2; 3; 4; 8; 12 hours Day 3, Day 5, Day 7, Day 9, Day 11, Day 13 - before dosing Day 14 (feed condition) - before dosing, 0,5; 1; 2; 4; 8; 12h Day 16, Day 23, Day 30, Day 37, Day 44 PK in blood cells - Day 1 (predose, 4h, 8h), Day 3, 5,7, 9, 11, 13, 14
Post treatment follow-up period 30 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
10 mg VM-1500 or Placebo
Arm Type
Experimental
Arm Description
VM-1500 for 9 volunteers, Placebo for 3 volunteers.
Arm Title
20 mg VM-1500 or Placebo
Arm Type
Experimental
Arm Description
VM-1500 for 9 volunteers, Placebo for 3 volunteers.
Arm Title
30 mg VM-1500 or Placebo
Arm Type
Experimental
Arm Description
VM-1500 for 9 volunteers, Placebo for 3 volunteers.
Intervention Type
Drug
Intervention Name(s)
VM-1500
Intervention Description
VM-1500
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Safety and tolerability of VM-1500 after multiple oral administration in adult healthy subjects based on analysis of AEs and laboratory values.
Time Frame
14 days during drug administration plus follow-up for four weeks
Title
Peak Plasma concentration (Cmax) of VM-1500 after multiple oral administration in adult healthy subjects.
Time Frame
14 days during drug administration plus follow-up for four weeks
Title
Area under the plasma concentration(AUC) of VM-1500 after multiple oral administration in adult healthy subjects.
Time Frame
14 days during drug administration plus follow-up for four weeks
Title
Plasma elimination half-life (T1/2) of VM-1500 after multiple oral administration in adult healthy subjects.
Time Frame
14 days during drug administration plus follow-up for four weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Central Clinical City Hospital
City
Reutov
State/Province
Moscow region
ZIP/Postal Code
143964
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial of Safety and Pharmacokinetics of VM-1500 After Multiple Oral Administration in Healthy Volunteers
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