Clinical Trials

MainTitle

Clinical Trial of Safety and Pharmacokinetics of VM-1500 After Multiple Oral Administration in Healthy Volunteers

This study has been completed
Sponsor
Viriom


Information provided by (Responsible Party)
Viriom
ClinicalTrials.gov Identifier
NCT02489435

First received: June 18, 2015
Last updated: June 30, 2015
Last Verified: June 2015
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV-infection

Drug : VM-1500
Drug : Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by Viriom:

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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 14 days during drug administration plus follow-up for four weeks ]

Enrollment: 36
Study Start Date: July 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: 10 mg VM-1500 or Placebo
VM-1500 for 9 volunteers, Placebo for 3 volunteers.
Drug: VM-1500

VM-1500

Drug: Placebo

Placebo

Experimental: 20 mg VM-1500 or Placebo
VM-1500 for 9 volunteers, Placebo for 3 volunteers.
Drug: VM-1500

VM-1500

Drug: Placebo

Placebo

Experimental: 30 mg VM-1500 or Placebo
VM-1500 for 9 volunteers, Placebo for 3 volunteers.
Drug: VM-1500

VM-1500

Drug: Placebo

Placebo

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
treatment follow-up period 30 days.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 50 Years  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: Yes  

Criteria

Inclusion Criteria:

    1. Provided signed written informed consent;
    2. Healthy male subjects, 18-50 years of age;
    3. Use of adequate and reliable forms of contraception during the study and 3 months after discontinuation of study medication.
    4. ICF signed prior to any study-related procedure.


Exclusion Criteria:
    1. HIV, hepatitis B, C antibodies in plasma;
    2. Clinical relevant laboratory abnormalities;
    3. Active tobacco, alcohol or drug abuse;
    4. Anticipated non-compliance with the protocol;
    5. Patients who have taken any investigational drug 3 months prior to the start of the study;
    6. Plasma donorship, surgery 12 weeks prior to the start of the study;
    7. Current significant gastrointestinal, renal, liver, bronchopulmonary, biliary,
    neurological, cardiovascular, oncologic, allergic, or ophthalmologic diseases, including history of cataracts/lens opacities.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02489435

Locations

Russian Federation
Central Clinical City Hospital
Reutov, Moscow region, Russian Federation, 143964

Sponsors and Collaborators

Viriom
More Information

More Information


Responsible Party: Viriom  
ClinicalTrials.gov Identifier: NCT02489435   History of Changes  
Other Study ID Numbers: 02/HIV/2010  
Study First Received: June 18, 2015  
Last Updated: June 30, 2015  

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.