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

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.

Study Overview

• Status: Completed
• Conditions: HIV-infection
• Intervention / Treatment: Drug: Placebo; Drug: VM-1500

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10 mg VM-1500 or Placebo; VM-1500 for 9 volunteers, Placebo for 3 volunteers.	Drug: Placebo; Placebo; Drug: VM-1500; VM-1500
Experimental: 20 mg VM-1500 or Placebo; VM-1500 for 9 volunteers, Placebo for 3 volunteers.	Drug: Placebo; Placebo; Drug: VM-1500; VM-1500
Experimental: 30 mg VM-1500 or Placebo; VM-1500 for 9 volunteers, Placebo for 3 volunteers.	Drug: Placebo; Placebo; Drug: VM-1500; VM-1500

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Viriom

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: June 18, 2015
• First Submitted That Met QC Criteria: June 30, 2015
• First Posted (Estimate): July 3, 2015

Study Record Updates

• Last Update Posted (Estimate): July 3, 2015
• Last Update Submitted That Met QC Criteria: June 30, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: 02/HIV/2010