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

HIV-infection Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV-infection

• NCT number: NCT02489435
• Study type: Interventional
• Source: Viriom
• Status: Completed
• Phase: Phase 1
• Start date: July 2012
• Completion date: June 2013