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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02489435
• Other study ID #: 02/HIV/2010
• Status: Completed
• Phase: Phase 1
• First received: June 18, 2015
• Last updated: June 30, 2015
• Start date: July 2012
• Est. completion date: June 2013

Study information

• Verified date: June 2015
• Source: Viriom
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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 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

Intervention

Drug:
• VM-1500
VM-1500
• Placebo
Placebo

Locations

Country	Name	City	State
Russian Federation	Central Clinical City Hospital	Reutov	Moscow region

Sponsors (1)

Lead Sponsor	Collaborator
Viriom

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Primary	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	No
Primary	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	No