HIV-infectionPhase 1NCT02489435
Clinical Trial of Safety and Pharmacokinetics of VM-1500 After Multiple Oral Administration in Healthy Volunteers
A Phase 1 study testing VM-1500 in people with HIV-infection, run by Viriom at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV-infection
- What is being tested?
- VM-1500
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteRussia
- Study dates
- Jul 2012to Jun 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- HIV-infection
- Being tested
- VM-1500, Placebo
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VM-1500Drug
VM-1500
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 10 mg VM-1500 or Placebo | Experimental | VM-1500 for 9 volunteers, Placebo for 3 volunteers. Receives: Drug: VM-1500; Drug: Placebo |
| 20 mg VM-1500 or Placebo | Experimental | VM-1500 for 9 volunteers, Placebo for 3 volunteers. Receives: Drug: VM-1500; Drug: Placebo |
| 30 mg VM-1500 or Placebo | Experimental | VM-1500 for 9 volunteers, Placebo for 3 volunteers. Receives: Drug: VM-1500; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of VM-1500 after multiple oral administration in adult healthy subjects based on analysis of AEs and laboratory values.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 14 days during drug administration plus follow-up for four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startJul 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viriom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489435
- Sponsor's protocol ID
- 02/HIV/2010
- Status last verified
- Jun 2015
- First submitted
- 18 Jun 2015
- Last updated
- 3 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02489435
- Acronym / sponsor ID
- 02/HIV/2010
- Conditions
- HIV-infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- ViriomIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 3 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10 mg VM-1500 or Placebo | Experimental | Drug: VM-1500, Drug: PlaceboVM-1500 for 9 volunteers, Placebo for 3 volunteers. |
| 20 mg VM-1500 or Placebo | Experimental | Drug: VM-1500, Drug: PlaceboVM-1500 for 9 volunteers, Placebo for 3 volunteers. |
| 30 mg VM-1500 or Placebo | Experimental | Drug: VM-1500, Drug: PlaceboVM-1500 for 9 volunteers, Placebo for 3 volunteers. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VM-1500VM-1500 | Drug | 10 mg VM-1500 or Placebo, 20 mg VM-1500 or Placebo, 30 mg VM-1500 or Placebo |
| PlaceboPlacebo | Drug | 10 mg VM-1500 or Placebo, 20 mg VM-1500 or Placebo, 30 mg VM-1500 or Placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VM-1500 in people with HIV-infection, run by Viriom at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2015.