SchizophreniaPhase 1VLT-015NCT05516121
VLT-015 in Patients With Schizophrenia
A Phase 1 study testing VLT-015 in people with Schizophrenia, run by CF Pharma, LLC at 2 sites in Russia.
Trial summary
15 stable patients diagnosed with schizophrenia take 100 mg of VLT-015 once a day, 200 mg of VLT-015 once a day and 200 mg of VLT-015 on two consecutive days with an interval of 24 hours between doses. PK parameters are measured, tolerability and safety of the product are evaluated. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Schizophrenia
- What is being tested?
- VLT-015
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesRussia
- Study dates
- 1 Feb 2021to 30 Oct 2022
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Male patients aged 18 to 50
- Availability of a voluntarily signed Information Consent (Patient Information Sheet) for participation in this clinical research and further hospitalization;
- The diagnosis of schizophrenia established in the anamnesis
- The patient's stay in remission** based on the decision of the investigator before and after the withdrawal of maintenance therapy.
- Criteria determining the state of remission:
- the sum of points of the Positive and Negative Symptom Scale (PANSS) according to positive Marder factor is less than 22 points,
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- each item score of the positive Marder factor (delusions, hallucinatory behavior, grandiosity, suspicion, stereotyped thinking, somatic anxiety, unusual thought content, decreased criticism) less than 4 points
- Absence of taking antipsychotic drugs for 5 periods half-life of the drug taken;
- The patient's ability to adequately cooperate (the ability to understand provided information about the clinical trial, readiness for compliance with the requirements of the study protocol);
- Agree to use barrier methods of contraception during the study and within 2 months after completion of the study.
Who cannot join
- The presence of contraindications to the use of VLT-015:
- dysfunction of the bone marrow;
- hypersensitivity to VLT-015 and other components of the drug;
- toxic or idiosyncratic granulocytopenia/agranulocytosis in history;
- epilepsy;
- alcohol, drug intoxication and coma;
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- collapse, depression of the central nervous system of any etiology;
- severe kidney or heart disease;
- paralytic intestinal obstruction;
- glucose-galactose malabsorption;
- renal or hepatic insufficiency;
- Patients requiring medication or other concomitant therapies listed in the unacceptable concomitant therapy section;
- The presence of prostatic hyperplasia or glaucoma in patients;
- Diseases of the bone marrow in history;
- Active tuberculosis, cystic fibrosis, systemic connective tissue diseases, oncological processes of any localization;
- Severe, decompensated or unstable somatic diseases (any diseases or conditions that threaten the patient's life or worsen the prognosis patient, and also make it impossible to conduct a clinical trial);
- Alcoholism and drug addiction at the present time, or in history;
- Lack of patient willingness to cooperate, non-compliance of the patient;
- Participation of the patient in any other clinical study in the last 30 days;
- Patients planning to stay in the hospital during the study period for reasons other than the purposes of this clinical trial.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Federal State Budgetary Scientific Institution "Mental Health Research Centre"
Moscow, Moscow Oblast, 115522
GBUZ SK Stavropol Regional Clinical Specialized Psychiatric Hospital No. 1
Stavropol, Stavropol Oblast, 355038
About this study
Official title: An Open Non-comparative Clinical Trial of the Pharmacokinetics, Safety and Tolerability of VLT-015, Tablets, 100 mg (Valentech LLC) With Single and Multiple Use in Patients With Schizophrenia
15 stable patients diagnosed with schizophrenia take 100 mg of VLT-015 once a day, 200 mg of VLT-015 once a day and 200 mg of VLT-015 on two consecutive days with an interval of 24 hours between doses. PK parameters are measured, tolerability and safety of the product are evaluated.
Read the detailed description
At stage 1, 15 stable patients diagnosed with schizophrenia take 1 tablet of VLT-015 (100 mg) followed by blood sampling to measure the level of the active substance and its main metabolite within 72 hours. After that patients have 3 days washout period.
At the second stage, the same 15 patients take two 100 mg tablets of VLT-015 (200 mg) followed by blood sampling to measure the level of the active substance and its main metabolite within 72 hours. Then patients have the same 3 days washout period.
At stage 3, the same patients take 2 tablets of VLT-015 (200 mg) consecutively for 2 days with 24-hours interval followed by blood sampling to measure the level of the active substance and its main metabolite within 96 hours.
PK parameters are measured, tolerability and safety of the product are evaluated.
- Conditions
- Schizophrenia
- Being tested
- VLT-015
- Keywords
- pharmacokinetic parameters, tolerability, safety, schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VLT-015Drug
Also called FAP-2015
100 mg single dose, 200 mg single dose, 200 mg single dose once a day for two consecutive days
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | Each patient takes 100 mg single dose, after wash-out period 200 mg single dose, then, after wash-out period 200 mg single dose two following days Receives: Drug: VLT-015 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum plasma concentration
Measured: 3 weeks
Tmax
Time to reach the maximum concentration
Measured: 3 weeks
AUC o-t
Area under the pharmacokinetic curve, starting from time zero until the time of last blood sample collection
Measured: 3 weeks
AUC o - ∞
Area under the pharmacokinetic curve, starting from time zero to infinity
Measured: 3 weeks
AUC o-t/AUC o-∞
Share of AUC o-t of AUC o-∞ expressed in %
Measured: 3 weeks
T1/2
Half-life, determined by the formula T_(1/2)= (ln(2))/K_el
Measured: 3 weeks
MRT
Mean retention time of the drug in the body, calculated from the start of the first time point to the time the last blood sample was taken
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start1 Feb 2021
- Primary completion30 Sep 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- CF Pharma, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Max E Zapolski, Study director, Valentech LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516121
- Sponsor's protocol ID
- KI-VLT-001
- Acronym
- VLT-015
- Status last verified
- Aug 2024
- First submitted
- 22 Jul 2022
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Non-comparative Clinical Trial of the Pharmacokinetics, Safety and Tolerability of VLT-015, Tablets, 100 mg (Valentech LLC) With Single and Multiple Use in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT05516121
- Acronym / sponsor ID
- VLT-015 / KI-VLT-001
- Conditions
- Schizophrenia
- Keywords
- pharmacokinetic parameters, tolerability, safety, schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- CF Pharma, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 25 Aug 2022 (actual)
- 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.
15 stable patients diagnosed with schizophrenia take 100 mg of VLT-015 once a day, 200 mg of VLT-015 once a day and 200 mg of VLT-015 on two consecutive days with an interval of 24 hours between doses. PK parameters are measured, tolerability and safety of the product are evaluated.
Detailed description
At stage 1, 15 stable patients diagnosed with schizophrenia take 1 tablet of VLT-015 (100 mg) followed by blood sampling to measure the level of the active substance and its main metabolite within 72 hours. After that patients have 3 days washout period.
At the second stage, the same 15 patients take two 100 mg tablets of VLT-015 (200 mg) followed by blood sampling to measure the level of the active substance and its main metabolite within 72 hours. Then patients have the same 3 days washout period.
At stage 3, the same patients take 2 tablets of VLT-015 (200 mg) consecutively for 2 days with 24-hours interval followed by blood sampling to measure the level of the active substance and its main metabolite within 96 hours.
PK parameters are measured, tolerability and safety of the product are evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Drug: VLT-015Each patient takes 100 mg single dose, after wash-out period 200 mg single dose, then, after wash-out period 200 mg single dose two following days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male patients aged 18 to 50
- Availability of a voluntarily signed Information Consent (Patient Information Sheet) for participation in this clinical research and further hospitalization;
- The diagnosis of schizophrenia established in the anamnesis
- The patient's stay in remission** based on the decision of the investigator before and after the withdrawal of maintenance therapy.
- the sum of points of the Positive and Negative Symptom Scale (PANSS) according to positive Marder factor is less than 22 points,
Key exclusion criteria (20 listed)
- The presence of contraindications to the use of VLT-015:
- Patients requiring medication or other concomitant therapies listed in the unacceptable concomitant therapy section;
- The presence of prostatic hyperplasia or glaucoma in patients;
- Diseases of the bone marrow in history;
- Active tuberculosis, cystic fibrosis, systemic connective tissue diseases, oncological processes of any localization;
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 |
|---|---|---|
| VLT-015Also: FAP-2015100 mg single dose, 200 mg single dose, 200 mg single dose once a day for two consecutive days | Drug | patients |
Primary outcome
Cmax
Time frame: 3 weeks
Maximum plasma concentration
Tmax
Time frame: 3 weeks
Time to reach the maximum concentration
AUC o-t
Time frame: 3 weeks
Area under the pharmacokinetic curve, starting from time zero until the time of last blood sample collection
AUC o - ∞
Time frame: 3 weeks
Area under the pharmacokinetic curve, starting from time zero to infinity
AUC o-t/AUC o-∞
Time frame: 3 weeks
Share of AUC o-t of AUC o-∞ expressed in %
T1/2
Time frame: 3 weeks
Half-life, determined by the formula T_(1/2)= (ln(2))/K_el
MRT
Time frame: 3 weeks
Mean retention time of the drug in the body, calculated from the start of the first time point to the time the last blood sample was taken
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 21 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Max E Zapolski study director
Valentech LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VLT-015 in people with Schizophrenia, run by CF Pharma, LLC at 2 sites 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 10 inclusion and 20 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 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Cmax (time frame: 3 weeks). The study lists 7 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 21 Aug 2024.