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VLT-015 in Patients With Schizophrenia (VLT-015)

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
VLT-015
Sponsored by
Valentech LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Schizophrenia focused on measuring pharmacokinetic parameters, tolerability, safety, schizophrenia

Eligibility Criteria

18 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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,

  • 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.

Exclusion Criteria:

  1. 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;
    • 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;
  2. Patients requiring medication or other concomitant therapies listed in the unacceptable concomitant therapy section;
  3. The presence of prostatic hyperplasia or glaucoma in patients;
  4. Diseases of the bone marrow in history;
  5. Active tuberculosis, cystic fibrosis, systemic connective tissue diseases, oncological processes of any localization;
  6. 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);
  7. Alcoholism and drug addiction at the present time, or in history;
  8. Lack of patient willingness to cooperate, non-compliance of the patient;
  9. Participation of the patient in any other clinical study in the last 30 days;
  10. Patients planning to stay in the hospital during the study period for reasons other than the purposes of this clinical trial.

Sites / Locations

  • Federal State Budgetary Scientific Institution "Mental Health Research Centre"Recruiting
  • GBUZ SK Stavropol Regional Clinical Specialized Psychiatric Hospital No. 1

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients

Arm Description

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

Outcomes

Primary Outcome Measures

Cmax
Maximum plasma concentration
Tmax
Time to reach the maximum concentration
AUC o-t
Area under the pharmacokinetic curve, starting from time zero until the time of last blood sample collection
AUC o - ∞
Area under the pharmacokinetic curve, starting from time zero to infinity
AUC o-t/AUC o-∞
Share of AUC o-t of AUC o-∞ expressed in %
T1/2
Half-life, determined by the formula T_(1/2)= (ln⁡(2))/K_el
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

Secondary Outcome Measures

Full Information

First Posted
July 22, 2022
Last Updated
August 29, 2022
Sponsor
Valentech LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05516121
Brief Title
VLT-015 in Patients With Schizophrenia
Acronym
VLT-015
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
October 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valentech LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
pharmacokinetic parameters, tolerability, safety, schizophrenia

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
VLT-015
Other Intervention Name(s)
FAP-2015
Intervention Description
100 mg single dose, 200 mg single dose, 200 mg single dose once a day for two consecutive days
Primary Outcome Measure Information:
Title
Cmax
Description
Maximum plasma concentration
Time Frame
3 weeks
Title
Tmax
Description
Time to reach the maximum concentration
Time Frame
3 weeks
Title
AUC o-t
Description
Area under the pharmacokinetic curve, starting from time zero until the time of last blood sample collection
Time Frame
3 weeks
Title
AUC o - ∞
Description
Area under the pharmacokinetic curve, starting from time zero to infinity
Time Frame
3 weeks
Title
AUC o-t/AUC o-∞
Description
Share of AUC o-t of AUC o-∞ expressed in %
Time Frame
3 weeks
Title
T1/2
Description
Half-life, determined by the formula T_(1/2)= (ln⁡(2))/K_el
Time Frame
3 weeks
Title
MRT
Description
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
Time Frame
3 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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, 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. Exclusion Criteria: 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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Max E Zapolski
Phone
+79160890552
Email
maxzapolski@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Margarita A Morozova, MD, PhD
Phone
+79161277862
Email
margmorozova@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Max E Zapolski
Organizational Affiliation
Valentech LLC
Official's Role
Study Director
Facility Information:
Facility Name
Federal State Budgetary Scientific Institution "Mental Health Research Centre"
City
Moscow
State/Province
Moscow Region
ZIP/Postal Code
115522
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis S Burminsky, MD,PhD
Phone
+79622154282
Email
desbur@gmail.com
Facility Name
GBUZ SK Stavropol Regional Clinical Specialized Psychiatric Hospital No. 1
City
Stavropol'
State/Province
Stavropol Oblast
ZIP/Postal Code
355038
Country
Russian Federation
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
No

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VLT-015 in Patients With Schizophrenia

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