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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: VLT-015

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow Region
    • Moscow, Moscow Region, Russian Federation, 115522
      • Federal State Budgetary Scientific Institution "Mental Health Research Centre"
  • Stavropol Oblast
    • Stavropol', Stavropol Oblast, Russian Federation, 355038
      • GBUZ SK Stavropol Regional Clinical Specialized Psychiatric Hospital No. 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients; 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	Drug: VLT-015; 100 mg single dose, 200 mg single dose, 200 mg single dose once a day for two consecutive days; Other Names: FAP-2015

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum plasma concentration	3 weeks
Tmax	Time to reach the maximum concentration	3 weeks
AUC o-t	Area under the pharmacokinetic curve, starting from time zero until the time of last blood sample collection	3 weeks
AUC o - ∞	Area under the pharmacokinetic curve, starting from time zero to infinity	3 weeks
AUC o-t/AUC o-∞	Share of AUC o-t of AUC o-∞ expressed in %	3 weeks
T1/2	Half-life, determined by the formula T_(1/2)= (ln⁡(2))/K_el	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	3 weeks

Collaborators and Investigators

• Sponsor: CF Pharma, LLC
• Investigators: Study Director: Max E Zapolski, Valentech LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: July 22, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 25, 2022

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: tolerability; safety; schizophrenia; pharmacokinetic parameters
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: KI-VLT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No