VLT-015 in Patients With Schizophrenia

NCT05516121 | Completed Phase 1

• 1 other identifier: KI-VLT-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Schizophrenia

Keywords

pharmacokinetic parameters; tolerability; safety; schizophrenia

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (1)

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

Drug: VLT-015

Interventions

VLT-015 DRUG

100 mg single dose, 200 mg single dose, 200 mg single dose once a day for two consecutive days

Also known as: FAP-2015

patients

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• CF Pharma, LLC: lead

Study Sites (2)

Federal State Budgetary Scientific Institution "Mental Health Research Centre"

Moscow, Moscow Oblast, 115522, Russia

Location

GBUZ SK Stavropol Regional Clinical Specialized Psychiatric Hospital No. 1

Stavropol, Stavropol Oblast, 355038, Russia

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Max E Zapolski

  Valentech LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: August 25, 2022
• Study Start: February 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: October 30, 2022
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)