CompletedPhase 1

VLT-015 in Patients With Schizophrenia

Russia15 participantsStarted 2021-02-01

Plain-language 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.

Who can participate

Age range

18 Years – 50 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. 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;
. 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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cmax

Timeframe: 3 weeks

Tmax

Timeframe: 3 weeks

AUC o-t

Timeframe: 3 weeks

AUC o - ∞

Timeframe: 3 weeks

AUC o-t/AUC o-∞

Timeframe: 3 weeks

T1/2

Timeframe: 3 weeks

MRT

Timeframe: 3 weeks

Trial details

NCT IDNCT05516121

SponsorCF Pharma, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-30

View on ClinicalTrials.gov More Schizophrenia trials

Who can participate

Age range

18 Years – 50 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. 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;
. 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;