CVN058 Effect on Mismatch Negativity in Schizophrenics
Status: | Recruiting |
---|---|
Conditions: | Schizophrenia |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 12/22/2018 |
Start Date: | November 9, 2018 |
End Date: | June 2019 |
Contact: | David H Margolin, MD, PhD |
Email: | David.Margolin@Cerevance.com |
Phone: | 617-807-7102 |
A Placebo-Controlled Study to Evaluate the Effect of a Single Dose of CVN058 on Mismatch Negativity in Subjects With Stable Schizophrenia
This is a phase 1, double-blind, placebo-controlled, 3 period cross-over study to evaluate
CVN058 target engagement by measuring auditory evoked potential mismatch negativity (MMN)
downstream to 5-hydroxytryptamine receptor 3 (5-HT3) as a pharmacodynamic (PD) marker.
CVN058 target engagement by measuring auditory evoked potential mismatch negativity (MMN)
downstream to 5-hydroxytryptamine receptor 3 (5-HT3) as a pharmacodynamic (PD) marker.
Male and female subjects with schizophrenia, age 18 to 50 years old, inclusive, will be
randomized to 1 of 6 treatment sequences (Table 2.a) to receive 1 of 3 dose regimens in each
period: a single oral administration of CVN058 (15 mg or 150 mg) or matching placebo. The
sequence will determine the order in which a subject will take each of the 3 regimens.
Discontinued subjects may be replaced at the discretion of the sponsor so that approximately
20 completed subjects are available for analysis.
The study includes three 1-day treatment periods, with a minimum of 7-day washout, maximum 10
day washout (2 total washouts, after Periods 1 and 2) between periods, and a 7-10 day
follow-up call post dosing of the last period. Subjects may be inpatients or outpatients at
the discretion of the Investigator.
randomized to 1 of 6 treatment sequences (Table 2.a) to receive 1 of 3 dose regimens in each
period: a single oral administration of CVN058 (15 mg or 150 mg) or matching placebo. The
sequence will determine the order in which a subject will take each of the 3 regimens.
Discontinued subjects may be replaced at the discretion of the sponsor so that approximately
20 completed subjects are available for analysis.
The study includes three 1-day treatment periods, with a minimum of 7-day washout, maximum 10
day washout (2 total washouts, after Periods 1 and 2) between periods, and a 7-10 day
follow-up call post dosing of the last period. Subjects may be inpatients or outpatients at
the discretion of the Investigator.
Inclusion Criteria:
- Subjects 18 to 50 years of age, inclusive, at the time of informed consent.
- The subject weighs at least 50 kg and has a body mass index (BMI) between 18 and 40
kg/m2 inclusive at Screening.
- Subject meets schizophrenia criteria as defined by the Diagnostic & Statistical Manual
of mental Disorders, 5th Edition (DSM-V).
- Subjects are on a stable dose of antipsychotic medication(s) for at least 2 months
prior to - Screening as documented by medical history and assessed by site staff.
- Subject has a Positive and Negative Syndrome Scale (PANSS) total score of <95.
Exclusion Criteria:
- Subject currently receiving treatment with any excluded medication or dietary
supplement.
- Subjects who have a history of gastrointestinal disease that would influence the
absorption of study drug or have a history of any surgical intervention known to
impact absorption (e.g., bariatric surgery or bowel resection).
- Subjects having clinical laboratory evaluations (including clinical chemistry,
hematology and complete urinalysis) outside the reference range for the testing
laboratory, unless the results are deemed to be not clinically significant (NCS) by
the investigator at Screening.
- Subjects with moderate to severe substance use disorder, unstable mood or anxiety
disorder.
- Subject has a current diagnosis of a significant psychiatric illness other than
schizophrenia per DSM-V and is in an acute phase/episode.
- Subject has clinically meaningful hearing loss.
We found this trial at
2
sites
New York State Psychiatric Institute The New York State Psychiatric Institute (NYSPI), established in 1895,...
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