CVN058 Effect on Mismatch Negativity in Schizophrenics

• Status: Completed
• Trial end date: 2020-03-06
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cerevance Alpha, Inc.

Criteria

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.