A Study to Investigate the Effects and Safety of Codabakalner for the Treatment of FXS in Male Participants and Adult Participants With ADS

This is a Study to Investigate the Effects and Safety of Codabakalner for the Treatment of Fragile X Syndrome in Male Participants and Adult Participants with Autism Spectrum Disorders

Inclusion Criteria: * Phase 2b: Adult males aged 18 to 45 years, inclusive Phase 3: Males aged 13-45 years, inclusive Mental age \>/= 36mon * Diagnosis of Fragile X as confirmed with genetic testing and Stanford Binet testing or * Confirmed diagnosis ASD per DSM5-TR and EEG criteria * Patient must have caregiver * Must be in good health with no significant medical history Exclusion Criteria: * Any physical or psychological condition that prohibits study completion * Uncontrolled seizures or history of epilepsy with a seizure in the past 6 months. * Auditory or visual impairments that cannot be corrected * History of suicidal behaviour or suicidal ideation * Screening vital signs that are abnormal per protocol specification * ECG that are abnormal and clinically significant * History of substance abuse or dependence within 6 months * Other investigational products within 30 days * Unable to swallow capsules