A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder

Inclusion Criteria:

- Diagnosis of Autism Spectrum Disorder (ASD) according to Diagnostic and Statistical
Manual of Mental Disorders - 5th Edition (DSM-5) criteria and made or confirmed using
the Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2) (minimum score of 8
[autism spectrum])

- Otherwise healthy for their age group or medically stable with or without medication
on the basis of physical examination, medical history, vital signs, 12-lead
electrocardiogram (ECG), and clinical laboratory tests

- Have a composite score on Kaufman Brief Intelligence Test, Second Edition (KBIT-2) of
at least 60

- Must live with a parent or primary caregiver or, if not, during each week he/she must
either (A) spend at least 3 hours a day for at least 4 days or, (B) spend the weekend
with a parent or primary caregiver

- Any pharmacologic, diet, or behavioral intervention for ASD must have begun at least 1
month prior to the baseline visit and continue unchanged through the treatment period,
or have ended at least 1 month prior to the baseline visit

- Must be able to swallow the study medication whole and self-administer medication if
living independently or have a parent or caregiver be able to administer medication

- Must agree to abide by the birth control requirements during the study and for 3
months after the last dose

Exclusion Criteria:

- Current or recent history of clinically significant suicidal ideation within the past
6 months, or a history of suicidal behavior within the past year

- Use of a drug with moderate/strong cytochrome P450 (CYP)3A4 inhibiting or inducing
properties at, or prior to, screening that is not discontinued at least within 1 month
prior to Day 1

- History of drug or alcohol use disorder according to DSM-5 criteria within 6 months
before screening or positive test result(s) for alcohol or drugs of abuse (except if
related to current treatment)

- Currently taking or has taken within the past month recreational or medically
prescribed cannabis