A Study of RO5028442 in Adult Male High-Functioning Autistic Patients

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

This multi-center, randomized, double-blind study will evaluate exploratory biomarkers and the safety and tolerability of a single dose of RO5028442 in adult male high-functioning autistic patients. In a cross-over design, patients will be randomized to receive either a single dose of RO5028442 or matching placebo with a washout period of 7-14 days. Anticipated time on study is up to approximately 9 weeks.

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

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• Patients with a diagnosis of Autistic Disorder as defined by DSM-IV, confirmed by the team and supported with the Autistic Diagnostic Observation Schedule (ADOS)

• Male adults, 18 to 45 years of age

• IQ > 70 (Wechsler Adult Intelligence Scale-Full scale)

• Body mass index (BMI) 18 to 35 kg/m2 inclusive

• Aberrant Behavior Checklist (ABC) - Irritability subscale score Exclusion Criteria:

• Positive urine test for drugs of abuse

• Alcohol and/or substance abuse/dependence during the last 12 months

• Positive for hepatitis B, hepatitis C or HIV infection

• Clinically relevant cardiovascular, renal, hepatic or hematologic disease or disorder

• Active inflammatory pulmonary disease

• History of epilepsy/seizure disorder (except for simple febrile seizures)

• Initiation of new or major change in psychosocial intervention within 4 weeks prior to randomization

• Treatment with any investigational agent within 90 days prior to screening

• History of hypersensitivity or allergic reactions