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

Roche

Status and phase: Completed; Phase 1

Conditions: Autistic Disorder

Treatments: Drug: RO5028442; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01474278

BP27801

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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 </= 13

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

Trial design

19 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: RO5028442

2

Placebo Comparator group

Treatment:

Drug: Placebo