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

A Multi-centre, Randomized, Double-blind, Placebo-controlled, Two-period Cross-over, Exploratory Biomarker and Safety and Tolerability Study of a Single Dose of RO5028442 in Adult Male High-functioning Autistic Patients

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01474278

Enrollment

Registered

2011-11-18

Start date

2011-12-31

Completion date

2013-03-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autistic Disorder

Brief 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.

Interventions

DRUGRO5028442

Single dose

DRUGPlacebo

Single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
Efficacy: Behavior assessments	up to 24 hours post-dose
Safety: Incidence of adverse events	up to 24 hours post-dose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026