Clinical Trials Directory

Trials / Completed

CompletedNCT01474278

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
Phase
Phase 1
Study type
Interventional
Enrollment
19 (actual)
Sponsor
Hoffmann-La Roche · Industry
Sex
Male
Age
18 Years – 45 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGPlaceboSingle dose
DRUGRO5028442Single dose

Timeline

Start date
2011-12-01
Primary completion
2013-03-01
Completion
2013-03-01
First posted
2011-11-18
Last updated
2016-11-02

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01474278. Inclusion in this directory is not an endorsement.