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

NCT01474278 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2016-11-02

No results posted yet for this study

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

  • Autistic Disorder

Interventions

DRUG

Placebo

Single dose

DRUG

RO5028442

Single dose

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01474278 on ClinicalTrials.gov