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NCT01474278 · ClinicalTrials.gov registry record · Phase 1
A Study of RO5028442 in Adult Male High-Functioning Autistic Patients
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT01474278 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 19 participants.
The verdict
NCT01474278, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
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.
Interventions
- DRUG Placebo
- DRUG RO5028442
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01474278
The ClinicalTrials.gov registry entry for NCT01474278 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01474278 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01474278 about?
NCT01474278 is a clinical study titled "A Study of RO5028442 in Adult Male High-Functioning Autistic Patients". 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 m...
What is the current status of trial NCT01474278?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2011-12. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01474278?
The interventions under investigation include: Placebo (DRUG), RO5028442 (DRUG).
Who is sponsoring clinical trial NCT01474278?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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