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NCT01438749 · ClinicalTrials.gov registry record · Phase 1
A Study of The Abuse Liability Potential of RO4917838 in Recreational Drug Users
A Phase 1 study of Healthy Volunteer, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 177
- Enrollment target
- 1
- Study location
NCT01438749 is a Phase 1 study of Healthy Volunteer that has completed, run by Hoffmann-La Roche. The registered enrollment target is 177 participants, below the 200-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (11% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01438749, a Phase 1 study of Healthy Volunteer, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 177 participants
- Enrollment target
- 1
- Study location
Study Summary
This randomized, placebo- and active-controlled, crossover study will evaluate the abuse liability potential of RO4917838 in recreational drug users. In a pre-study (Part 1), subjects will receive a single dose of either diazepam or placebo in an inpatient crossover design, with a wash-out period of at least 10 days between treatments. Subjects who are clearly able to distinguish the positive control from placebo will be enrolled in the main study (Part 2) and will be randomized to single oral doses of RO4917838 (3 dose levels), diazepam and placebo in a double-blind, double-dummy inpatient crossover design. Washout-periods between the 5 treatment periods in Part 2 will be at least 10 days.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG RO4917838
- DRUG diazepam
Study Locations (1)
Utah
- - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 177 participants |
| Start Date | 2011-10 |
| Est. Completion | 2012-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01438749
The ClinicalTrials.gov registry entry for NCT01438749 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 177 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 200-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (11% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01438749 reports 1 study location spanning 1 distinct geographic area - top geographies include Utah.
Frequently Asked Questions
What is clinical trial NCT01438749 about?
NCT01438749 is a clinical study titled "A Study of The Abuse Liability Potential of RO4917838 in Recreational Drug Users". This randomized, placebo- and active-controlled, crossover study will evaluate the abuse liability potential of RO4917838 in recreational drug users. In a pre-study (Part 1), subjects will receive a single dose of either diazepam or placebo in an inpatient crossover design, with a wash-out period of...
What is the current status of trial NCT01438749?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 177 participants. The study started on 2011-10. Estimated completion is 2012-05.
What conditions does trial NCT01438749 study?
This clinical trial studies the following conditions: Healthy Volunteer.
What interventions are being tested in trial NCT01438749?
The interventions under investigation include: Placebo (DRUG), RO4917838 (DRUG), diazepam (DRUG).
Who is sponsoring clinical trial NCT01438749?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01438749 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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