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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.

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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

FieldValue
Enrollment Target 177 participants
Start Date 2011-10
Est. Completion 2012-05
Phase Phase 1

Sponsor

Hoffmann-La Roche

909 total trials

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.