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NCT01483469 · ClinicalTrials.gov registry record · Phase 1
A Human Proof of Concept Study for [11C]-RO5011232 as Radiotracer and Study of the Binding of RO4917523 to Human mGlu5 Brain Receptor at Steady-State in Healthy Volunteers
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT01483469 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 56 participants.
The verdict
NCT01483469, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
This open label, non-randomized, parallel group study will evaluate \[11C\]-RO5011232 as radiotracer for brain mGlu5 receptor occupancy and investigate the binding of RO49917523 to human mGlu5 brain receptor at steady-state in healthy volunteers. In Parts I, II and III, positron emission tomography (PET) assessments of specific uptake of the radiotracer and whole body dosimetry will be made after intravenous injection of \[11C\]-RO5011232. In Part IV, subjects will receive RO4917523 orally daily for 14 days while receiving three single intravenous bolus injections of \[11C\]-RO5011232. The anticipated time on study treatment is up to 4 weeks.
Interventions
- DRUG RO4917523
- DRUG RO5011232
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01483469
The ClinicalTrials.gov registry entry for NCT01483469 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 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 RO4917523 is the first listed.
NCT01483469 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01483469 about?
NCT01483469 is a clinical study titled "A Human Proof of Concept Study for [11C]-RO5011232 as Radiotracer and Study of the Binding of RO4917523 to Human mGlu5 Brain Receptor at Steady-State in Healthy Volunteers". This open label, non-randomized, parallel group study will evaluate \[11C\]-RO5011232 as radiotracer for brain mGlu5 receptor occupancy and investigate the binding of RO49917523 to human mGlu5 brain receptor at steady-state in healthy volunteers. In Parts I, II and III, positron emission tomography ...
What is the current status of trial NCT01483469?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2011-12. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01483469?
The interventions under investigation include: RO4917523 (DRUG), RO5011232 (DRUG).
Who is sponsoring clinical trial NCT01483469?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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