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NCT01476124 · ClinicalTrials.gov registry record · Phase 1
Drug Drug Interaction Study With Gabapentin Enacarbil and Morphine
A Phase 1 study, sponsored by XenoPort.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01476124: Completed Phase 1 study, sponsored by XenoPort.
NCT01476124 is a Phase 1 study that has completed, run by XenoPort. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01476124, a Phase 1 study, has completed, sponsored by XenoPort.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This double-blind study will evaluate the pharmacokinetics of a single dose of morphine or gabapentin derived from gabapentin enacarbil (GEn) after administration of morphine and GEn alone and in combination as well as the tolerability of morphine administered with GEn. The dose of GEn will be 600 mg administered with food. Morphine/morphine placebo will be administered 2 hours prior to GEn/GEn placebo in the fasted state. A 60 mg dose of a controlled release formulation of morphine will be given. Blood samples for evaluation of gabapentin, morphine and morphine-6-glucuronide will be collected. The pharmacodynamic effect of co-administering both treatments will be assessed using visual analog scales for somnolence/sedation, dizziness and nausea.
Primary Outcome
evaluate the pharmacokinetics of morphine, morphine-6-glucuronide and of gabapentin derived from GEn following administration of single doses of morphine (60 mg) and GEn (600 mg) alone and in combination
Interventions
- DRUG Morphine
- DRUG GEn Placebo
- DRUG morphine Placebo
- DRUG GEn 600 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-08 |
| Est. Completion | 2011-10 |
| Phase | Phase 1 |
What the finished NCT01476124 record still lists
NCT01476124 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 4 interventions - of which Morphine is the first listed.
NCT01476124 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01476124 about?
NCT01476124 is a clinical study titled "Drug Drug Interaction Study With Gabapentin Enacarbil and Morphine". This double-blind study will evaluate the pharmacokinetics of a single dose of morphine or gabapentin derived from gabapentin enacarbil (GEn) after administration of morphine and GEn alone and in combination as well as the tolerability of morphine administered with GEn. The dose of GEn will be 600 m...
What is the current status of trial NCT01476124?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2011-08. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01476124?
The interventions under investigation include: Morphine (DRUG), GEn Placebo (DRUG), morphine Placebo (DRUG), GEn 600 mg (DRUG).
Who is sponsoring clinical trial NCT01476124?
This trial is sponsored by XenoPort, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01476124's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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