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NCT01235338 · ClinicalTrials.gov registry record · Phase 1
Co-Administration of LDX (SPD489) and Venlafaxine XR (EFFEXOR XR) in Healthy Volunteers
A Phase 1 study, sponsored by Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT01235338: Completed Phase 1 study, sponsored by Shire.
NCT01235338 is a Phase 1 study that has completed, run by Shire. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01235338, a Phase 1 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
This study will examine the effects of co-administration of SPD489 and the antidepressant EFFEXOR XR on the pharmacokinetics of lisdexamfetamine, d-amphetamine, and EFFEXOR XR. In addition, serial blood pressure and pulse measures will be obtained and examined to ensure that there are no unexpected changes in vital signs following co administration of SPD489 and EFFEXOR XR that would impact the further study of this drug combination. The hypothesis is that a drug drug interaction could possibly exist.
Primary Outcome
Lisdexamfetamine dimesylate (SPD489) itself is inactive, but following oral administration is converted to the active isomer, d-amphetamine, that is responsible for the drug's therapeutic activity.
Interventions
- DRUG LDX + Venlafaxine XR
- DRUG Venlafaxine XR + LDX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2010-10-28 |
| Est. Completion | 2011-01-17 |
| Phase | Phase 1 |
What the finished NCT01235338 record still lists
NCT01235338 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).
The record links to 0 conditions, and to 2 interventions - of which LDX + Venlafaxine XR is the first listed.
NCT01235338 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01235338 about?
NCT01235338 is a clinical study titled "Co-Administration of LDX (SPD489) and Venlafaxine XR (EFFEXOR XR) in Healthy Volunteers". This study will examine the effects of co-administration of SPD489 and the antidepressant EFFEXOR XR on the pharmacokinetics of lisdexamfetamine, d-amphetamine, and EFFEXOR XR. In addition, serial blood pressure and pulse measures will be obtained and examined to ensure that there are no unexpected ...
What is the current status of trial NCT01235338?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2010-10-28. Estimated completion is 2011-01-17.
What interventions are being tested in trial NCT01235338?
The interventions under investigation include: LDX + Venlafaxine XR (DRUG), Venlafaxine XR + LDX (DRUG).
Who is sponsoring clinical trial NCT01235338?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01235338's enrollment target sits among peer trials
80 672nd of 2000 higher than 1,305 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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