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NCT02446002 · ClinicalTrials.gov registry record · Phase 1
Assessment of the Effect of Naltrexone on Lofexidine Single Dose Pharmacokinetics in Healthy Subjects
A Phase 1 study, sponsored by USWM, LLC (dba US WorldMeds).
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT02446002: Completed Phase 1 study, sponsored by USWM, LLC (dba US WorldMeds).
NCT02446002 is a Phase 1 study that has completed, run by USWM, LLC (dba US WorldMeds). The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02446002, a Phase 1 study, has completed, sponsored by USWM, LLC (dba US WorldMeds).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
A Phase 1, open-label, single-arm study with two single doses of lofexidine and multiple doses of naltrexone in healthy adult subjects to determine the effect of naltrexone on the single dose pharmacokinetics of the oral lofexidine formulation.
Primary Outcome
Descriptive statistics will be used to summarize lofexidine concentrations at each time point and PK parameters by treatment phase.Comparisons will be made between Day 1 and Day 11 for Cmax, AUC0-24, AUC0-t, AUC0-∞, Tmax, and t1/2
Interventions
- DRUG Lofexidine + Naltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2015-05 |
| Est. Completion | 2015-06 |
| Phase | Phase 1 |
What the finished NCT02446002 record still lists
NCT02446002 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 1 intervention - of which Lofexidine + Naltrexone is the first listed.
NCT02446002 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02446002 about?
NCT02446002 is a clinical study titled "Assessment of the Effect of Naltrexone on Lofexidine Single Dose Pharmacokinetics in Healthy Subjects". A Phase 1, open-label, single-arm study with two single doses of lofexidine and multiple doses of naltrexone in healthy adult subjects to determine the effect of naltrexone on the single dose pharmacokinetics of the oral lofexidine formulation.
What is the current status of trial NCT02446002?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2015-05. Estimated completion is 2015-06.
What interventions are being tested in trial NCT02446002?
The interventions under investigation include: Lofexidine + Naltrexone (DRUG).
Who is sponsoring clinical trial NCT02446002?
This trial is sponsored by USWM, LLC (dba US WorldMeds), which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02446002's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 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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