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NCT02318836 · ClinicalTrials.gov registry record · Phase 1
Single-Dose Pharmacokinetics and Safety of Oral Lofexidine in Hepatically-Impaired Subjects
A Phase 1 study, sponsored by USWM, LLC (dba US WorldMeds).
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02318836: Completed Phase 1 study, sponsored by USWM, LLC (dba US WorldMeds).
NCT02318836 is a Phase 1 study that has completed, run by USWM, LLC (dba US WorldMeds). The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02318836, a Phase 1 study, has completed, sponsored by USWM, LLC (dba US WorldMeds).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a Phase 1, open-label, parallel-group, single-dose study of lofexidine in 6 adult subjects with mild hepatic impairment (Child Pugh score of 5 6), 6 adult subjects with moderate hepatic impairment (Child Pugh score 7 9), 6 adult subjects with severe hepatic impairment (Child Pugh score 10 15), and 6 control subjects with normal hepatic function with mean age, body mass index (BMI), and gender distribution targeted to be similar to the impaired hepatic function cohorts.
Primary Outcome
Cmax, Tmax, AUC, λz, CL/F, T½, CLr, CLd, Ae
Interventions
- DRUG Lofexidine Hydrochloride (HCl) tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2014-06 |
| Est. Completion | 2014-10 |
| Phase | Phase 1 |
What the finished NCT02318836 record still lists
NCT02318836 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which Lofexidine Hydrochloride (HCl) tablets is the first listed.
NCT02318836 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02318836 about?
NCT02318836 is a clinical study titled "Single-Dose Pharmacokinetics and Safety of Oral Lofexidine in Hepatically-Impaired Subjects". This is a Phase 1, open-label, parallel-group, single-dose study of lofexidine in 6 adult subjects with mild hepatic impairment (Child Pugh score of 5 6), 6 adult subjects with moderate hepatic impairment (Child Pugh score 7 9), 6 adult subjects with severe hepatic impairment (Child Pugh score 10 15...
What is the current status of trial NCT02318836?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2014-06. Estimated completion is 2014-10.
What interventions are being tested in trial NCT02318836?
The interventions under investigation include: Lofexidine Hydrochloride (HCl) tablets (DRUG).
Who is sponsoring clinical trial NCT02318836?
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 NCT02318836's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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