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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 is a Phase 1 study that has completed, run by USWM, LLC (dba US WorldMeds). The registered enrollment target is 24 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02318836
The ClinicalTrials.gov registry entry for NCT02318836 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is USWM, LLC (dba US WorldMeds), which has 16 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lofexidine Hydrochloride (HCl) tablets is the first listed.
NCT02318836 reports 0 study locations.
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.
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