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NCT01629446 · ClinicalTrials.gov registry record · Phase 1
Lofexidine Mass Balance in Volunteers
A Phase 1 study of Normal Healthy Volunteers, sponsored by USWM, LLC (dba US WorldMeds).
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT01629446: Completed Phase 1 study of Normal Healthy Volunteers, sponsored by USWM, LLC (dba US WorldMeds).
NCT01629446 is a Phase 1 study of Normal Healthy Volunteers that has completed, run by USWM, LLC (dba US WorldMeds). The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01629446, a Phase 1 study of Normal Healthy Volunteers, has completed, sponsored by USWM, LLC (dba US WorldMeds).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to see how lofexidine (investigational study formulation drug) is absorbed, broken down, and removed from the body. To do this, a special form of the study drug will be used that has a radioactive carbon atom attached. Blood, urine, and feces samples will be collected at different times to measure the amount of the study drug and radioactivity they contain. The amount of radioactivity you will be exposed to is less than the amount of radiation from a regular X-ray.
Primary Outcome
To study the absorption, distribution, metabolism, and elimination (ADME), trace amounts of 14C compounds are quantified using accelerator mass spectrometry (AMS). As a form of an isotope ratio atom counter that achieves the lowest detection limits of any type of mass spectrometry, AMS provides quantitative sensitivity towards 14C labeled compounds to low attomole (10-18) levels. This high degree of sensitivity enables the detection of compounds in very small specimens and/or tissues after admin
Conditions Studied
Interventions
- DRUG Lofexidine hydrochloride
Study Locations (1)
Texas
- Worldwide Clinical Trials - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2012-05 |
| Est. Completion | 2012-06 |
| Phase | Phase 1 |
What the finished NCT01629446 record still lists
NCT01629446 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Normal Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which Lofexidine hydrochloride is the first listed.
NCT01629446 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01629446 about?
NCT01629446 is a clinical study titled "Lofexidine Mass Balance in Volunteers". The purpose of this study is to see how lofexidine (investigational study formulation drug) is absorbed, broken down, and removed from the body. To do this, a special form of the study drug will be used that has a radioactive carbon atom attached. Blood, urine, and feces samples will be collected at...
What is the current status of trial NCT01629446?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2012-05. Estimated completion is 2012-06.
What conditions does trial NCT01629446 study?
This clinical trial studies the following conditions: Normal Healthy Volunteers.
What interventions are being tested in trial NCT01629446?
The interventions under investigation include: Lofexidine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01629446?
This trial is sponsored by USWM, LLC (dba US WorldMeds), which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01629446 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Normal Healthy Volunteers
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01629446's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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