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Lofexidine Mass Balance in Volunteers

NCT01629446 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2017-10-26

No results posted yet for this 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.

Conditions

  • Normal Healthy Volunteers

Interventions

DRUG

Lofexidine hydrochloride

Single Dose = Solution containing 400 μg lofexidine HCl and a tracer amount of 14C lofexidine

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • USWM, LLC (dba US WorldMeds)

    lead INDUSTRY

Principal Investigators

  • James A Longstreth, PhD · US WorldMeds

  • Charles W Gorodetzky, MD, PhD · US WorldMeds

  • Mark Leibowitz, MD · Worldwide Clinical Trials

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01629446 on ClinicalTrials.gov