A Single-Center, Open-Label, Single-Period, Single-Treatment Study to Determine the Mass Balance of a Single Oral Dose of 14C Labeled Lofexidine

NCT01629446 Phase 1 COMPLETED

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.

Details

Lead sponsor	USWM, LLC (dba US WorldMeds)
Phase	Phase 1
Status	COMPLETED
Enrolment	6
Start date	2012-05
Completion	2012-06

Conditions

• Normal Healthy Volunteers

Interventions

• Lofexidine hydrochloride

Primary outcomes

• Mass Balance — plasma, urine, and fecal samples up to 216 hours post dose
  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 administration of doses that can be both chemically and radiochemically small (microdose levels).

Countries

United States