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Assessment of the Effect of Naltrexone on Lofexidine Single Dose Pharmacokinetics in Healthy Subjects

NCT02446002 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-10-26

No results posted yet for this study

Summary

A Phase 1, open-label, single-arm study with two single doses of lofexidine and multiple doses of naltrexone in healthy adult subjects to determine the effect of naltrexone on the single dose pharmacokinetics of the oral lofexidine formulation.

Conditions

  • Healthy

Interventions

DRUG

Lofexidine + Naltrexone

Lofexidine HCl (two 0.2 mg tablets) will be administered as a single oral dose (0.4 mg) on Day 1 and on Day 11.Commercially available naltrexone HCL tablets will be administered as a single oral 25 mg dose on Day 4 and as a single oral 50 mg dose on Days 5 through 13. On Day 11 administration of both naltrexone and lofexidine will occur. Dose administration times for each drug are to be standardized for all treatment days. The scheduling of the naltrexone dose is to be standardized so that the naltrexone dose is administered 2 hours after the lofexidine dose on Day 11 when both drugs are administered.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • USWM, LLC (dba US WorldMeds)

    lead INDUSTRY

Principal Investigators

  • George Atiee, MD · Worldwide Clinical Trials

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-06-30
Completion
2015-06-30

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 NCT02446002 on ClinicalTrials.gov