NCT02446002

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: USWM, LLC (dba US WorldMeds) · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

Subjects will be confined to an inpatient facility for a total of 14 nights and 15 days. Subjects who successfully complete screening will report to the inpatient facility (Day -1). At Day 1 all subjects will receive the first single, oral dose of 0.4 mg lofexidine HCl (two 0.2 mg tablets) dosed with 240 mL of water (no food). The lofexidine dose will be followed by a 74-hour interval before beginning naltrexone daily dosing on Day 4 .The first naltrexone administration on Day 4 will be at a dose of approximately 25 mg QD, with subsequent doses on Days 5 to 13 at 50 mg QD. On Day 11, the second single dose of lofexidine (0.4 mg) will be administered and followed by the daily administration of the naltrexone dose (50 mg). The daily administration of naltrexone dose (50 mg) will continue on Day 12 and Day 13.After each administration of lofexidine on Day 1 and Day 11, fingerstick blood samples will be collected for lofexidine pharmacokinetic (PK) analysis before dosing and after dosing at multiple time points.Safety will be assessed by recording adverse events (AEs), measuring vital signs (blood pressure and pulse rate) and clinical laboratory tests (chemistry, hematology, and urinalysis), recording 12-lead safety and Holter electrocardiograms (ECGs), and performing physical exams.

Conditions

• Healthy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2015-05-15
• Last updated: 2017-10-26

Locations

1 site across 1 country: United States