A Study Evaluating the Relative Bioavailability of Lofexidine Granules for Reconstitution Compared to LUCEMYRA (Lofexidine) Tablets and the Effect of Food on the Bioavailability of the Lofexidine Granules for Reconstitution

Phase 1

Completed

• Conditions: Normal Healthy Volunteers
• Interventions: Drug: Lofexidine (granules for reconstitution); Drug: LUCEMYRA (lofexidine) tablets

• Registration Number: NCT04188730
• Lead Sponsor: USWM, LLC (dba US WorldMeds)

Brief Summary

The purpose of this open-label, single-dose, randomized, three-treatment, three-period, four-sequence, crossover study is to evaluate the relative bioavailability of a test formulation of lofexidine granules for reconstitution (oral) and LUCEMYRA tablets under fasted conditions and to evaluate the effect of food on the relative bioavailability of lofexidine granules for reconstitution (oral) when administered under fed compared to fasted conditions.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-25
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-06
• Study Start: 2021-02-16
• Primary Completion: 2021-03-26
• Study Completion: 2021-03-26
• Results First Submitted: 2022-03-11
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-19
• Last Update Submitted: 2022-05-19
• Results First Posted: 2022-06-15
• Last Update Posted: 2022-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lofexidine (granules for reconstitution), fed	Lofexidine (granules for reconstitution)	Participants will first be administered lofexidine granules for reconstitution, 30 minutes following a standardized breakfast preceded by an overnight fast of at least 10 hours.
Lofexidine (granules for reconstitution), fasted	Lofexidine (granules for reconstitution)	Participants will be administered lofexidine granules for reconstitution following an overnight fast of at least 10 hours.
LUCEMYRA (lofexidine) tablets, fasted	LUCEMYRA (lofexidine) tablets	Participants will first be administered LUCEMYRA (lofexidine) tablets following an overnight fast of at least 10 hours

Primary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-t)	Day 1 through Day 3 for Periods I, II, III.	Areas under the plasma concentration-time curve from time zero to the time of last measurable concentration (AUC0-t)
First-order Terminal Rate Constant (λz)	Mean from Day 1 through Day 3 for Periods I, II, III.
First-order Terminal Half-life (T½)	Mean from Day 1 through Day 3 for Periods I, II, III.
Time to Maximum Plasma Concentration (Tmax)	Day 1 through Day 3 for Periods I, II, III.	Time to peak plasma concentration (h) collection time at which Cmax is first observed.
Mean Maximum Plasma Concentration (Cmax)	Mean from Day 1 through Day 3 for Periods I, II, III.	The peak exposure plasma concentrations (Cmax) of lofexidine were observed and measured.
Area Under the Plasma Concentration-time Curve From Time Zero to Time Infinity (AUC0-∞)	Mean from Day 1 through Day 3 for Periods I, II, III.

Secondary Outcome Measures

Name	Time	Method
Occurrence of Adverse Events (AEs)	Total from occurrences assessed daily after each dosing for Periods 1-3, as well as end of study (22 days)	Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed

Trial Locations

Locations (1)

Novum Pharmaceutical Research Services; 🇺🇸 Las Vegas, Nevada, United States