Normal Healthy VolunteersPhase 1NCT04188730

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

A Phase 1 study testing Lofexidine (granules for reconstitution) and LUCEMYRA (lofexidine) tablets in people with Normal Healthy Volunteers, run by USWM, LLC (dba US WorldMeds) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Normal Healthy Volunteers
What is being tested?: Lofexidine (granules for reconstitution) and LUCEMYRA (lofexidine) tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 16 Feb 2021to 26 Mar 2021
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Males and females, 18-50 years of age, inclusive, with a Body Mass Index (BMI) of 20.0-35.0 kg/m², inclusive.
Female subjects must meet at least one of the following criterion:
Agree to abstain from sexual intercourse from screening and throughout the duration of the study.
Have used and agree to continue to use a reliable method of contraception (e.g., condom with spermicide, IUD, hormonal contraceptives) for at least 30 days before initial dosing and throughout the duration of the study.
Surgically sterile (bilateral oophorectomy or hysterectomy, bilateral tubal ligation or Essure® device placement at least 3 months prior to initial dosing).
At least 1 year postmenopausal and have a documented FSH level ≥ 40 mIU/mL at screening.
Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
Signed and dated informed consent form, which meets all criteria of current FDA regulations.

Who cannot join

Females who are pregnant, lactating, or likely to become pregnant during the study.
History of allergy or sensitivity to lofexidine or any component of the study drug or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
Significant history or current evidence of chronic infectious disease, system disorders, or organ dysfunction, especially cardiovascular disorders (e.g., severe coronary insufficiency, recent myocardial infarction [within 1 year before initial dosing], cerebrovascular disease), respiratory disorders, congenital long QT syndrome, diabetes, hepatic or renal disorders (e.g., chronic renal failure).
Pulse < 50 bpm or symptomatic bradycardia, as determined by the Investigator.
Clinically significant history of hypotension, as determined by the Investigator, or has a sitting/supine systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 60 mmHg, or hypertension, as determined by the Investigator, or has sitting/supine systolic blood pressure > 190 mmHg and/or diastolic > 95 mmHg; determined at screening.
Experiences reduction of systolic blood pressure of at least 20 mmHg or diastolic blood pressure of at least 10 mmHg within 3 minutes of standing from a resting (sitting or supine) position; determined at screening.

Show all 15Show fewer

12-lead ECG, conducted in triplicate, considered by the Investigator to be clinically significant (e.g., second or third degree heart block, uncontrolled arrhythmia) or has a QTcF (Fridericia's correction) interval > 440 msec in 2 of the 3 ECGs performed; determined at screening.
Clinically significant history or presence of any gastrointestinal disease or history of malabsorption within the last year, as determined by the Investigator.
History of any psychiatric disorders occurring within the last two years that required the subject to be hospitalized or treated with medication.
Subject has history of suicidality based on responses provided on the Columbia-Suicide Severity Rating Scale (C-SSRS), or is at risk for self-harm or harm to others based on clinical interview, at the discretion of the Investigator.
Ingestion of grapefruit-containing food or beverages (e.g., Fresca®) within 7 days before dosing.
Drug or alcohol addiction requiring treatment in the 12 months before initial dosing.
History of excessive alcohol consumption (on average more than 14 units of alcohol/week) during the past 12 months.
Positive test results for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
Positive test results for drugs of abuse (benzodiazepines, cocaine, cannabinoids/THC, opiates and at screening only: amphetamines, barbiturates, methadone and phencyclidine).

Trial locations and contacts

1 site in 1 country.

United States1 site

Novum Pharmaceutical Research Services
Las Vegas, Nevada, 89121

Other trials in United States

About this study

Official title: A Study to Evaluate the Relative Bioavailability of a Test Formulation of Lofexidine Granules for Reconstitution and the Effect of Food on the Bioavailability of the Test Formulation in Healthy Adult Subjects

Conditions: Normal Healthy Volunteers
Being tested: Lofexidine (granules for reconstitution), LUCEMYRA (lofexidine) tablets

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lofexidine (granules for reconstitution)Drug
All subjects will be administered one 0.36 mg dose of lofexidine granules for reconstitution.
LUCEMYRA (lofexidine) tabletsDrug
All subjects will be administered one 0.36 mg dose of LUCEMYRA (lofexidine) tablets.

Study groups in NCT04188730
Study group	Role	What they receive
Lofexidine (granules for reconstitution), fasted	Experimental	Participants will be administered lofexidine granules for reconstitution following an overnight fast of at least 10 hours. Receives: Drug: Lofexidine (granules for reconstitution)
LUCEMYRA (lofexidine) tablets, fasted	Active comparator	Participants will first be administered LUCEMYRA (lofexidine) tablets following an overnight fast of at least 10 hours Receives: Drug: LUCEMYRA (lofexidine) tablets
Lofexidine (granules for reconstitution), fed	Experimental	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. Receives: Drug: Lofexidine (granules for reconstitution)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Feb 202126 Mar 2021

First posted6 Dec 2019
Study start16 Feb 2021
Primary completion26 Mar 2021
Study completion26 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Normal Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04188730
Sponsor's protocol ID: USWM-LX2-1001
Other IDs: R01DA047690
Status last verified: May 2022
First submitted: 25 Nov 2019
Last updated: 15 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Neural and Psychological Mechanisms of Pain Perception
Pain, Normal Physiology
Recruiting
Sociocultural & Biobehavioral Influences on Pain Expression and Assessment
Normal Physiology, Healthy Volunteers
RecruitingObservational study
Studies of Dermatologic Diseases Biospecimen Acquisition Protocol
Dermatologic Conditions, Healthy Volunteers
Recruiting
The Effects of Increasing Caloric Intake on Diet-Induced Thermogenesis and 24h Energy Expenditure
Obesity, Normal Physiology
Not yet recruitingPhase 1
A Research Study to Evaluate BLX-7006 in Healthy Adults
Normal Healthy Volunteer, Safety After Oral Intake

All Normal Healthy Volunteers trials