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

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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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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.

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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

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04188730
Acronym / sponsor ID: USWM-LX2-1001
Conditions: Normal Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: USWM, LLC (dba US WorldMeds)Industry (pharma, biotech, devices)
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 16 Feb 2021 (actual)
Primary completion: 26 Mar 2021 (actual)
Study completion: 26 Mar 2021 (actual)
First posted: 6 Dec 2019 (actual)
Results: Posted 15 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Lofexidine (granules for reconstitution), fasted	Experimental	Drug: 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	Active comparator	Drug: LUCEMYRA (lofexidine) tabletsParticipants will first be administered LUCEMYRA (lofexidine) tablets following an overnight fast of at least 10 hours
Lofexidine (granules for reconstitution), fed	Experimental	Drug: 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.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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:
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.

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lofexidine (granules for reconstitution)All subjects will be administered one 0.36 mg dose of lofexidine granules for reconstitution.	Drug	Lofexidine (granules for reconstitution), fasted, Lofexidine (granules for reconstitution), fed
LUCEMYRA (lofexidine) tabletsAll subjects will be administered one 0.36 mg dose of LUCEMYRA (lofexidine) tablets.	Drug	LUCEMYRA (lofexidine) tablets, fasted

Primary outcome

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

1 secondary outcome

Occurrence of Adverse Events (AEs)
Time frame: Total from occurrences assessed daily after each dosing for Periods 1-3, as well as end of study (22 days)

Results and safety

Results posted to the registry on 15 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1: Treatment B, Treatment A, Treatment C	4	3
Sequence 2: Treatment B, Treatment C, Treatment A	4	4
Sequence 3: Treatment A, Treatment C, Treatment B	4	4
Sequence 4: Treatment C, Treatment A, Treatment B	4	4

Primary outcome: Mean Maximum Plasma Concentration (Cmax)

Time frame: Mean from Day 1 through Day 3 for Periods I, II, III.. Mean (Standard Deviation). Unit: ng/mL

Measure	Treatment A: Lofexidine Granules - Fasted Conditions n = 15	Treatment B: LUCEMYRA Tablets - Fasted Conditions n = 15	Treatment C: Lofexidine Granules - Fed Conditions n = 15
Value	0.6984 (0.1661)	0.7275 (0.1657)	0.6977 (0.1656)

Population analysed: Only sufficient data for 15 of the 16 participants to be analyzed for Pharmacokinetic data due to one participant dropping out after Sequence 1 of the study.

Primary outcome: Time to Maximum Plasma Concentration (Tmax)

Time frame: Day 1 through Day 3 for Periods I, II, III.. Mean (Standard Deviation). Unit: hours

Measure	Treatment A: Lofexidine Granules - Fasted Conditions n = 15	Treatment B: LUCEMYRA Tablets - Fasted Conditions n = 15	Treatment C: Lofexidine Granules - Fed Conditions n = 15
Value	4.2678 (1.3894)	4.3367 (1.2364)	4.5344 (1.6435)

Population analysed: Only sufficient data for 15 of the 16 participants to be analyzed for Pharmacokinetic data due to one participant dropping out after Sequence 1 of the study.

Primary outcome: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-t)

Time frame: Day 1 through Day 3 for Periods I, II, III.. Mean (Standard Deviation). Unit: h*ng/mL

Measure	Treatment A: Lofexidine Granules - Fasted Conditions n = 15	Treatment B: LUCEMYRA Tablets - Fasted Conditions n = 15	Treatment C: Lofexidine Granules - Fed Conditions n = 15
Value	12.1333 (4.965)	12.2450 (4.142)	12.4540 (4.517)

Population analysed: Only sufficient data for 15 of the 16 participants to be analyzed for Pharmacokinetic data due to one participant dropping out after Sequence 1 of the study.

Primary outcome: Area Under the Plasma Concentration-time Curve From Time Zero to Time Infinity (AUC0-∞)

Time frame: Mean from Day 1 through Day 3 for Periods I, II, III.. Mean (Standard Deviation). Unit: h·ng/mL

Measure	Treatment A: Lofexidine Granules - Fasted Conditions n = 15	Treatment B: LUCEMYRA Tablets - Fasted Conditions n = 15	Treatment C: Lofexidine Granules - Fed Conditions n = 15
Value	14.9643 (6.063)	14.7229 (4.411)	14.9004 (5.021)

Population analysed: Only sufficient data for 15 of the 16 participants to be analyzed for Pharmacokinetic data due to one participant dropping out after Sequence 1 of the study.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Daily after each dosing for Periods 1-3, as well as End of Study Day 3 Period 3 (22 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A: Lofexidine Granules - Fasted Conditions	0 of 15 (0%)	3 of 15 (20%)	0 of 15
Treatment B: LUCEMYRA Tablets - Fasted Conditions	0 of 16 (0%)	8 of 16 (50%)	0 of 16
Treatment C: Lofexidine Granules - Fed Conditions	0 of 15 (0%)	7 of 15 (46.7%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kim New study director

USWM, LLC (dba US WorldMeds)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Maximum Plasma Concentration (Cmax) (time frame: Mean from Day 1 through Day 3 for Periods I, II, III.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04188730.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.