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A Relative Bioavailability Study Comparing Lofexidine Granules for Reconstitution to LUCEMYRA® (Lofexidine) Tablets

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04188730
Recruitment Status : Suspended (Study on Hold)
First Posted : December 6, 2019
Last Update Posted : October 14, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
US WorldMeds LLC

Brief Summary:
The purpose of this Phase 1, open-label, single-dose, randomized, two-treatment, two-period, two-sequence, crossover study is to assess the bioavailability of lofexidine granules for reconstitution to that of an equal dose of LUCEMYRA (lofexidine) tablets under fasted conditions in healthy, non-tobacco-, non-nicotine-using adult male and female participants.

Condition or disease Intervention/treatment Phase
Normal Healthy Volunteers Drug: Lofexidine (granules for reconstitution) Drug: LUCEMYRA (lofexidine) tablets Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Study to Evaluate the Relative Bioavailability of a Test Formulation of Lofexidine Granules for Reconstitution (Oral) Compared to an Equal Dose of LUCEMYRA® (Lofexidine) Tablets in Healthy Adult Subjects Under Fasted Conditions
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Active Comparator: Granules for reconstitution then tablets
Participants will first be administered one 0.36 mg dose of lofexidine granules for reconstitution. After a washout period of 7 days, participants will be administered one 0.36 mg dose of LUCEMYRA (lofexidine) tablets.
Drug: Lofexidine (granules for reconstitution)
All subjects will be administered one 0.36 mg dose of lofexidine granules for reconstitution.

Drug: LUCEMYRA (lofexidine) tablets
All subjects will be administered one 0.36 mg dose of LUCEMYRA (lofexidine) tablets.

Active Comparator: Tablets then granules for reconstitution
Participants will first be administered one 0.36 mg dose of LUCEMYRA (lofexidine) tablets. After a washout period of 7 days, participants will be administered one 0.36 mg dose of lofexidine granules for reconstitution.
Drug: Lofexidine (granules for reconstitution)
All subjects will be administered one 0.36 mg dose of lofexidine granules for reconstitution.

Drug: LUCEMYRA (lofexidine) tablets
All subjects will be administered one 0.36 mg dose of LUCEMYRA (lofexidine) tablets.




Primary Outcome Measures :
  1. Maximum Plasm Concentration (Cmax) [ Time Frame: Time Frame: pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 7.0, 10.0, 16.0, 24.0, 30.0, 36.0, 48.0 and 54.0 hours post-dose in Periods I and II ]
  2. Time to maximum Plasma Concentration (Tmax) [ Time Frame: Time Frame: pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 7.0, 10.0, 16.0, 24.0, 30.0, 36.0, 48.0 and 54.0 hours post-dose in Periods I and II ]
  3. Area under the plasma concentration-time curve from time zero to the time of last measurable concentration (AUC0-t) [ Time Frame: Time Frame: pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 7.0, 10.0, 16.0, 24.0, 30.0, 36.0, 48.0 and 54.0 hours post-dose in Periods I and II ]
  4. Area under the plasma concentration-time curve from time zero to time infinity (AUC0-∞) [ Time Frame: Time Frame: pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 7.0, 10.0, 16.0, 24.0, 30.0, 36.0, 48.0 and 54.0 hours post-dose in Periods I and II ]
  5. First-order terminal rate constant (λz) [ Time Frame: Time Frame: pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 7.0, 10.0, 16.0, 24.0, 30.0, 36.0, 48.0 and 54.0 hours post-dose in Periods I and II ]
  6. First-order terminal half-life (T½) [ Time Frame: Time Frame: pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 7.0, 10.0, 16.0, 24.0, 30.0, 36.0, 48.0 and 54.0 hours post-dose in Periods I and II ]

Secondary Outcome Measures :
  1. Occurrence of Adverse Events (AEs) [ Time Frame: Dosing on Day 1 through study completion (an average of 10 days) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  1. Males and females, 18-50 years of age, inclusive, with a Body Mass Index (BMI) of 20.0-35.0 kg/m², inclusive.
  2. 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.
  3. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
  4. Signed and dated informed consent form, which meets all criteria of current FDA regulations.

Exclusion Criteria

  1. Females who are pregnant, lactating, or likely to become pregnant during the study.
  2. 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.
  3. 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), congenital long QT syndrome, hepatic or renal disorders (e.g., chronic renal failure).
  4. Pulse < 50 bpm or symptomatic bradycardia, as determined by the Investigator.
  5. 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.
  6. 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.
  7. 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.
  8. Clinically significant history or presence of any gastrointestinal disease or history of malabsorption within the last year, as determined by the Investigator.
  9. History of any psychiatric disorders occurring within the last two years that required the subject to be hospitalized or treated with medication.
  10. 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.
  11. Drug or alcohol addiction requiring treatment in the 12 months before initial dosing.
  12. History of excessive alcohol consumption (on average more than 14 units of alcohol/week) during the past 12 months.
  13. Positive test results for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
  14. Positive test results for drugs of abuse (benzodiazepines, cocaine, cannabinoids/THC, opiates and at screening only: amphetamines, barbiturates, methadone and phencyclidine).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04188730


Locations
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United States, Nevada
Novum Pharmaceutical Research Services
Las Vegas, Nevada, United States, 89121
Sponsors and Collaborators
US WorldMeds LLC
National Institute on Drug Abuse (NIDA)
Investigators
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Study Director: Kim New US WorldMeds LLC
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Responsible Party: US WorldMeds LLC
ClinicalTrials.gov Identifier: NCT04188730    
Other Study ID Numbers: USWM-LX2-1001
R01DA047690 ( U.S. NIH Grant/Contract )
First Posted: December 6, 2019    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lofexidine
Clonidine
Antihypertensive Agents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sympatholytics
Autonomic Agents