| Eligibility |
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), respiratory disorders, congenital long QT syndrome,
diabetes, 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. Ingestion of grapefruit-containing food or beverages (e.g., Fresca®) within 7 days
before dosing.
12. Drug or alcohol addiction requiring treatment in the 12 months before initial dosing.
13. History of excessive alcohol consumption (on average more than 14 units of
alcohol/week) during the past 12 months.
14. Positive test results for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
15. Positive test results for drugs of abuse (benzodiazepines, cocaine, cannabinoids/THC,
opiates and at screening only: amphetamines, barbiturates, methadone and
phencyclidine).
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