| Eligibility |
Inclusion Criteria:
1. Provision of signed and dated informed consent form (ICF),
2. Stated willingness to comply with all study procedures and availability for the
duration of the study,
3. Male or female, between 18 and 55 years of age, inclusive,
4. Current nondependent, recreational opioid user who has used opioid drugs for
recreational (nontherapeutic) purposes (i.e., for psychoactive effects) at least 5
times in the subject's lifetime and at least once in the last 12 weeks,
5. Body mass index (BMI) within 18.0 kg/m2 to 36.0 kg/m2, inclusive,
6. If female, meets 1 of the following criteria:
1. If of childbearing potential agrees to use 1 of the accepted contraceptive
regimens from at least 30 days prior to the first study treatment administration,
during the study, and for at least 30 days after the last dose of the study
treatment. An acceptable method of contraception includes 1 of the following:
- Abstinence from heterosexual intercourse,
- Hormonal contraceptives (birth control pills,
injectable/implantable/insertable hormonal birth control products,
transdermal patch), or
- Intrauterine device (IUD; with or without hormones). Or
2. If of childbearing potential agrees to use a double barrier method (e.g., condom
and spermicide) during the study and for at least 30 days after the last dose of
study treatment.
Or
3. If of non-childbearing potential, defined as surgically sterile (i.e., has
undergone complete hysterectomy, bilateral oophorectomy or tubal ligation) or is
in a postmenopausal state (i.e., at least 1 year without menses without an
alternative medical condition and confirmed follicle stimulating hormone (FSH) =
40 milli-International unit (mIU)/mL prior to the first study treatment
administration),
7. If male and engaging in sexual activity that has the risk of pregnancy must agree to
use a double barrier method (e.g., condom and spermicide) and agree to not donate
sperm during the study and for at least 90 days after the last dose of study
treatment, a male who has a pregnant partner shall be excluded,
8. Healthy, as determined by no clinically significant findings from medical history,
physical examination, 12-lead ECG, vital signs or clinical laboratory (including
hematology, clinical chemistry, urinalysis, and serology [screening visit only]) at
screening visit and admission, in the opinion of an investigator.
9. Negative Covid-19 test prior to each admission.
Exclusion Criteria:
1. History of significant hepatic, renal, cardiovascular, pulmonary, hematologic,
neurological, psychiatric, gastrointestinal, endocrine, immunologic, ophthalmologic,
or dermatologic disease of any etiology (including infections),
2. Presence or history of significant gastrointestinal, liver or kidney disease, or
surgery that may affect drug bioavailability with the exception that cholecystectomy
is permitted at the discretion of an investigator,
3. Presence of any significant respiratory illness or presence or history of chronic
respiratory disease (e.g., upper respiratory illness, sleep apnea, emphysema, asthma)
at screening (subjects with acute respiratory illness may be rescheduled upon
resolution at the discretion of an investigator),
4. Personal or family history (first degree relatives) of allergy, hypersensitivity, or
drug rash with eosinophilia and systemic symptoms (DRESS) syndrome to gabapentin
enacarbil,gabapentin or any drug product including naloxone, opioids (e.g.,
oxycodone), or related drugs or known excipients of any of the drug products in this
study (e.g. lactose),
5. History of sensitivity to or poor tolerance of gabapentin enacarbil, gabapentin,
pregabalin, naloxone, or oxycodone,
6. Female who is lactating at screening,
7. Female who is pregnant according to the pregnancy test at screening or prior to the
first study treatment administration or planning to become pregnant within 30 days
following the last study treatment administration,
8. History of substance or alcohol dependence (excluding nicotine and caffeine) within
the past 2 years, as defined by the Diagnostic and Statistical Manual of Mental
Disorders, 4th Edition (DSM-IV), and/or subject has ever been in a drug or alcohol
rehabilitation program within the last 2 years,
9. Subjects with positive urine drug screen (UDS) results at screening and admission will
be assessed for inclusion at the discretion of an Investigator. If
tetrahydrocannabinol (THC) is positive at admission to the qualification phase and
treatment phase, a cannabis intoxication evaluation will be done by an investigator
and subjects may be permitted to continue in the study, rescheduled, or discontinued
at the discretion of an investigator. Other positive test results should be reviewed
to determine if the subject may be rescheduled, in the opinion of the investigator,
10. Is a heavy smoker (>20 cigarettes per day or nicotine-equivalent) and/or is unable to
abstain from smoking or unable to abstain from the use of prohibited
nicotine-containing products for at least 1 hour before and 6 hours after study
treatment administration (including e-cigarettes, pipes, cigars, chewing tobacco,
nicotine topical patches, nicotine gum, or nicotine lozenges),
11. Is a heavy opioid user and not likely to be sensitive to a 20 mg dose of oxycodone, in
the opinion of an investigator or designee,
12. Regularly consumes excessive amounts of caffeine or xanthines within 30 days prior to
screening, defined as greater than 6 servings (1 serving is approximately equivalent
to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day,
13. History of suicidal ideation or suicidal behaviour within 2 years of screening,
showing suicidal tendency as per the Columbia Suicide Severity Rating Scale (C-SSRS)
administered at screening, or is currently at risk of suicide in the opinion of an
investigator,
14. Presence of clinically significant ECG abnormalities at the screening visit, as
defined by medical judgment, Note: QT corrected according to Fridericia's formula
(QTcF) interval of >450 msec in male subjects or >470 msec in female subjects will be
exclusionary. The ECG may be repeated once for confirmatory purposes if the initial
value obtained exceeds the limits specified,
15. Has creatinine clearance =60ml/min as calculated by the Cockcroft-Gault equation,
16. Any history of tuberculosis,
17. Positive screening results to human immunodeficiency virus (HIV) 1 and 2 antibodies,
hepatitis B virus surface antigen (HBsAg) or hepatitis C virus antibody (HCVAb) tests,
18. Intake of an investigational product (IP) within 30 days or 5 times the half-life
(whichever is longer) prior to screening,
19. Use of any prescription drugs (with the exception of hormonal contraceptives or
hormone replacement therapy) in the 30 days prior to the first study treatment
administration, that in the opinion of an investigator would put into question the
status of the subject as healthy,
20. Use of over-the-counter (OTC) products (including herbal preparations and supplements)
within 7 days prior to the first study treatment administration, with the exception of
ibuprofen or acetaminophen,
21. Use of a prohibited medication as specified in section 4.7,
22. Donation of plasma in the 7 days prior to screening,
23. Blood donation (excluding plasma) of approximately 500 mL of blood in the 56 days
prior to screening,
24. Is, in the opinion of an investigator or designee, considered unsuitable or unlikely
to comply with the study protocol for any reason.
25. Poor venous access at screening, as judged by an investigator.
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