Randomized, Double-blind, Active & Placebo-controlled, 6-way Crossover Study of Abuse Potential of Oral Gabapentin Enacarbil IR Capsules With and Without Oxycodone in Healthy, Nondependent, Recreational Opioid Users
Overview
- Phase
- Phase 4
- Intervention
- GE-IR 450 mg
- Conditions
- Abuse Potential
- Sponsor
- Arbor Pharmaceuticals, Inc.
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Drug Liking Visual Analog Scale (VAS)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to assess the abuse potential of gabapentin enacarbil immediate release capsules taken alone and in combination with oxycodone in healthy adult, non-dependent, recreational opioid users.
Detailed Description
The primary purpose of this study is to evaluate the abuse potential of gabapentin enacarbil immediate-release (GE-IR), the active moiety in Horizant, taken alone and taken in combination with oxycodone, compared to that of oxycodone alone. This study is a randomized, double-blind, active- and placebo-controlled, 6-way crossover design, aimed to assess the abuse potential, safety, and pharmacokinetics (PK) of GE-IR doses when administered alone or in combination with an opioid active control (oxycodone), and compared to placebo and oxycodone intake alone, in healthy, nondependent, recreational opioid users.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Provision of signed and dated informed consent form (ICF),
- •Stated willingness to comply with all study procedures and availability for the duration of the study,
- •Male or female, between 18 and 55 years of age, inclusive,
- •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,
- •Body mass index (BMI) within 18.0 kg/m2 to 36.0 kg/m2, inclusive,
- •If female, meets 1 of the following criteria:
- •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
Exclusion Criteria
- •History of significant hepatic, renal, cardiovascular, pulmonary, hematologic, neurological, psychiatric, gastrointestinal, endocrine, immunologic, ophthalmologic, or dermatologic disease of any etiology (including infections),
- •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,
- •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),
- •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),
- •History of sensitivity to or poor tolerance of gabapentin enacarbil, gabapentin, pregabalin, naloxone, or oxycodone,
- •Female who is lactating at screening,
- •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,
- •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,
- •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,
- •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),
Arms & Interventions
GE-IR 450 mg + Oxycodone 20 mg
oral doses given together
Intervention: GE-IR 450 mg
Placebo
oral masked Placebo
Intervention: Placebo
Oxycodone 20 mg
oral active control
Intervention: Oxycodone 20 mg
GE-IR 200mg
single oral dose
Intervention: GE-IR 200 mg
GE-IR 450 mg
single oral dose
Intervention: GE-IR 450 mg
GE-IR 200 mg + Oxycodone 20 mg
oral doses given together
Intervention: Oxycodone 20 mg
GE-IR 200 mg + Oxycodone 20 mg
oral doses given together
Intervention: GE-IR 200 mg
GE-IR 450 mg + Oxycodone 20 mg
oral doses given together
Intervention: Oxycodone 20 mg
Outcomes
Primary Outcomes
Drug Liking Visual Analog Scale (VAS)
Time Frame: approximately 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, and 24 hours postdose in the treatment phase and per period of the treatment phase
Mean difference in Drug Liking Emax over 24 hours for Drug Liking ("At this moment, my liking for this drug is"), assessed on a bipolar (0 to 100 points; 0: Strong disliking, 50: Neither like nor dislike, 100: Strong liking) VAS.
Secondary Outcomes
- Take Drug Again VAS(Approximately 12 and 24 hours postdose in the treatment phase and per period of the treatment phase)
- Overall Drug Liking VAS(Approximately 12 and 24 hours postdose in the treatment phase and per period of the treatment phase)
- High VAS(within 1 hour prior to and approximately 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, and 24 hours postdose in the treatment phase and per period of the treatment phase)