An Abuse Potential Study of Orally Administered HORIZANT in Healthy, Non-dependent, Recreational Drug Users

NCT06097676 | Completed Phase 4 Results FDA Drug

• 1 other identifier: AR26.3031.1
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the abuse potential of gabapentin enacarbil in healthy adult, non-dependent, recreational drug users.

Conditions

Abuse Potential

Outcome Measures

Primary Outcomes (1)

• Drug Liking "at This Moment" Visual Analog Scale (VAS)

  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.

  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

Secondary Outcomes (3)

• Overall Drug Liking VAS

  approximately 12 and 24 hours postdose in the treatment phase and per period of the treatment phase

• Take Drug Again 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

Study Arms (5)

Placebo

PLACEBO COMPARATOR

\- Single oral dose

Drug: Placebo

Alprazolam 2 mg

ACTIVE COMPARATOR

* Single oral dose * Drug: Alprazolam 2 mg capsule

Drug: Alprazolam 2 mg

GE-IR 200 mg

EXPERIMENTAL

* Single oral dose * Drug: GE-IR 200 mg capsule

Drug: Gabapentin Enacarbil Immediate Release (GE-IR) 200 mg

GE-IR 450 mg

EXPERIMENTAL

* Single oral dose * Drug: GE-IR 450 mg capsule

Drug: Gabapentin Enacarbil Immediate Release (GE-IR) 450 mg

GE-IR 700 mg

EXPERIMENTAL

* Single oral dose * Drug: GE-IR 700 mg capsule

Drug: Gabapentin Enacarbil Immediate Release (GE-IR) 700 mg

Interventions

Placebo DRUG

Placebo

Placebo

Alprazolam 2 mg DRUG

Oral dose of alprazolam 2 mg

Also known as: Xanax

Alprazolam 2 mg

Gabapentin Enacarbil Immediate Release (GE-IR) 200 mg DRUG

Oral dose of GE-IR 200 mg

Also known as: Horizant

GE-IR 200 mg

Gabapentin Enacarbil Immediate Release (GE-IR) 450 mg DRUG

Oral dose of GE-IR 450 mg

Also known as: Horizant

GE-IR 450 mg

Gabapentin Enacarbil Immediate Release (GE-IR) 700 mg DRUG

Oral dose of GE-IR 700 mg

Also known as: Horizant

GE-IR 700 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 drug user who has used sedative drugs for recreational (nontherapeutic) purposes (i.e., for psychoactive effects) at least 10 times in the subject's lifetime and at least once in the 12 weeks before screening,
• Body mass index (BMI) within 18.0 kg/m\^2 to 36.0 kg/m\^2, 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 drug administration, during the study, and for at least 30 days after the last dose of the study drug. 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),
• Intrauterine device (IUD; with or without hormones), Or
• 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 drug. Or
• 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/mL (mIU/mL) prior to the first study drug administration),
• 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 the study medication, a male who has a pregnant partner shall be excluded,
• 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, as applicable, in the opinion of an investigator,
• Negative Coronavirus disease 2019 (Covid-19) test prior to each admission, as applicable.

You may not qualify if:

• 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 anti-convulsants (e.g., alprazolam, carbamazepine) or related drugs (e.g., other benzodiazepines) 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, or alprazolam,
• Female who is lactating at screening,
• Female who is pregnant according to the pregnancy test at screening or prior to the first study drug administration or planning to become pregnant within 30 days following the last study drug 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 been in a drug or alcohol rehabilitation program within the last 2 years,
• 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 drug administration (including e-cigarettes, pipes, cigars, chewing tobacco, nicotine topical patches, nicotine gum, or nicotine lozenges),
• 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,
• History of suicidal ideation within 24 months 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,
• Has creatinine clearance ≤60 ml/min as calculated by the Cockcroft-Gault equation,
• Any history of tuberculosis,
• Positive screening results to human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B virus surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) tests,
• Intake of an investigational product (IP) within 30 days or 5 times the half-life (whichever is longer) prior to screening,

Sponsors & Collaborators

• Arbor Pharmaceuticals, Inc.: lead

Study Sites (1)

Altasciences Clinical Kansas

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Interventions

Alprazolam; 1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid; Gabapentin

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: David Sequeira
• Organization: Azurity Pharmaceuticals, Inc.

david.sequeira@azurity.com

(913) 389-7961

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 24, 2023
• Study Start: September 28, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 12, 2024
• Results First Posted: January 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)