United States Pre-Market Tobacco Application Pharmacokinetics (US-PMTA-PK)

Juul Labs

Status: Completed

Conditions: Nicotine Dependence; Tobacco Smoking; Nicotine Dependence, Cigarettes; Tobacco Use

Treatments: Other: Virginia Tobacco flavored JUUL 5% ENDS; Other: Creme Brulee flavored JUUL 5% ENDS; Other: Mango flavored JUUL 5% ENDS; Other: Nicorette White Ice Mint 4mg nicotine polacrilex gum; Other: Cool Mint flavored JUUL 5% ENDS; Other: Usual Brand combustible cigarette; Other: VUSE Solo e-cigarette

Study type: Interventional

Funder types: Industry

Identifiers

NCT03719391

PROT-00009

Details and patient eligibility

About

A Randomized, Open-Label, Cross-Over Study to Assess Nicotine Uptake and Subjective Measures with Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) Compared to Usual Brand Combustible Cigarettes, a Comparator E-Cigarette, and Nicotine Gum in Healthy Adult Smokers

Full description

E-cigarettes may be an acceptable alternative to traditional cigarette smoking. In utilizing vaporization rather than combustion, the generation and inhaltion of smoke and carbon monoxide (CO) may be reduced or avoided. JUUL has developed several nicotine based liquid blends for use in e-cigarettes. This study will assess nicotine uptake during a 10-puff controlled and a 5-minute ad libitum use of four JUUL 5% electronic nicotine delivery systems (ENDS) relative to usual brand (UB) combustible cigarettes, a comparator electronic cigarette (e-cigarette), and nicotine gum.

Enrollment: 67 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy, adult, male or female smoker, 21 to 65 years of age, inclusive
• Has been a smoker for at least 12 months prior to Screening. Brief periods of non-smoking (e.g., up to ~7 consecutive days due to illness, trying to quit, participation in a study where smoking was prohibited) during that time will be permitted at the discretion of the PI.
• Currently smokes an average of 10 or more king size or 100s manufactured combustible CPD, as reported at Screening.
• Has a positive urine cotinine (≥ 500 ng/mL) at Screening
• Has an exhaled CO > 12 ppm at Screening.
• Is willing to comply with the requirements of the study, including a willingness to use the study products during the study.

Exclusion criteria

• Has a history or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or any other condition that, in the opinion of the PI, would jeopardize the safety of the subject or impact the validity of the study results.
• Has a clinically significant abnormal finding on the physical examination, medical history, vital signs, ECG, or clinical laboratory results, in the opinion of the PI.
• Has a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at Screening.
• Has had an acute illness (e.g., upper respiratory infection, viral infection) requiring treatment within 14 days prior to Check-in.
• Has a fever (> 100.5°F) at Screening or Check-in.
• Has a body mass index (BMI) > 40.0 kg/m2 or < 18.0 kg/m2 at Screening.
• Has a history of drug or alcohol abuse within 24 months of Check-in, as determined by the PI.
• Has diabetes mellitus, asthma, or chronic obstructive pulmonary disease.
• Has a systolic blood pressure < 90 mmHg or > 150 mmHg, diastolic blood pressure < 40 mmHg or > 95 mmHg, or heart rate < 40 bpm or > 99 bpm at Screening.
• Has experienced an allergic reaction following previous e-cigarette use or with exposure to any primary components of the e-liquids (benzoic acid, propylene glycol and glycerol).
• Has an estimated creatinine clearance < 80 mL/minute (using the Cockcroft-Gault equation) at Screening.
• Has a positive urine screen for alcohol or drugs of abuse at Screening or Check-in.
• Has used medications known to interact with cytochrome P450 (CYP) 2A6 (including, but not limited to, amiodarone, amlodipine, amobarbital, buprenorphine, clofibrate, clotrimazole, desipramine, disulfiram, entacapone, fenofibrate, isoniazid, ketoconazole, letrozole, methimazole, methoxsalen, metyrapone, miconazole, modafinil, orphenadrine, pentobarbital, phenobarbital, pilocarpine, primidone, propoxyphene, quinidine, rifampicin, rifampin, secobarbital, selegiline, sulconazole, tioconazole, tranylcypromine) within 14 days or 5 half-lives of the drug, whichever is longer, prior to Check-in.
• Has used nicotine-containing products other than manufactured cigarettes (e.g., ENDS, roll-your-own cigarettes, bidis, snuff, nicotine inhaler, pipe, cigar, chewing tobacco, nicotine patch, nicotine spray, nicotine lozenge, or nicotine gum) within 14 days prior to Check-in.
• Has a prior history of JUUL product use prior to Screening
• Has used any prescription smoking cessation treatments, including, but not limited to, varenicline (Chantix®) or buproprion (Zyban®) within 3 months prior to Check-in.
• Is a self-reported puffer (i.e., adult smokers who draw smoke from the cigarette into the mouth and throat but do not inhale).
• Is planning to quit smoking during the study or postponing a quit attempt in order to participate in the study.
• Has donated plasma within 7 days prior to Check-in.
• Has donated blood or blood products (with the exception of plasma as noted above), had significant blood loss, or received whole blood or a blood product transfusion within 56 days prior to Check-in.
• Has participated in a previous clinical study for an investigational drug, device, biologic, or tobacco product within 30 days prior to Check-in.
• Is or has a first-degree relative (i.e., parent, sibling, child) who is a current employee of the study site.
• Is or has a first-degree relative (i.e., parent, sibling, child) who is a current employee, shareholder, or is member of the board of directors of JUUL Labs Inc.
• Has previously been diagnosed with any form of cancer, except for basal cell or squamous epithelial carcinomas of the skin that have been resected at least 1 year prior to Screening.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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67 participants in 7 patient groups

JUUL 5% Virginia Tobacco ENDS

Experimental group

Description:

Treatment with JUUL Virginia Tobacco flavored 5.0% ENDS product.

Treatment:

Other: Virginia Tobacco flavored JUUL 5% ENDS

JUUL 5% Cool Mint ENDS

Experimental group

Description:

Treatment with JUUL Cool Mint flavored 5.0% ENDS product.

Treatment:

Other: Cool Mint flavored JUUL 5% ENDS

JUUL 5% Mango ENDS

Experimental group

Description:

Treatment with JUUL Mango flavored 5.0% ENDS product.

Treatment:

Other: Mango flavored JUUL 5% ENDS

JUUL 5% Creme Brulee ENDS

Experimental group

Description:

Treatment with JUUL Creme Brulee flavored 5.0% ENDS product.

Treatment:

Other: Creme Brulee flavored JUUL 5% ENDS

VUSE Solo e-cigarette

Active Comparator group

Description:

Treatment with VUSE Solo Original with 4.8% nicotine product.

Treatment:

Other: VUSE Solo e-cigarette

Nicotine Gum

Active Comparator group

Description:

Treatment with nicorette white ice mint 4mg nicotine polacrilex gum product.

Treatment:

Other: Nicorette White Ice Mint 4mg nicotine polacrilex gum

Usual Brand Combustible Cigarette

Active Comparator group

Description:

Treatment with usual brand combustible cigarette.

Treatment:

Other: Usual Brand combustible cigarette