Nicotine Pharmacokinetics From Research Electronic Nicotine Delivery System S-TA-U001 in Smokers and E-Cigarette Users

Completed · Phase 1

Conditions studied: Cigarette Smoking

In brief

To better understand the PK and associated pharmacodynamic (PD) responses produced by the Research ENDS S-TA-U001 product, this study will compare the Research ENDS S-TA-U001 to * The subject's own brand combustion (non-menthol) cigarette and a U.S. FDA approved smoking cessation product, the NICORETTE Inhalator, in current non-menthol cigarette smokers who have some limited e-cigarette experience (Group 1). * Commercially available products in current primarily e-cigarette users (experienced ENDS users) (Group 2) The PK/PD session for each product will be conducted in a controlled clinical setting with frequent PK sampling after 14 hours of supervised abstinence from all forms of nicotine. Subjects will familiarize themselves with the Research ENDS S-TA-U001 and NICORETTE Inhalator by using each product in the real world for one day before the PK/PD session for that product. Primary Objectives: Group 1 objectives are to characterize the nicotine PK profile (eg, maximum plasma concentration \[Cmax\], time to maximum plasma concentration \[Tmax\], area under the concentration-time curve \[AUC\], and terminal half-life \[t1/2\]) for 10 inhalation and ad lib sessions of Research ENDS S-TA-U001 and explore how the Cmax compares to a 15 ng/mL level during the 4.5-minute 10 inhalation and the 6 hour ad lib use sessions, to compare the PK profiles between Research ENDS S-TA-U001 to the profiles of combustion cigarettes measured at the baseline session, and to demonstrate superiority of PK profile of Research ENDS S-TA-U001 to that of the marketed NICORETTE Inhalator. Group 2 objectives are to characterize the nicotine PK profile of Research ENDS S-TA-U001 and explore how the Cmax compares to a 15 ng/mL level during the 4.5-minute 10 inhalation and 6 hour ad lib use sessions, and to compare the PK profile between Research ENDS S-TA-U001 to the profile of a commercial ENDS product measured at the baseline session. Secondary objectives: Secondary objectives include comparison of the nicotine PK of the Research ENDS S-TA-U001 to the subjects' normal nicotine source (combustion cigarettes for Group 1 or commercial ENDS for Group 2), to evaluate the safety and tolerability of Research ENDS S-TA-U001, to evaluate the effects on craving and user satisfaction of the Research ENDS S-TA-U001 vs a combustion cigarette or the NICORETTE Inhalator (Group 1) or a commercial ENDS product (Group 2), and to evaluate various biomarkers following use of each test product.

Key facts

Study ID

NCT02792426

Run by

NJOY, Inc.

People needed

34

Starts

2016-10-05

Expected to finish

2017-06-01

Last updated by the study team

2018-05-17

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• For Group 1: in order to participate in the study, potential subjects must:
• Be males and females of any race between 21 and 65 years of age inclusive
• Be current combustion cigarette smokers, defined as smoking a minimum of 10 combustion cigarettes per day for a period of at least 3 months, who smoke commercial (non menthol) cigarettes
• Not be currently planning to quit smoking combustion cigarettes in the next 3 months
• Have blood cotinine ≥100 ng/mL and carbon monoxide ≥10 ppm at Screening to confirm smoking status
• Weigh at least 45 kg and have a Body Mass Index (BMI) between 18 and 40 kg/m2, inclusive, at Screening
• Be healthy, in the Investigator's opinion, according to medical history; physical examination; electrocardiogram (ECG); and clinical chemistry, urine, and hematological laboratory tests
• Be willing to refrain from using any source of nicotine other than study supplies for the duration of the study confinement period
• Have vital signs as follows:
• Resting heart rate between 50 and 90 beats per minute
• Systolic blood pressure below 150 mm Hg
• Diastolic blood pressure below 90 mm Hg
• Have electrolytes (ie, Na, K, Cl, HCO3) and hematocrit that are clinically normal (± 10% of laboratory limits); subjects marginally outside of this range may be eligible at the discretion of the study physician
• Have liver function tests (ie, total bilirubin, ALT, AST, GGT, and alkaline phosphatase) less than three times the upper normal limit
• Have kidney function tests (ie, creatinine and BUN) within clinically normal limits (± 10% of laboratory limits) and calculated creatinine clearance > 80 mL/min for females and > 90 mL/min for males
• Have an ECG performed that demonstrates normal sinus rhythm, normal conductivity, and no clinically significant abnormalities
• Be able to demonstrate the ability to comply with the inhalation instructions for Test Product administration (Research ENDS S TA U001 and NICORETTE Inhalator), visually confirmed by clinic staff at Screening visit
• Be able to verbalize understanding of the consent forms, provide written informed consent, and verbalize willingness to comply with the study procedure
• Have 5-50 days of use of any ENDS product in their life and no use within 7 days before Screening
• Have no more than 20 days of use of the NICOTROL Inhaler in their life and no use within the 7 days before Screening
• For Group 2: in order to participate in the study, potential subjects must:
• Be males and females between 21 and 65 years of age inclusive
• Be current daily users of a commercially available ENDS product, with e-liquids of nicotine concentration 10 to 20 mg/mL
• Consume at least 1 mL per day of e-liquid in their ENDS product
• Not smoke more than 2 combustion (non menthol) cigarettes per day

You may not qualify if…

• For Group 1 and Group 2: in order to participate in the study, potential subjects must not:
• Have expected inability to comply with study protocol
• Have used any of the following in the past 30 days: ultra-light, hand or roll-your-own, menthol, or unfiltered combustion cigarettes; any other form of tobacco (eg, chews, dips, pipes, cigars, hookah); or any form of nicotine replacement therapy (eg, patch, gum, lozenge, inhaler, nasal spray).
• Be pregnant (based on serum test) or nursing (by self-report)
• Have history or diagnosis of airway disease, including adult onset asthma or chronic obstructive pulmonary disease (including emphysema or chronic bronchitis), use of an inhaler (apart from a nicotine inhaler) in the previous 5 years, or any episodes of wheezing or bronchospasm in the previous 5 years (history of resolved childhood asthma is acceptable)
• Have baseline spirometry values (FEV1, FVC, and FEV1/FVC) outside of the lower limit of normal as defined by Hankinson et al, Am J Respir Crit Care Med 1999; 159:179-187.
• Have had treatment with prescription medications within 21 days or over-the-counter medication within 24 hours of the planned first product use occasion, except for oral or hormonal contraceptive therapies.
• Have used any drugs or substances (except tobacco) known to be strong inducers or inhibitors of any CYP enzymes (formerly known as cytochrome P450 enzymes) within a 28 days period prior to first product administration. For a list of such drugs and substances, please refer to http://medicine.iupui.edu/clinpharm/ddis/main-table/.
• Have an active cough, recent or chronic, excluding "smoker's cough"
• Have any active respiratory infection
• Have a history of clinically significant cardiac, pulmonary, renal, hepatic, endocrine, neurological, gastrointestinal, metabolic, psychiatric, or hematologic disorders
• Have poor venous access as defined by being unable to draw samples through a catheter at the screening visit
• Have been hospitalized within 4 weeks before Screening
• Have received any other investigational treatment or Test Product within 30 days from randomization (or within 5 half-lives of the Test Product, if known, whichever is greater)
• Have a history of allergic, anaphylactic, or other hypersensitivity reaction to any e cigarette , or any of the components associated with these products such as propylene glycol
• Have any medical history or condition (including physical) considered by the Principal Investigator and/or admitting physician to place the subjects at increased risk or preclude safe and/or successful completion of the study
• Have any history of substance abuse, including alcohol abuse within the last 3 months
• Have a positive result for any drug of abuse (opiates, benzodiazepines, barbiturates or related CNS depressants, amphetamines or related stimulants, or marijuana) at screening or Day -1
• Be cognitively impaired to a degree that would affect participation. An adequate level of reading and comprehension is needed in order to complete various forms (e.g., behavioural assessments) that are used as dependent variables
• Have active syphilis (based on the standard confirmatory test (e.g., FTB-abs))
• Be undergoing HIV treatment with antiviral and non-antiviral therapy or treatment for HIV-related opportunistic infection
• Do not actively meet the inclusion criteria at the time of screening

Where it is running

• LA Clinical Trials — Burbank, California, United States

Full record on ClinicalTrials.gov

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