Pharmacokinetic and Subjective Effects of Heated Tobacco Products (NCT06356610) | Clinical Trial Compass
CompletedNot Applicable
Pharmacokinetic and Subjective Effects of Heated Tobacco Products
United States80 participantsStarted 2024-02-06
Plain-language summary
This is a randomized, controlled, six-way crossover clinical study to characterize the nicotine PK (pharmacokinetic) and subjective effects of HTPs (Heated Tobacco Products) comprised of 2 menthol varieties and 2 tobacco flavor varieties (Ploom® HTPs, Japan Tobacco Inc.) in adult menthol and non-menthol combustible cigarette smokers (males and females between the ages of 22 and 65). The study will include participants' UBCC (Usual Brand Combustible Cigarette) and a nicotine gum (Nicorette®) as high and low abuse liability reference products, respectively, to the HTP. Study participation is expected to last up to 34 days, including a 28-day screening period (that includes a 5-day at-home HTP product trial period), and a 6-day in-clinic confinement period (from Check-in \[Day -1\] through the end-of-study \[EOS\] visit on Day 6).
Who can participate
Age range22 Years – 65 Years
SexALL
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Inclusion criteria
✓. Participants must be informed of the nature and risks of the study and voluntarily give written informed consent prior to screening.
✓. Healthy adult males and females ≥ 22 and ≤ 65 years of age, inclusive, at screening.
✓. Participants must self-report currently smoking menthol or non-menthol factory manufactured combustible cigarettes. Participants will have a history of smoking ≥ 10 to
Exclusion criteria
✕. Participants must be generally healthy, free of lifetime malignant tumors, and without clinically significant abnormalities as assessed by the Investigator based on the review of medical and surgical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluations conducted at screening and Check-in, as applicable (refer to Table 1). A single repeat measurement/test may be performed to confirm vital signs, 12-lead ECG, and clinical laboratory tests abnormalities (i.e., to confirm that a participant is eligible).
✕. Screening and Check-in systolic/diastolic blood pressure ≤ 150/90 mmHg measured after being seated quietly for at least 10 minutes. Two rechecks may be performed at the Investigator's discretion.
✕. Exhaled carbon monoxide ≥ 10 ppm at screening.
✕. Negative pregnancy test at screening and Check-in (Day -1) for all female participants.
✕. Female participants who are sexually active and of childbearing potential (i.e., not surgically sterile at least 6 months prior to Check-in nor post-menopausal with amenorrhea for at least 1 year prior to Check-in and FSH levels consistent with postmenopausal status) must not be lactating and must have been using one of the following forms of contraception from 3 months before first study product administration through 30 days after the final administration of study product:
✕0. Female participants who are of non-childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to Check-in:
✕1. Able to communicate effectively with the study personnel and willing to comply with the requirements of the study.