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NCT06356610 · ClinicalTrials.gov registry record · NA
Pharmacokinetic and Subjective Effects of Heated Tobacco Products
A NA study, sponsored by Altria Client Services.
- Completed
- Registry status
- NA
- Development phase
- 80
- Enrollment target
NCT06356610: Completed NA study, sponsored by Altria Client Services.
NCT06356610 is a NA study that has completed, run by Altria Client Services. The registered enrollment target is 80 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06356610, a NA study, has completed, sponsored by Altria Client Services.
- COMPLETED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
Study 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).
Primary Outcome
Characterize PK parameters of nicotine in plasma during and after a single ad libitum use of HTP (two menthol and two tobacco flavor varieties) test products relative to UBCC and the nicotine gum reference products. Cmax: Maximum measured plasma concentration over the duration of the measurement interval from time zero (defined as the start of product use) to 180 minutes post-use on each Study Day 1 through Day 6.
Interventions
- OTHER Product A
- OTHER Product B
- OTHER Product C
- OTHER Product D
- OTHER Product E
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2024-02-06 |
| Est. Completion | 2024-12-18 |
| Phase | NA |
What the finished NCT06356610 record still lists
NCT06356610 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 5 interventions - of which Product A is the first listed.
NCT06356610 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06356610 about?
NCT06356610 is a clinical study titled "Pharmacokinetic and Subjective Effects of Heated Tobacco Products". 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-men...
What is the current status of trial NCT06356610?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2024-02-06. Estimated completion is 2024-12-18.
What interventions are being tested in trial NCT06356610?
The interventions under investigation include: Product A (OTHER), Product B (OTHER), Product C (OTHER), Product D (OTHER), Product E (OTHER).
Who is sponsoring clinical trial NCT06356610?
This trial is sponsored by Altria Client Services, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06356610's enrollment target sits among peer trials
80 994th of 2000 higher than 941 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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