Altria’s Clinical Science team conducts studies in human volunteers (21+ and tobacco users) to assess pharmacokinetics, pharmacodynamics, tobacco constituent exposure and changes in potential indicators of disease risk during use of tobacco products to support the product applications we submit to the Food and Drug Administration (FDA).

studies in adult human subjects section title

As part of a comprehensive harm reduction strategy, Altria assesses human impact through clinical trials. This data not only helps us understand the reduced-risk potential of tobacco products, but it also helps us address FDA guidance for product applications or specific questions from FDA about our products.

 

 

Pharmacokinetic and Pharmacodynamic Studies

We conduct studies to understand the rate and overall uptake of nicotine (pharmacokinetics) from our tobacco products. Pharmacokinetic studies typically involve measuring nicotine blood levels over the course of a tobacco product use session. During these assessments, we also measure subjective responses about how the products are impacting tobacco cravings, the overall experience the participating adult smoker is having (pharmacodynamics). 

The combination of understanding the nicotine uptake and the overall experience is used to address abuse liability of the products, which is required by the FDA, and helps evaluate the potential for new products to replace cigarettes. 

 

JW Scientist callout

Meet Jingzhu Wang

Jingzhu is a member of the American Statistical Association and has more than 25 years of experience working on Phase I, II, III and IV clinical trials in the pharmaceutical and tobacco industries. Jingzhu’s recent work includes supporting abuse liability studies for the on! Premarket Tobacco Product Applications.
Our Progress
Since 2015:

49

conference presentations

9

publications in peer-reviewed journals

Read a recently published article:
A randomized, controlled, parallel group clinical study of cigarette smokers using an innovative oral tobacco-derived nicotine product to determine impact on cigarette consumption and biomarkers of exposure.

Review a recent poster presentation:
Characterization of Nicotine Pharmacokinetics from on!® Nicotine Pouches in Adult Smokers". 

1.  Altria has an 80% interest in Helix Innovations, LLC, provider of on! nicotine pouches.
2.  Altria has an agreement with PMI to sell IQOS products in the United States.
3.  Altria has a 35% economic interest in JUUL, the U.S. leader in e-vapor.