CSD201002: Study to Assess Nicotine Uptake From P10 Nicotine Pouches
An In-Clinic Confinement Study to Assess Nicotine Uptake From P10 Nicotine Pouches
1 other identifier
interventional
36
1 country
1
Brief Summary
This study is a single-center, open-label, randomized, 7-way crossover study designed to evaluate plasma nicotine pharmacokinetics (PK) parameters following use of the study investigational products (IPs) in a confinement setting by generally healthy combustible cigarette (CC) smokers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2021
CompletedFirst Posted
Study publicly available on registry
October 18, 2021
CompletedStudy Start
First participant enrolled
October 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 24, 2021
CompletedJune 27, 2022
June 1, 2022
1 month
October 4, 2021
June 23, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
AUC nic 0-240
Baseline-adjusted area under the plasma nicotine concentration-versus-time curve from time zero to 240 minutes after the start of IP use
0 to 240 minutes
Cmax
Maximum baseline-adjusted plasma concentration of nicotine
240 minutes
Study Arms (14)
Product usage order A B G C F D E
EXPERIMENTALSubjects will use each of the 7 products (A B G C F D E) during an evaluation period, followed by a 4 hour Test Session
Product usage order B C A D G E F
EXPERIMENTALSubjects will use each of the 7 products (B C A D G E F) during an evaluation period, followed by a 4 hour Test Session
Product usage order C D B E A F G
EXPERIMENTALSubjects will use each of the 7 products (C D B E A F G) during an evaluation period, followed by a 4 hour Test Session
Product usage order D E C F B G A
EXPERIMENTALSubjects will use each of the 7 products (D E C F B G A) during an evaluation period, followed by a 4 hour Test Session
Product usage order E F D G C A B
EXPERIMENTALSubjects will use each of the 7 products (E F D G C A B) during an evaluation period, followed by a 4 hour Test Session
Product usage order F G E A D B C
EXPERIMENTALSubjects will use each of the 7 products (F G E A D B C) during an evaluation period, followed by a 4 hour Test Session
Product usage order G A F B E C D
EXPERIMENTALSubjects will use each of the 7 products (G A F B E C D) during an evaluation period, followed by a 4 hour Test Session
Product usage order E D F C G B A
EXPERIMENTALSubjects will use each of the 7 products (E D F C G B A) during an evaluation period, followed by a 4 hour Test Session
Product usage order F E G D A C B
EXPERIMENTALSubjects will use each of the 7 products (F E G D A C B) during an evaluation period, followed by a 4 hour Test Session
Product usage order G F A E B D C
EXPERIMENTALSubjects will use each of the 7 products (G F A E B D C) during an evaluation period, followed by a 4 hour Test Session
Product usage order A G B F C E D
EXPERIMENTALSubjects will use each of the 7 products (A G B F C E D) during an evaluation period, followed by a 4 hour Test Session
Product usage order B A C G D F E
EXPERIMENTALSubjects will use each of the 7 products (B A C G D F E) during an evaluation period, followed by a 4 hour Test Session
Product usage order C B D A E G F
EXPERIMENTALSubjects will use each of the 7 products (C B D A E G F) during an evaluation period, followed by a 4 hour Test Session
Product usage order D C E B F A G
EXPERIMENTALSubjects will use each of the 7 products (D C E B F A G) during an evaluation period, followed by a 4 hour Test Session
Interventions
P1012915, a nicotine pouch with 8 mg nicotine
P1013018, a nicotine pouch with 10 mg nicotine
P1013015, a nicotine pouch with 8 mg nicotine
P1012815, a nicotine pouch with 8 mg nicotine
P1013315, a nicotine pouch with 8 mg nicotine
P1013115, a nicotine pouch with 8 mg nicotine
P1013215, a nicotine pouch with 8 mg nicotine
Eligibility Criteria
You may qualify if:
- Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.
- Generally healthy males or females, 21 to 60 years of age, inclusive, at the time of consent.
- Smokes combustible, filtered, non-menthol or menthol cigarettes, 83 mm to 100 mm in length as primary source of tobacco.
- Smokers who also use ST products (e.g., moist snuff, snus), and have used ST within 30 days prior to screening will be enrolled.
- Smokes an average of at least 10 cigarettes per day (CPD) and inhale the smoke, for at least 6 months prior to Screening. Brief periods of abstinence due to illness, quit attempt (prior to 30 days of Screening), or clinical study participation (prior to 30 days of Screening) will be allowed at the discretion of the PI.
- Agrees to smoke the same Usual Brand (UB) cigarette throughout the study period. The UB cigarette is defined as the reported cigarette brand and style currently smoked most frequently by the subject.
- Expired breath carbon monoxide (ECO) level is ≥ 10 ppm and ≤ 100 ppm at Screening and at check-in Day 1.
- Positive urine cotinine test at Screening.
- Response at Screening to the Fagerström Test for Nicotine Dependence (FTND) Question 1 ("How soon after you wake up do you smoke your first cigarette?") is either "Within 5 minutes" or "6-30 minutes" (Heatherton et al., 1991).
- Willing to use the UB cigarette and Velo Pouch IPs during the study period.
- Willing to abstain from tobacco and nicotine use for at least 12 hours prior to the start of each of seven Test Sessions.
- Females must be willing to use a form of contraception acceptable to the PI from the time of signing the informed consent until End-of-Study.
- Examples of acceptable means of birth control are, but not limited to: a) Surgical sterilization (hysterectomy, bilateral tubal ligation/occlusion, bilateral oophorectomy, bilateral salpingectomy); b) physical barrier method (e.g., condom, diaphragm/sponge/cervical cap) with spermicide; c) non-hormone releasing intrauterine devices (IUD) or hormone-releasing IUDs (e.g., Mirena or Kyleena); d) vasectomized partner; and e) post-menopausal and not on hormone replacement therapy.
- Agrees to an in-clinic confinement of 8 days (7 nights).
You may not qualify if:
- Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of the PI, makes the study subject unsuitable to participate in this clinical study.
- History, presence of, or clinical laboratory test results indicating diabetes.
- Scheduled treatment for asthma currently or within the past consecutive 12 months prior to the Screening Visit. As-needed treatment, such as inhalers, may be included at the PI's discretion pending approval from the Medical Monitor.
- History or presence of bleeding or clotting disorders.
- Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that has been surgically and/or cryogenically removed.
- Systolic blood pressure of \> 160 mmHg or a diastolic blood pressure of \> 95 mmHg, measured after being seated for five minutes at Screening and at check-in Day 1.
- Weight of ≤ 110 pounds.
- Hemoglobin level is \< 12.5 g/dL for females or \<13.0 g/dL for males at Screening.
- Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
- A positive urine drug screen without evidence of prescribed corresponding concomitant medication(s) at Screening or check-in Day 1.
- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within (≤) 30 days prior to the signing of informed consent.
- Postpones a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or self-reports a previous quit attempt within (≤) 30 days prior to the signing the informed consent.
- Any use of daily aspirin (≥ 325 mg/day) or any use of other anticoagulants.
- Individuals ≥ 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AMR Knoxville
Knoxville, Tennessee, 37920, United States
Related Publications (1)
Kanobe MN, Powell CY, Patrudu M, Baxter SA, Tapia MA, Darnell J, Prevette K, Gibson AG, Ayoku SA, Campbell L, Coffield JW, Keyser BM, Ganesh BS, Gale N, Jordan KG. Randomized crossover clinical studies to assess abuse liability and nicotine pharmacokinetics of Velo Oral Nicotine pouches. Front Pharmacol. 2025 Mar 13;16:1547073. doi: 10.3389/fphar.2025.1547073. eCollection 2025.
PMID: 40183092DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Milly Kanobe, PhD
RAIS
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2021
First Posted
October 18, 2021
Study Start
October 20, 2021
Primary Completion
November 24, 2021
Study Completion
November 24, 2021
Last Updated
June 27, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share