CSD231005 Nicotine Pouch Biomarkers of Exposure

NCT06303115 | Completed

• 1 other identifier: CSD231005 BoE
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 5

Brief Summary

This will be a multi center open label, randomized, controlled, switching parallel-group study designed to assess changes in select biomarkers of exposure (BoE) in generally healthy smokers following a 5 day in-clinic switch to use of nicotine Pouch investigational products (IPs) compared to continued usual brand (UB) cigarette smoking or smoking abstinence.

Conditions

Tobacco Use; Smoking

Outcome Measures

Primary Outcomes (1)

• 4(methylnitrosamino)1(3pyridyl)1butanol [NNAL] + glucuronides [Total NNAL]

  24 hour

Secondary Outcomes (14)

• 4Aminobiphenyl [4ABP]

  24 hour

• 1Aminonaphthalene [1AN]

  24 hour

• 2Aminonaphthalene [2AN]

  24 hour

• 2Cyanoethyl mercapturic acid [CEMA]

  24 hour

• 3Hydroxypropyl mercapturic acid [3HPMA]

  24 hour

Study Arms (7)

Nicotine Pouch P1312914, 4 mg nicotine

ACTIVE COMPARATOR

Subjects will be switched to exclusive use of their assigned pouch flavor and strength.

Other: Nicotine Pouch P1312914, 4 mg nicotine

Nicotine Pouch P1312915, 8 mg nicotine

ACTIVE COMPARATOR

Subjects will be switched to exclusive use of their assigned pouch flavor and strength.

Other: Nicotine Pouch P1312915, 8 mg nicotine

Nicotine Pouch P1013215, 8 mg nicotine

ACTIVE COMPARATOR

Subjects will be switched to exclusive use of their assigned pouch flavor and strength.

Other: Nicotine Pouch P1013215, 8 mg nicotine

Nicotine Pouch P1013218, 10 mg nicotine

ACTIVE COMPARATOR

Subjects will be switched to exclusive use of their assigned pouch flavor and strength.

Other: Nicotine Pouch P1013218, 10 mg nicotine

Nicotine Pouch P1012919, 12 mg nicotine

ACTIVE COMPARATOR

Subjects will be switched to exclusive use of their assigned pouch flavor and strength.

Other: Nicotine Pouch P1012919, 12 mg nicotine

Smoking Abstinence

OTHER

Subjects will not use any tobacco or nicotine containing products.

Other: Smoking Abstinence

Continued UB cigarette smoking

OTHER

Subjects will continue use of their Usual Brand Cigarettes.

Other: Continued UB cigarette smoking

Interventions

Nicotine Pouch P1312914, 4 mg nicotine OTHER

P1312914 pouch product

Nicotine Pouch P1312914, 4 mg nicotine

Nicotine Pouch P1312915, 8 mg nicotine OTHER

P1312915 pouch product

Nicotine Pouch P1312915, 8 mg nicotine

Nicotine Pouch P1013215, 8 mg nicotine OTHER

P1013215 pouch product

Nicotine Pouch P1013215, 8 mg nicotine

Nicotine Pouch P1013218, 10 mg nicotine OTHER

P1013218 pouch product

Nicotine Pouch P1013218, 10 mg nicotine

Nicotine Pouch P1012919, 12 mg nicotine OTHER

P1012919 pouch product

Nicotine Pouch P1012919, 12 mg nicotine

Smoking Abstinence OTHER

No tobacco/nicotine

Smoking Abstinence

Continued UB cigarette smoking OTHER

Usual Brand Cigarette

Continued UB cigarette smoking

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to read, understand, and be 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, nonmenthol or menthol cigarettes, 83 mm to 100 mm in length.
• Smokes an average of at least 10 cigarettes per day (CPD) and inhales the smoke for at least six months prior to Screening. Brief periods of abstinence due to illness, a 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.
• Self-reports that cigarettes are their primary tobacco- or nicotine-containing product use within 30 days of Screening. (Note: occasional use of other tobacco- or nicotine-containing products may be acceptable in consultation with the Sponsor);
• Agrees to use assigned IP throughout the study period.
• Expired breath carbon monoxide (ECO) level ≥ 10 ppm and ≤ 100 ppm at Screening and at CheckIn on Day 2.
• 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 "630 minutes." (Heatherton, Kozlowski, Frecker, \& Fagerstrom, 1991).
• Willing to switch from current UB cigarette to either nicotine Pouch IP, or abstain from smoking, for approximately 5 days during in-clinic confinement;
• Females must be willing to use a form of contraception acceptable to the PI from the time of signing the informed consent until the End of Study (EOS).
• Examples of acceptable means of birth control are, but not limited to:
• Surgical sterilization (hysterectomy, bilateral tubal ligation/occlusion, bilateral oophorectomy, bilateral salpingectomy);
• Established use of oral, implantable, injectable or transdermal methods of contraception associated with inhibition of ovulation (see Section 6.10 regarding the use of hormonal methods of contraception in females aged ≥ 35);
• Physical barrier method (e.g., condom, diaphragm/sponge/cervical cap) with spermicide;

You may not qualify if:

• The 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 subject unsuitable to participate in this clinical study.
• Scheduled treatment for asthma currently or within the past 12 consecutive months prior to Screening. As needed treatment, such as inhalers, may be included at the PI's discretion, pending approval from the Medical Monitor.
• Use of any medications that interfere with the cyclooxygenase pathway (e.g., antiinflammatoryanti-inflammatory drugs such as aspirin and ibuprofen) 14 days prior to CheckIn on Day 2.
• Use of medications or substances (other than nicotine) known to be strong inducers or inhibitors of cytochrome P450 (CYP) enzymes within 14 days or 5 halflives of the medication or substances (whichever is longer) prior to CheckIn on Day 2.
• History or presence of bleeding or clotting disorders.
• Any history of cancer, except for primary cancers of the skin, such as localized basal cell/squamous cell carcinoma, that have been surgically and/or cryogenically removed.
• Systolic blood pressure (BP) of \> 160 mmHg or a diastolic BP of \> 95 mmHg, measured after being seated for 5 minutes at Screening and CheckIn on Day 2.
• Body Mass Index (BMI) \< 18.0 or \>40.0 kg/m2 (weight of ≤ 110 pounds) at Screening.
• Hemoglobin level \< 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 CheckIn on Day 2.
• Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBbsAg), or hepatitis C virus (HCV).
• Use of any medication or substance that aids in smoking cessation, including but not limited to any NRT (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within (≤) 30 days prior to signing of the ICF.
• Postpones a decision to quit using tobacco or nicotinecontaining products to participate in this study or has made a previous quit attempt within (≤) 30 days prior to the signing of the ICF.
• Any daily use of aspirin (≥ 325 mg/day) or anticoagulants (e.g., Clopidogrel \[Plavix®\], Warfarin \[Coumadin®, Jantoven®\]).

Sponsors & Collaborators

• RAI Services Company: lead

Study Sites (5)

Pillar Bentonville

Bentonville, Arkansas, 72712, United States

Location

AMR Lexington

Lexington, Kentucky, 40509, United States

Location

QPS Missouri

Springfield, Missouri, 65802, United States

Location

AMR Knoxville

Knoxville, Tennessee, 37920, United States

Location

Pillar Richardson

Richardson, Texas, 75080, United States

Location

MeSH Terms

Conditions

Tobacco Use; Smoking

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Brian Keyser, PhD

  Reynolds American

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: August 22, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: April 11, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)