A Study to Assess the Pharmacokinetics of Oral Nicotine Pouches and Lozenges in Healthy Adults
A Single Dose, Randomised, Crossover Study to Assess the Pharmacokinetics of Oral Nicotine Pouches and Lozenges in Healthy Adults
1 other identifier
interventional
36
1 country
1
Brief Summary
This is a randomised, open-label, confined, cross-over study to evaluate the nicotine pharmacokinetics (PK) of modern oral nicotine pouches and nicotine lozenges carried out in 36 healthy adult subjects who smoke cigarettes and who may have experience using smokeless tobacco (loose or pouches).
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 Feb 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
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2021
CompletedFirst Posted
Study publicly available on registry
February 16, 2021
CompletedStudy Start
First participant enrolled
February 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2021
CompletedMarch 30, 2021
March 1, 2021
1 month
February 11, 2021
March 29, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Cmax
Maximum baseline-adjusted plasma concentration of nicotine
240 minutes
AUC0-240 mins
Baseline-adjusted area under the plasma nicotine concentration-versus-time curve from time zero to 240 minutes after the start of IP use
0-240 minutes
Study Arms (6)
Product usage order ABFCED
EXPERIMENTALSubjects will use each of the 6 products (ABFCED) during an familiarization period, followed by a 4 hour Test Session
Product usage order BCADFE
EXPERIMENTALSubjects will use each of the 6 products (ABECD) during an familiarization period, followed by a 4 hour Test Session
Product usage order CDBEAF
EXPERIMENTALSubjects will use each of the 6 products (CDBEAF) during an familiarization period, followed by a 4 hour Test Session
Product usage order DECFBA
EXPERIMENTALSubjects will use each of the 6 products (DECFBA) during an familiarization period, followed by a 4 hour Test Session
Product usage order EFDACB
EXPERIMENTALSubjects will use each of the 6 products (EFDACB) during an familiarization period, followed by a 4 hour Test Session
Product usage order FAEBDC
EXPERIMENTALSubjects will use each of the 6 products (FAEBDC) during an familiarization period, followed by a 4 hour Test Session
Interventions
A 4mg nicotine pouch product
A 4mg nicotine pouch product
A 2mg nicotine lozenge product
A 2mg nicotine lozenge product
A 2mg nicotine lozenge product
A 2mg nicotine lozenge product
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.
- Smoke manufactured combustible, filtered, non-menthol or menthol cigarettes, 83 mm to 100 mm in length as primary source of tobacco.
- Smokers who self-report use of a smokeless tobacco product (loose or pouch) prior to screening may also 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 an investigator.
- 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. If a subject reports use of a different UB cigarette at check in, that subject may continue provided they use that same UB cigarette throughout the study.
- Expired breath carbon monoxide (ECO) level is ≥ 10 ppm and ≤ 100 ppm at screening.
- Positive urine cotinine test at screening.
- Willing to use the UB cigarette and nicotine pouch or lozenge IPs during the study period.
- Willing to abstain from tobacco and nicotine use for at least 12 hours prior to start of each of six test sessions.
- If female and of non-childbearing potential, must meet one of the following criteria:
- Surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation/occlusion); or
- In a menopausal state (at least 1 year without menses), as confirmed by follicle stimulating hormone (FSH) levels (≥40 mIU/mL).
- If female and of childbearing potential, must agree to use one of the accepted contraceptive regimens from at least 30 days prior to the first administration of the IP during the study, and for at least 30 days after the last dose of the IP. An acceptable method of contraception includes one of the following:
- Abstinence from heterosexual intercourse;
- +4 more criteria
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 an investigator, 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 an investigator'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.
- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- Self reports use of the study IP (nicotine pouches or lozenges) currently or in the past.
- Recreationally uses vapor products (e.g., e-cigarettes, tank systems) more than one day per week, for the past 6 months prior to screening.
- Current, regular user (i.e., \> 5 times per month) of any tobacco products other than combustible cigarettes or smokeless tobacco within the last 6 months prior to screening.
- Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy (NRT) (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 attempt within (≤) 30 days prior to the signing the informed consent.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, 66212, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Debra Kelsh, MD
Altasciences Clinical Kansas, Inc.
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
February 11, 2021
First Posted
February 16, 2021
Study Start
February 18, 2021
Primary Completion
March 20, 2021
Study Completion
March 25, 2021
Last Updated
March 30, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share