Tobacco UseNCT04846088

A Study to Characterize Nicotine Pharmacokinetics and Subjective Effects of Nicotine Pouches in Adult Cigarette Smokers

A study testing Product A, Product B and Product C in people with Tobacco Use and Tobacco Smoking, run by British American Tobacco (Investments) Limited at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is designed to evaluate plasma nicotine pharmacokinetic (PK) parameters following the use of nicotine pouches in cigarette smokers who have experience with use of smokeless tobacco (SST) [e.g., snus, moist snuff]. Read more about this study

Who is it for?: Ages 22 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Tobacco Use, Tobacco Smoking
What is being tested?: Product A, Product B and Product C
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteUnited States
Study dates: 5 Apr 2021to 2 Jun 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Able to read, understand, and willing to sign an informed consent form (ICF) and complete the questionnaire written in English.
Generally healthy males or females, 22 to 65 years of age, inclusive, at the time of consent.
Body mass index (BMI) within 18.0 to 40.0 kg/m2, inclusive (minimum weight of at least 50.0 kg) at Screening.
Healthy, as determined by no clinically significant medical history, physical examination, 12-lead ECG, vital signs, or laboratory (including hematology, clinical chemistry, urinalysis, and serology) findings at Screening, as judged by the PI or designee.
Smoke combustible, filtered, non-menthol or menthol cigarettes, 83 mm to 100 mm in length as the primary source of tobacco use.
Self-reported use of smokeless tobacco (ST) products (e.g., moist snuff, snus) at least 1 to 2 times in the subject's lifetime prior to screening.

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Smokes an average of at least 10 cigarettes per day (CPD) and inhale the smoke, for at least 1 year 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 or designee.
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.
Positive urine cotinine test (≥ 200 ng/mL) at Screening.
Willing to use the IPs during the study period.
Willing to abstain from tobacco and nicotine use for at least 12 hours prior to start of each of nine 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 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 study medication. An acceptable method of contraception includes one of the following:
Abstinence from heterosexual intercourse;
Non-hormonal releasing intrauterine device;
Use of a double barrier method (e.g., condom and spermicide) during the study and for at least 30 days after the last dose of the study medication;
For females of < 35 years old only: Hormonal releasing intrauterine device; or
For females of < 35 years old only: Hormonal contraceptives (e.g., oral/transdermal patch/injectable/implant hormonal birth control products).
Agrees to an in-clinic confinement of at least 10 days (9 nights).
Must be willing to comply with the requirements and restrictions of the study.

Who cannot join

Inability to tolerate at least one 7 mg nicotine pouch for at least 45 minutes during the Product Familiarization Period at Check-in.
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 or designee, 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 or designee discretion pending approval from the Medical Monitor.
History or presence of bleeding or clotting disorders.
Presence of gum bleeding and/or abscess, open mouth sores or oral ulcers at Screening or Check-in.

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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.
Clinically significant abnormal findings on the vital signs, physical and oral examinations, medical history, or clinical laboratory results, in the opinion of the PI or designee.
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.
History of severe allergic reaction (including anaphylaxis) to any substance, previous status asthmaticus, food allergies/intolerances/restrictions (including mint, wintergreen or spearmint flavoring), or special dietary needs which, in the judgment of the PI or designee, would contraindicate the subject's participation in the study.
Requires concomitant treatment with prescription or non-prescription products that contain pseudoephedrine (e.g., nasal/sinus decongestants).
Has used medications known to interact with cytochrome P450 2A6 (including, but not limited to, amiodarone, desipramine, isoniazid, ketoconazole, miconazole, phenobarbital, rifampin, tranylcypromine, methoxsalen) within (≤) 3 months prior to Check-in and throughout the study.
Hemoglobin level is < 12.5 g/dL for females or < 13.0 g/dL for males at Screening.
Females who, at Screening or Check-in, 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.
Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at Screening.
Self-reported use of any the study IP currently or in the past.
Current, regular user (i.e., > 5 times per month) of any tobacco products other than combustible cigarettes or ST within (≤) 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 (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.
Any use of aspirin (≥ 325 mg/day) or anticoagulants within (≤) 30 days prior to the signing the informed consent.
Individuals ≥ 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy within (≤) 30 days prior to the signing the informed consent.
Whole blood donation within (≤) 8 weeks (≤ 56 days) prior to the signing of informed consent and between Screening and Check-in.
Plasma donation within (≤) 7 days prior to the signing of informed consent and between Screening and Check-in.
Employed by a tobacco or nicotine company, the study site, or handles tobacco- or nicotine-containing products as part of their job.
Participation in another clinical trial within (≤) 30 days prior to the signing of informed consent. The 30-day window for each subject will be derived from the date of the last study event in the previous study to the time of signing of informed consent in the current study.
History of drug or alcohol dependence within (≤)24 months prior to Screening.
Drinks more than 21 servings of alcoholic beverages per week or has a positive alcohol result at Screening or Check-in.
Determined by the PI or designee to be inappropriate for this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, 66212

Other trials in United States

About this study

Official title: A Randomized, Crossover Clinical Study to Characterize Nicotine Pharmacokinetics and Subjective Effects of Nicotine Pouches in Adult Cigarette Smokers

Read the detailed description

Potential subjects will complete screening procedures to assess their eligibility within 45 days prior to enrollment, randomization and confinement.

Following the Screening Visit, eligible subjects will be scheduled for a Day 1 Check-in visit to complete procedures to confirm eligibility. Eligible subjects will be enrolled and begin confinement at the clinical site for 10 days and 9 nights. In addition, on Day 1, subjects will use at least one nicotine pouch (7 mg nicotine) but no more than 3 pouches to familiarize themselves with the investigational product (IP). Subjects will participate in separate Test Sessions for plasma nicotine PK assessment, one for each IP. Each Test Session will last for approximately 3 hours following the start of the IP use, and will include collection of plasma samples for PK assessments prior to, during, and following IP use.

Safety will be monitored throughout the study by the Principal Investigator (PI) (or designee) by assessing adverse events (AEs), vital sign measurements, physical examinations (including an oral examination), and clinical laboratory tests. Mandatory physical and oral examination will be performed as part of end of study or early termination procedures.

The clinical site will attempt to contact all subjects who used at least one IP (including subjects who terminate the study early) using their standard procedures approximately 7 days after the last IP use to determine if any AE has occurred since the last study visit. A return visit may be scheduled for follow-up assessments at the discretion of the PI or an appropriately qualified designee.

Conditions: Tobacco Use, Tobacco Smoking
Being tested: Product A, Product B, Product C, Product D, Product E
Medical subject headings: Tobacco Use, Tobacco Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Product AOther
A 4mg nicotine pouch product
Product BOther
A 7mg nicotine pouch product
Product COther
A 7mg nicotine pouch product
Product DOther
A 7mg nicotine pouch product
Product EOther
A 7mg nicotine pouch product
Product FOther
A 7mg nicotine pouch product
Product GOther
A 7mg nicotine pouch product
Product HOther
A 7mg nicotine pouch product
Product IOther
A 7mg nicotine pouch product

Study groups in NCT04846088
Study group	Role	What they receive
Product usage order ABICHDGEF	Experimental	Subjects will use each of the 9 products (ABICHDGEF) during a familiarization period, followed by a 3 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product H; Other: Product I
Product usage order BCADIEHFG	Experimental	Subjects will use each of the 9 products (BCADIEHFG) during a familiarization period, followed by a 3 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product H; Other: Product I
Product usage order CDBEAFIGH	Experimental	Subjects will use each of the 9 products (CDBEAFIGH) during a familiarization period, followed by a 3 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product H; Other: Product I
Product usage order DECFBGAHI	Experimental	Subjects will use each of the 9 products (DECFBGAHI) during a familiarization period, followed by a 3 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product H; Other: Product I
Product usage order EFDGCHBIA	Experimental	Subjects will use each of the 9 products (EFDGCHBIA) during a familiarization period, followed by a 3 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product H; Other: Product I
Product usage order FGEHDICAB	Experimental	Subjects will use each of the 9 products (FGEHDICAB) during a familiarization period, followed by a 3 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product H; Other: Product I
Product usage order GHFIEADBC	Experimental	Subjects will use each of the 9 products (GHFIEADBC) during a familiarization period, followed by a 3 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product H; Other: Product I
Product usage order HIGAFBECD	Experimental	Subjects will use each of the 9 products (HIGAFBECD) during a familiarization period, followed by a 3 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product H; Other: Product I
Product usage order IAHBGCFDE	Experimental	Subjects will use each of the 9 products (IAHBGCFDE) during a familiarization period, followed by a 3 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product H; Other: Product I
Product usage order FEGDHCIBA	Experimental	Subjects will use each of the 9 products (FEGDHCIBA) during a familiarization period, followed by a 3 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product H; Other: Product I
Product usage order GFHEIDACB	Experimental	Subjects will use each of the 9 products (GFHEIDACB) during a familiarization period, followed by a 3 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product H; Other: Product I
Product usage order HGIFAEBDC	Experimental	Subjects will use each of the 9 products (HGIFAEBDC) during a familiarization period, followed by a 3 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product H; Other: Product I
Product usage order IHAGBFCED	Experimental	Subjects will use each of the 9 products (IHAGBFCED) during a familiarization period, followed by a 3 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product H; Other: Product I
Product usage order AIBHCGDFE	Experimental	Subjects will use each of the 9 products (AIBHCGDFE) during a familiarization period, followed by a 3 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product H; Other: Product I
Product usage order BACIDHEGF	Experimental	Subjects will use each of the 9 products (BACIDHEGF) during a familiarization period, followed by a 3 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product H; Other: Product I
Product usage order CBDAEIFHG	Experimental	Subjects will use each of the 9 products (CBDAEIFHG) during a familiarization period, followed by a 3 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product H; Other: Product I
Product usage order DCEBFAGIH	Experimental	Subjects will use each of the 9 products (DCEBFAGIH) during a familiarization period, followed by a 3 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product H; Other: Product I
Product usage order EDFCGBHAI	Experimental	Subjects will use each of the 9 products (EDFCGBHAI) during a familiarization period, followed by a 3 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product H; Other: Product I

What is being measured

The primary outcome is the main question the study is designed to answer.

AUCnic 0-180 mins
Baseline-adjusted area under the plasma nicotine concentration-versus-time curve (AUCnic) from time zero to 180 minutes after the start of IP use
Measured: 0-180 minutes
Cmax
Maximum baseline-adjusted plasma concentration of nicotine
Measured: 180 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Apr 20212 Jun 2021

First posted15 Apr 2021
Study start5 Apr 2021
Primary completion2 Jun 2021
Study completion2 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Tobacco UseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04846088
Sponsor's protocol ID: BAT2221031
Status last verified: Dec 2022
First submitted: 9 Apr 2021
Last updated: 7 Dec 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Crossover Clinical Study to Characterize Nicotine Pharmacokinetics and Subjective Effects of Nicotine Pouches in Adult Cigarette Smokers
ClinicalTrials.gov ID: NCT04846088
Acronym / sponsor ID: BAT2221031
Conditions: Tobacco Use, Tobacco Smoking
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: British American Tobacco (Investments) LimitedIndustry (pharma, biotech, devices)
Study start: 5 Apr 2021 (actual)
Primary completion: 2 Jun 2021 (actual)
Study completion: 2 Jun 2021 (actual)
First posted: 15 Apr 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Potential subjects will complete screening procedures to assess their eligibility within 45 days prior to enrollment, randomization and confinement.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 18

Arm	Type	Receives
Product usage order ABICHDGEF	Experimental	Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product H, Other: Product ISubjects will use each of the 9 products (ABICHDGEF) during a familiarization period, followed by a 3 hour Test Session
Product usage order BCADIEHFG	Experimental	Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product H, Other: Product ISubjects will use each of the 9 products (BCADIEHFG) during a familiarization period, followed by a 3 hour Test Session
Product usage order CDBEAFIGH	Experimental	Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product H, Other: Product ISubjects will use each of the 9 products (CDBEAFIGH) during a familiarization period, followed by a 3 hour Test Session
Product usage order DECFBGAHI	Experimental	Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product H, Other: Product ISubjects will use each of the 9 products (DECFBGAHI) during a familiarization period, followed by a 3 hour Test Session
Product usage order EFDGCHBIA	Experimental	Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product H, Other: Product ISubjects will use each of the 9 products (EFDGCHBIA) during a familiarization period, followed by a 3 hour Test Session
Product usage order FGEHDICAB	Experimental	Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product H, Other: Product ISubjects will use each of the 9 products (FGEHDICAB) during a familiarization period, followed by a 3 hour Test Session
Product usage order GHFIEADBC	Experimental	Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product H, Other: Product ISubjects will use each of the 9 products (GHFIEADBC) during a familiarization period, followed by a 3 hour Test Session
Product usage order HIGAFBECD	Experimental	Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product H, Other: Product ISubjects will use each of the 9 products (HIGAFBECD) during a familiarization period, followed by a 3 hour Test Session
Product usage order IAHBGCFDE	Experimental	Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product H, Other: Product ISubjects will use each of the 9 products (IAHBGCFDE) during a familiarization period, followed by a 3 hour Test Session
Product usage order FEGDHCIBA	Experimental	Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product H, Other: Product ISubjects will use each of the 9 products (FEGDHCIBA) during a familiarization period, followed by a 3 hour Test Session
Product usage order GFHEIDACB	Experimental	Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product H, Other: Product ISubjects will use each of the 9 products (GFHEIDACB) during a familiarization period, followed by a 3 hour Test Session
Product usage order HGIFAEBDC	Experimental	Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product H, Other: Product ISubjects will use each of the 9 products (HGIFAEBDC) during a familiarization period, followed by a 3 hour Test Session
Product usage order IHAGBFCED	Experimental	Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product H, Other: Product ISubjects will use each of the 9 products (IHAGBFCED) during a familiarization period, followed by a 3 hour Test Session
Product usage order AIBHCGDFE	Experimental	Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product H, Other: Product ISubjects will use each of the 9 products (AIBHCGDFE) during a familiarization period, followed by a 3 hour Test Session
Product usage order BACIDHEGF	Experimental	Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product H, Other: Product ISubjects will use each of the 9 products (BACIDHEGF) during a familiarization period, followed by a 3 hour Test Session
Product usage order CBDAEIFHG	Experimental	Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product H, Other: Product ISubjects will use each of the 9 products (CBDAEIFHG) during a familiarization period, followed by a 3 hour Test Session
Product usage order DCEBFAGIH	Experimental	Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product H, Other: Product ISubjects will use each of the 9 products (DCEBFAGIH) during a familiarization period, followed by a 3 hour Test Session
Product usage order EDFCGBHAI	Experimental	Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product H, Other: Product ISubjects will use each of the 9 products (EDFCGBHAI) during a familiarization period, followed by a 3 hour Test Session

Who may qualify

Ages: 22 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (23 listed)

Able to read, understand, and willing to sign an informed consent form (ICF) and complete the questionnaire written in English.
Generally healthy males or females, 22 to 65 years of age, inclusive, at the time of consent.
Body mass index (BMI) within 18.0 to 40.0 kg/m2, inclusive (minimum weight of at least 50.0 kg) at Screening.
Healthy, as determined by no clinically significant medical history, physical examination, 12-lead ECG, vital signs, or laboratory (including hematology, clinical chemistry, urinalysis, and serology) findings at Screening, as judged by the PI or designee.
Smoke combustible, filtered, non-menthol or menthol cigarettes, 83 mm to 100 mm in length as the primary source of tobacco use.

Key exclusion criteria (29 listed)

Inability to tolerate at least one 7 mg nicotine pouch for at least 45 minutes during the Product Familiarization Period at Check-in.
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 or designee, 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 or designee discretion pending approval from the Medical Monitor.
History or presence of bleeding or clotting disorders.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Product AA 4mg nicotine pouch product	Other	Product usage order ABICHDGEF, Product usage order AIBHCGDFE, Product usage order BACIDHEGF, Product usage order BCADIEHFG, Product usage order CBDAEIFHG, Product usage order CDBEAFIGH, Product usage order DCEBFAGIH, Product usage order DECFBGAHI, Product usage order EDFCGBHAI, Product usage order EFDGCHBIA, Product usage order FEGDHCIBA, Product usage order FGEHDICAB, Product usage order GFHEIDACB, Product usage order GHFIEADBC, Product usage order HGIFAEBDC, Product usage order HIGAFBECD, Product usage order IAHBGCFDE, Product usage order IHAGBFCED
Product BA 7mg nicotine pouch product	Other	Product usage order ABICHDGEF, Product usage order AIBHCGDFE, Product usage order BACIDHEGF, Product usage order BCADIEHFG, Product usage order CBDAEIFHG, Product usage order CDBEAFIGH, Product usage order DCEBFAGIH, Product usage order DECFBGAHI, Product usage order EDFCGBHAI, Product usage order EFDGCHBIA, Product usage order FEGDHCIBA, Product usage order FGEHDICAB, Product usage order GFHEIDACB, Product usage order GHFIEADBC, Product usage order HGIFAEBDC, Product usage order HIGAFBECD, Product usage order IAHBGCFDE, Product usage order IHAGBFCED
Product CA 7mg nicotine pouch product	Other	Product usage order ABICHDGEF, Product usage order AIBHCGDFE, Product usage order BACIDHEGF, Product usage order BCADIEHFG, Product usage order CBDAEIFHG, Product usage order CDBEAFIGH, Product usage order DCEBFAGIH, Product usage order DECFBGAHI, Product usage order EDFCGBHAI, Product usage order EFDGCHBIA, Product usage order FEGDHCIBA, Product usage order FGEHDICAB, Product usage order GFHEIDACB, Product usage order GHFIEADBC, Product usage order HGIFAEBDC, Product usage order HIGAFBECD, Product usage order IAHBGCFDE, Product usage order IHAGBFCED
Product DA 7mg nicotine pouch product	Other	Product usage order ABICHDGEF, Product usage order AIBHCGDFE, Product usage order BACIDHEGF, Product usage order BCADIEHFG, Product usage order CBDAEIFHG, Product usage order CDBEAFIGH, Product usage order DCEBFAGIH, Product usage order DECFBGAHI, Product usage order EDFCGBHAI, Product usage order EFDGCHBIA, Product usage order FEGDHCIBA, Product usage order FGEHDICAB, Product usage order GFHEIDACB, Product usage order GHFIEADBC, Product usage order HGIFAEBDC, Product usage order HIGAFBECD, Product usage order IAHBGCFDE, Product usage order IHAGBFCED
Product EA 7mg nicotine pouch product	Other	Product usage order ABICHDGEF, Product usage order AIBHCGDFE, Product usage order BACIDHEGF, Product usage order BCADIEHFG, Product usage order CBDAEIFHG, Product usage order CDBEAFIGH, Product usage order DCEBFAGIH, Product usage order DECFBGAHI, Product usage order EDFCGBHAI, Product usage order EFDGCHBIA, Product usage order FEGDHCIBA, Product usage order FGEHDICAB, Product usage order GFHEIDACB, Product usage order GHFIEADBC, Product usage order HGIFAEBDC, Product usage order HIGAFBECD, Product usage order IAHBGCFDE, Product usage order IHAGBFCED
Product FA 7mg nicotine pouch product	Other	Product usage order ABICHDGEF, Product usage order AIBHCGDFE, Product usage order BACIDHEGF, Product usage order BCADIEHFG, Product usage order CBDAEIFHG, Product usage order CDBEAFIGH, Product usage order DCEBFAGIH, Product usage order DECFBGAHI, Product usage order EDFCGBHAI, Product usage order EFDGCHBIA, Product usage order FEGDHCIBA, Product usage order FGEHDICAB, Product usage order GFHEIDACB, Product usage order GHFIEADBC, Product usage order HGIFAEBDC, Product usage order HIGAFBECD, Product usage order IAHBGCFDE, Product usage order IHAGBFCED
Product GA 7mg nicotine pouch product	Other	Product usage order ABICHDGEF, Product usage order AIBHCGDFE, Product usage order BACIDHEGF, Product usage order BCADIEHFG, Product usage order CBDAEIFHG, Product usage order CDBEAFIGH, Product usage order DCEBFAGIH, Product usage order DECFBGAHI, Product usage order EDFCGBHAI, Product usage order EFDGCHBIA, Product usage order FEGDHCIBA, Product usage order FGEHDICAB, Product usage order GFHEIDACB, Product usage order GHFIEADBC, Product usage order HGIFAEBDC, Product usage order HIGAFBECD, Product usage order IAHBGCFDE, Product usage order IHAGBFCED
Product HA 7mg nicotine pouch product	Other	Product usage order ABICHDGEF, Product usage order AIBHCGDFE, Product usage order BACIDHEGF, Product usage order BCADIEHFG, Product usage order CBDAEIFHG, Product usage order CDBEAFIGH, Product usage order DCEBFAGIH, Product usage order DECFBGAHI, Product usage order EDFCGBHAI, Product usage order EFDGCHBIA, Product usage order FEGDHCIBA, Product usage order FGEHDICAB, Product usage order GFHEIDACB, Product usage order GHFIEADBC, Product usage order HGIFAEBDC, Product usage order HIGAFBECD, Product usage order IAHBGCFDE, Product usage order IHAGBFCED
Product IA 7mg nicotine pouch product	Other	Product usage order ABICHDGEF, Product usage order AIBHCGDFE, Product usage order BACIDHEGF, Product usage order BCADIEHFG, Product usage order CBDAEIFHG, Product usage order CDBEAFIGH, Product usage order DCEBFAGIH, Product usage order DECFBGAHI, Product usage order EDFCGBHAI, Product usage order EFDGCHBIA, Product usage order FEGDHCIBA, Product usage order FGEHDICAB, Product usage order GFHEIDACB, Product usage order GHFIEADBC, Product usage order HGIFAEBDC, Product usage order HIGAFBECD, Product usage order IAHBGCFDE, Product usage order IHAGBFCED

Primary outcome

AUCnic 0-180 mins
Time frame: 0-180 minutes
Baseline-adjusted area under the plasma nicotine concentration-versus-time curve (AUCnic) from time zero to 180 minutes after the start of IP use
Cmax
Time frame: 180 minutes
Maximum baseline-adjusted plasma concentration of nicotine

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Debra Kelsh, MD principal investigator

Altasciences Company Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Product A, Product B and Product C in people with Tobacco Use and Tobacco Smoking, run by British American Tobacco (Investments) Limited at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUCnic 0-180 mins (time frame: 0-180 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04846088.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.