A Study to Characterize Nicotine Pharmacokinetics and Subjective Effects of Nicotine Pouches in Adult Cigarette Smokers
A Randomized, Crossover Clinical Study to Characterize Nicotine Pharmacokinetics and Subjective Effects of Nicotine Pouches in Adult Cigarette Smokers
1 other identifier
interventional
42
1 country
1
Brief 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) \[e.g., snus, moist snuff\].
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 Apr 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
Study Start
First participant enrolled
April 5, 2021
CompletedFirst Submitted
Initial submission to the registry
April 9, 2021
CompletedFirst Posted
Study publicly available on registry
April 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2021
CompletedDecember 7, 2022
December 1, 2022
2 months
April 9, 2021
December 6, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
0-180 minutes
Cmax
Maximum baseline-adjusted plasma concentration of nicotine
180 minutes
Study Arms (18)
Product usage order ABICHDGEF
EXPERIMENTALSubjects will use each of the 9 products (ABICHDGEF) during a familiarization period, followed by a 3 hour Test Session
Product usage order BCADIEHFG
EXPERIMENTALSubjects will use each of the 9 products (BCADIEHFG) during a familiarization period, followed by a 3 hour Test Session
Product usage order CDBEAFIGH
EXPERIMENTALSubjects will use each of the 9 products (CDBEAFIGH) during a familiarization period, followed by a 3 hour Test Session
Product usage order DECFBGAHI
EXPERIMENTALSubjects will use each of the 9 products (DECFBGAHI) during a familiarization period, followed by a 3 hour Test Session
Product usage order EFDGCHBIA
EXPERIMENTALSubjects will use each of the 9 products (EFDGCHBIA) during a familiarization period, followed by a 3 hour Test Session
Product usage order FGEHDICAB
EXPERIMENTALSubjects will use each of the 9 products (FGEHDICAB) during a familiarization period, followed by a 3 hour Test Session
Product usage order GHFIEADBC
EXPERIMENTALSubjects will use each of the 9 products (GHFIEADBC) during a familiarization period, followed by a 3 hour Test Session
Product usage order HIGAFBECD
EXPERIMENTALSubjects will use each of the 9 products (HIGAFBECD) during a familiarization period, followed by a 3 hour Test Session
Product usage order IAHBGCFDE
EXPERIMENTALSubjects will use each of the 9 products (IAHBGCFDE) during a familiarization period, followed by a 3 hour Test Session
Product usage order FEGDHCIBA
EXPERIMENTALSubjects will use each of the 9 products (FEGDHCIBA) during a familiarization period, followed by a 3 hour Test Session
Product usage order GFHEIDACB
EXPERIMENTALSubjects will use each of the 9 products (GFHEIDACB) during a familiarization period, followed by a 3 hour Test Session
Product usage order HGIFAEBDC
EXPERIMENTALSubjects will use each of the 9 products (HGIFAEBDC) during a familiarization period, followed by a 3 hour Test Session
Product usage order IHAGBFCED
EXPERIMENTALSubjects will use each of the 9 products (IHAGBFCED) during a familiarization period, followed by a 3 hour Test Session
Product usage order AIBHCGDFE
EXPERIMENTALSubjects will use each of the 9 products (AIBHCGDFE) during a familiarization period, followed by a 3 hour Test Session
Product usage order BACIDHEGF
EXPERIMENTALSubjects will use each of the 9 products (BACIDHEGF) during a familiarization period, followed by a 3 hour Test Session
Product usage order CBDAEIFHG
EXPERIMENTALSubjects will use each of the 9 products (CBDAEIFHG) during a familiarization period, followed by a 3 hour Test Session
Product usage order DCEBFAGIH
EXPERIMENTALSubjects will use each of the 9 products (DCEBFAGIH) during a familiarization period, followed by a 3 hour Test Session
Product usage order EDFCGBHAI
EXPERIMENTALSubjects will use each of the 9 products (EDFCGBHAI) during a familiarization period, followed by a 3 hour Test Session
Interventions
A 4mg nicotine pouch product
A 7mg nicotine pouch product
A 7mg nicotine pouch product
A 7mg nicotine pouch product
A 7mg nicotine pouch product
A 7mg nicotine pouch product
A 7mg nicotine pouch product
A 7mg nicotine pouch product
A 7mg nicotine pouch product
Eligibility Criteria
You may qualify if:
- 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.
- 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).
- +8 more criteria
You may not qualify if:
- 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.
- 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.
- +14 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
April 9, 2021
First Posted
April 15, 2021
Study Start
April 5, 2021
Primary Completion
June 2, 2021
Study Completion
June 2, 2021
Last Updated
December 7, 2022
Record last verified: 2022-12