BAT3221032: A Study to Evaluate the Effects of Switching From Cigarette Smoking to Using One of Five Variants of a Heated Tobacco Product on Biomarkers of Exposure and Biomarkers of Potential Harm in Healthy Subjects

NCT05142436 | Completed

• 1 other identifier: BAT3221032
• Study Type: interventional
• Target: 806
• Locations: 1 country
• Sites: 18

Brief Summary

This is a randomized, controlled, multi-center, open-label, 8-cohort parallel group study to assess changes in select biomarkers of exposure (BoE) and biomarkers of potential harm (BoPH) in generally healthy smokers switching to the study investigational products (IPs), compared to subjects who continue to smoke, undergo smoking abstinence, or have never smoked.

Conditions

Smoking; Tobacco Use; Tobacco Smoking

Outcome Measures

Primary Outcomes (5)

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

  To quantitively assess differences in biomarker of exposure, Total NNAL, at 90 days between subjects who continue to smoke combustible cigarettes (CC) and subjects who switch to an HTP

  90 days

• Monohydroxybutyl mercapturic acid (MHBMA)

  To quantitively assess differences in biomarker of exposure, MHBMA, at 90 days between subjects who continue to smoke CC and subjects who switch to an HTP

  90 days

• 3-hydroxypropyl mercapturic acid (3-HPMA)

  To quantitively assess differences in biomarker of exposure, 3-HPMA, at 90 days between subjects who continue to smoke CC and subjects who switch to an HTP

  90 days

• S-phenyl mercapturic acid (S-PMA)

  To quantitively assess differences in biomarker of exposure, S-PMA, at 90 days between subjects who continue to smoke CC and subjects who switch to an HTP

  90 days

• Carboxyhemoglobin (COHb)

  To quantitively assess differences in biomarker of exposure, COHb, at 90 days between subjects who continue to smoke CC and subjects who switch to an HTP

  90 days

Study Arms (8)

Cohort 1: Non-combusted cigarette variant 42001402 and product use mode B

EXPERIMENTAL

Subjects randomized to use of a non-combusted cigarette variant and product use mode B

Other: Product A: Non-Combusted Cigarette Variant 42001402 and product use Mode B

Cohort 2: Non-combusted cigarette variant 42001399 and product use mode B

EXPERIMENTAL

Subjects randomized to use of a non-combusted cigarette variant and product use mode B

Other: Product B: Non-Combusted Cigarette Variant 42001399 and product use Mode B

Cohort 3: Non-combusted cigarette variant 42001401 and product use mode B

EXPERIMENTAL

Subjects randomized to use of a non-combusted cigarette variant and product use mode B

Other: Product C: Non-Combusted Cigarette Variant 42001401 and product use Mode B

Cohort 4: Non-combusted cigarette variant 40007386 and product use mode B

EXPERIMENTAL

Subjects randomized to use of a non-combusted cigarette variant and product use mode B

Other: Product D: Non-Combusted Cigarette Variant 40007386 and product use Mode B

Cohort 5: Non-combusted cigarette variant 42001402 and product use mode A

EXPERIMENTAL

Subjects randomized to use of a non-combusted cigarette variant and product use mode A

Other: Product E: Non-Combusted Cigarette Variant 42001402 and product use Mode A

Cohort 6: Usual Brand Cigarettes

NO INTERVENTION

Subjects randomized to continue to smoke usual brand cigarettes

Cohort 7: Assisted Smoking Cessation

NO INTERVENTION

Subjects assigned to assisted smoking cessation

Cohort 8: Never-Smokers

NO INTERVENTION

Never-smokers

Interventions

Product A: Non-Combusted Cigarette Variant 42001402 and product use Mode B OTHER

42001402, A Heated Tobacco Product using a Non-Combusted Cigarette Variant and product use Mode B

Cohort 1: Non-combusted cigarette variant 42001402 and product use mode B

Product B: Non-Combusted Cigarette Variant 42001399 and product use Mode B OTHER

42001399, A Heated Tobacco Product using a Non-Combusted Cigarette Variant and product use Mode B

Cohort 2: Non-combusted cigarette variant 42001399 and product use mode B

Product C: Non-Combusted Cigarette Variant 42001401 and product use Mode B OTHER

42001401, A Heated Tobacco Product using a Non-Combusted Cigarette Variant and product use Mode B

Cohort 3: Non-combusted cigarette variant 42001401 and product use mode B

Product D: Non-Combusted Cigarette Variant 40007386 and product use Mode B OTHER

40007386, A Heated Tobacco Product using a Non-Combusted Cigarette Variant and product use Mode B

Cohort 4: Non-combusted cigarette variant 40007386 and product use mode B

Product E: Non-Combusted Cigarette Variant 42001402 and product use Mode A OTHER

42001402, A Heated Tobacco Product using a Non-Combusted Cigarette Variant and product use Mode A

Cohort 5: Non-combusted cigarette variant 42001402 and product use mode A

Eligibility Criteria

• Age: 26 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All Subjects
• Able to read, understand, and willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English or Spanish.
• Generally healthy male or female, 26 to 55 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 110 lbs. \[50 kg\]) at Screening.
• Agree to abide by the study restrictions and requirements, including use of the assigned product or to undergo smoking cessation, and agree to in-clinic, overnight confinement at Visits 1 and 4.
• Willing to refrain from consuming alcohol within 24 hours prior to Screening and check-in at Visits 1 and 4.
• Willing to refrain from consuming cruciferous vegetables and grilled, smoked, fried or barbequed food, and to avoid being in the presence of the cooking of these foods, and to refrain from consuming cured sandwich meats, bacon, salami, and sausages, for 48 hours prior to check-in at Visits 1 and 4.
• Males must be vasectomized, abstinent from heterosexual intercourse (as a lifestyle choice, not just for the purpose of study participation), or they (or their female partner of childbearing potential) must use acceptable methods of birth control from Visit 1 until the end of the study.
• Females must be willing to use a form of contraception acceptable to the PI from the time of signing informed consent until the end of the study.
• 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;
• Physical barrier method (e.g., condom, diaphragm/sponge/cervical cap) with spermicide;
• Non-hormone releasing intrauterine devices (IUD) or hormone-releasing IUDs (e.g., Mirena or Kyleena);
• Vasectomized partner;

You may not qualify if:

• All Subjects
• Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease(s), 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 (history of gestational diabetes which is no longer present nor indicated by clinical laboratory test results is acceptable).
• 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.
• Subjects who have had an acute illness (e.g., upper respiratory tract infection) requiring treatment within 4 weeks prior to Visit 1 (subjects who had viral infections that resolved ≥ 2 weeks prior to Visit 1 will be admissible).
• Subjects who have received any medications or substances (other than nicotine) which:
• interfere with the cyclooxygenase pathway (e.g., anti-inflammatory drugs including aspirin and ibuprofen) within 14 days prior to Visit 1
• are known to be strong inducers or inhibitors of cytochrome P450 (CYP) enzymes within 14 days or 5 half-lives of the drug (whichever is longer) prior to Visit 1
• 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.
• 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).
• Individuals ≥ 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy.
• Participation in another clinical trial within (≤) 30 days prior to signing the ICF. 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 informed consent in the current study.

Sponsors & Collaborators

• British American Tobacco (Investments) Limited: lead
• Celerion: collaborator

Study Sites (18)

Pillar Clinical Research, LLC

Bentonville, Arkansas, 72712, United States

Location

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

Woodland Research Northwest

Rogers, Arkansas, 72758, United States

Location

Bright Research Center

Miami, Florida, 33144, United States

Location

Infinite Clinical Trials

Morrow, Georgia, 30260, United States

Location

AMR Lexington

Lexington, Kentucky, 40509, United States

Location

AMR Kansas City

Kansas City, Missouri, 64114, United States

Location

QPS Bio-Kinetic

Springfield, Missouri, 65802, United States

Location

High Point Clinical Trials Center

High Point, North Carolina, 27265, United States

Location

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

Location

M3 Wake Research, Inc.

Raleigh, North Carolina, 27612, United States

Location

Centricity Research

Columbus, Ohio, 43213, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

AMR Knoxville

Knoxville, Tennessee, 37920, United States

Location

InSite Clinical Research, LLC.

DeSoto, Texas, 75115, United States

Location

Pillar Clinical Research

Richardson, Texas, 75080, United States

Location

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Smoking; Tobacco Use; Tobacco Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Nathan Gale

  BAT

  STUDY DIRECTOR

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: November 16, 2021
• First Posted: December 2, 2021
• Study Start: January 13, 2022
• Primary Completion: December 13, 2022
• Study Completion: December 13, 2022
• Last Updated: December 16, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)