CSD190102: A Study to Assess Nicotine Pharmacokinetic Parameters After Use of Two Smokeless Tobacco Products

NCT03993782 | Completed

• 1 other identifier: CSD190102
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to compare plasma nicotine uptake in adult snus consumers after using investigational snus products (A19010-R and B19010-O).

Conditions

Tobacco Use

Outcome Measures

Primary Outcomes (1)

• AUCnic 0-240

  Area under the baseline-adjusted nicotine concentration-versus-time curve from time zero to 240 minutes after the start of a 30-minute single IP use period.

  240 minutes

Study Arms (2)

A19010-R, B19010-O Use Group

EXPERIMENTAL

Use of product A19010-R exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations, followed by use of product B19010-O exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations.

Other: A19010-R; Other: B19010-O

B19010-O, A19010-R Use Group

EXPERIMENTAL

Use of product B19010-O exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations, followed by use of product A19010-R exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations.

Other: A19010-R; Other: B19010-O

Interventions

A19010-R OTHER

A snus product

A19010-R, B19010-O Use Group; B19010-O, A19010-R Use Group

B19010-O OTHER

A snus product

A19010-R, B19010-O Use Group; B19010-O, A19010-R Use Group

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 willing to sign an informed consent form (ICF) and complete questionnaires;
• Generally healthy male or female, 21 to 60 years of age, inclusive, at the time of signing the ICF;
• Positive urine cotinine test at the Screening Visit and Day 1;
• Childbearing females must be willing to use a form of contraception acceptable to the Principal Investigator (PI) from the time of signing the ICF until study discharge; acceptable methods include:
• a. Female subjects who are heterosexually active and of childbearing potential (e.g., neither surgically sterile postmenopausal) must have been using one of the following forms of contraception for the time period indicated and agree to continue using it through completion of the study:
• Hormonal (e.g., oral, vaginal ring, transdermal patch, implant, injection) consistently for at least 3 months prior to Check-in
• Double barrier (i.e., condom with spermicide or diaphragm with spermicide) consistently for at least 4 weeks prior to Check-in
• Intrauterine device for at least 4 months prior to Check-in
• Exclusive partner who has been vasectomized for at least 6 months (inclusive) prior to Check-in
• Female subjects of childbearing potential who are not currently engaging
• In heterosexual intercourse must agree to use one of the above methods of birth control through completion of study, in the event that they have heterosexual intercourse during the course of the study.
• Female subjects who are of non-childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to Check in:
• Hysteroscopic sterilization (including Essure® or similar nonsurgical sterilization procedures);
• Bilateral tubal ligation or bilateral salpingectomy
• Hysterectomy

You may not qualify if:

• Presence of clinically significant uncontrolled cardiovascular, chronic 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 study subject unsuitable to participate in this clinical study;
• History, presence of, or clinical laboratory test results indicating diabetes;
• Hemoglobin level \< 11.0 g/dL for females and \< 12.0 g/dL for males at the Screening Visit;
• History or presence of bleeding or clotting disorders;
• Daily use of aspirin (\> 325mg/day) or anticoagulants;
• Whole blood donation within 8 weeks (≤ 56 days) prior to the signing the ICF;
• Plasma donation within (≤) 7 days of signing the ICF;
• Systolic blood pressure of \> 160 mmHg or a diastolic blood pressure of \> 95 mmHg, measured after being seated for 5 minutes;
• Weight of ≤ 110 pounds;
• Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV);
• Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that have been surgically and/or cryogenically removed;
• 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 the ICF;
• Participation in another clinical trial within (≤) 30 days of 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 the ICF in the current study);
• Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the study;
• A positive urine drug screen without evidence of prescribed corresponding acceptable concomitant medication(s) at the Screening Visit or at check-in on Day 1;

Sponsors & Collaborators

• RAI Services Company: lead
• Celerion: collaborator

Study Sites (6)

Woodland Research Northwest, LLC

Rogers, Arkansas, 72758, United States

Location

Central Kentucky Research

Lexington, Kentucky, 40509, 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

New Orleans Center for Clinical Research (NOCCR)

Knoxville, Tennessee, 37920, United States

Location

Spaulding Clinical Research, LLC

West Bend, Wisconsin, 53095, United States

Location

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jason Hong, MD

  RAIS

  STUDY DIRECTOR

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: June 19, 2019
• First Posted: June 21, 2019
• Study Start: July 8, 2019
• Primary Completion: September 13, 2019
• Study Completion: September 13, 2019
• Last Updated: October 25, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)