Trials Sponsors Conditions Drugs Pricing

Conditions

Tobacco Use

Keywords

NicotineNicotine-containing productsTobaccoPharmacokinetics

Outcome Measures

Primary Outcomes (6)

Maximum Plasma Concentration [Cmax]
To measure Cmax following use of the investigational products and reference products
Measured from start of product use to 24 hours
Area under the observed concentration-time curve (AUC) from start of product use (T0) to timepoint of last quantifiable concentration [AUC0-last] and extrapolated to infinity [AUC0-infinity]
To measure the area under the background-corrected concentration-time curve (AUC) from start of product use
Measured from start of product use (T0) to 2 minutes, to 4 minutes, to 10 hours, to time of last quantifiable concentration.
Ratio of [AUC0-last] and [AUC0-infinity]
To measure the ratio of \[AUC0-last\] and \[AUC0-infinity\]
Measured from start of product use to 24 hours
Time to the observed maximum concentration [Tmax]
To measure the maximum ratio of background-corrected concentration over time, from T0 (excluded) to Tmax (included)
Measured from start of product use to 24 hours
Elimination rate constant [kel]
To measure the fraction of nicotine eliminated per unit of time, following use of the investigational products and reference products

Study Arms (4)

Product Sequence 1

ACTIVE COMPARATOR

From Day 1 to Day 4, after at least 23 hours of abstinence from any nicotine/tobacco containing products, subjects will use one of the four investigational products according to randomized product use sequence and as instructed by the investigational site personnel. The list of possible sequences are: NP2-4mg; NP2-6mg; Loz-4mg; Gum-4mg / NP2-6mg; Gum-4mg; NP2-4mg; Loz-4mg / Gum-4mg; Loz-4mg; NP2-6mg; NP2-4mg / Loz-4mg; NP2-4mg; Gum-4mg; NP2-6mg

Other: NP2-4mgOther: NP2-6 mgOther: Loz-4mgOther: Gum-4mg

Product Sequence 2

ACTIVE COMPARATOR

Interventions

NP2-4mgOther

NP2-4 mg is a new product containing tobacco-derived nicotine.

Product Sequence 1Product Sequence 2Product Sequence 3Product Sequence 4

NP2-6 mgOther

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Subject has signed the ICF and is able to understand the information provided in the ICF.
Subject has smoked on a daily basis for at least the last 18 months prior to the Screening visit.

Sponsors & Collaborators

Philip Morris Products S.A.
Industrylead

Study Sites (2)

Pharma Medica Research Inc.

Toronto, Ontario, M1S 3V6, Canada

Syneos Health Clinique Inc.

Québec, G1P 0A2, Canada

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

Christelle Haziza, PhD
Philip Morris Products S.A.
STUDY CHAIR

Enrollment

56 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Masking Details: This is a partially blinded study. The Investigator and subjects will be blinded to the randomized sequence and to the variants of the investigational product (IP). In contrast, the pharmacy staff will not be blinded to the randomized sequence and to the variants of the IP.
Purpose: BASIC SCIENCE
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 6, 2023

First Posted

December 14, 2023

You may not qualify if:

Subject has reasons other than medical (e.g., psychological, social reason) not to be part of the study, as determined by the Investigator.
Subject is legally incompetent, or physically or mentally incapable of giving consent (e.g., emergency situation, under guardianship, prisoners).
Subject has a clinically relevant disease which requires medication or any other medical condition including abnormal spirometry, safety laboratory, as determined by the Investigator.
Subject presents difficulty with venipuncture and/or poor venous access.
Subject has an oromucosal or dental condition, which may affect the use of the investigational products, as determined by the Investigator or subject has orthodontic braces and retention wire (could likely interfere with the gum dosing).
Subject has medical conditions which require, or will require during the study, a medical intervention (e.g., start of treatment, surgery, hospitalization).
Presence of fever (body temperature \>37.5°C) (e.g., a fever associated with a symptomatic viral or bacterial infection) within 2 weeks prior to dosing.
Subject has a Hemoglobin level \< 11.0 g/dL for females and \< 12.0 g/dL for males at the Screening.
Subject uses medication or any substance that aids in smoking cessation.
Subject postponed the decision to quit using tobaccoor nicotine-containing products in order to participate in this study.
Subject previously attempted to quit using tobacco- or nicotine-containing products within 28 days prior to the first study product administration.
Subject has donated plasma within seven days prior to Screening or has donated or lost 450 mL or more of whole blood within 8 weeks prior to Screening for males, and in the 12 weeks prior to Screening for females.
Subject has a known sensitivity or allergy to any of the investigational products, or ingredients.
Subject has a positive serology test for HIV 1/2, Hepatitis B, Hepatitis C.
Subject has a history of alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to screening that exceeds 10 units for women or 15 units for men of alcohol per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).
+8 more criteria

Pharmacokinetics and Comparative Bioavailability of Nicotine From Two Variants of NP2, NP2-4mg and NP2-6mg, Compared to Nicotine Lozenge 4mg (Loz-4mg) and Nicotine Gum 4mg (Gum-4mg)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Study Arms (4)

Product Sequence 1

Product Sequence 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Product Sequence 3

Product Sequence 4

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Study Arms (4)

Product Sequence 1

Product Sequence 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Product Sequence 3

Product Sequence 4

You may not qualify if:

Source record

Locations