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Completed

NCT Number: NCT03398876

A Study to Assess the Nicotine Pharmacokinetics, Tolerability and Safety With a New Oral Nicotine Replacement Product in Healthy Japanese Smokers

In Part 1, the purpose of this study is to elucidate the single-dose pharmacokinetic profiles of 1 spray and 2 consecutive sprays of oromucosal nicotine spray (ONS) in comparison with those of nicotine gum and cigarette smoking in healthy Japanese smokers. In Part 2, the purpose is to evaluate the multiple-dose nicotine pharmacokinetics of ONS administered repeated-dose administration in healthy Japanese smokers.

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Key information

Conditions

Healthy

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Souseikai Hakata Clinic

Fukuoka, 8120025, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male or female Japanese participants between the ages of 20 and 50 years, inclusive. Health is defined as the absence of clinically relevant abnormalities identified by a detailed medical history, blood pressure, pulse rate measurements, 12-lead electrocardiogram (ECG) as well as clinical laboratory tests, as judged by the principal investigator or sub investigator.
  • Smoking of at least 15 cigarettes daily during at least one year preceding inclusion
  • Body Mass Index between 17.5 and 30.0 kilogram per square meter (kg/m^2) and a total body weight greater than or equal to (>=) 50.0 kg
  • Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study
  • All women of childbearing potential, except for postmenopausal females, must have a negative urine beta-human chorionic gonadotropin (beta-hCG) at screening of Part 1 and all planned visits of Part 1 and Part 2

Exclusion criteria

  • Evidence or history of an acute or chronic medical or psychiatric condition or allergy or laboratory abnormality, or of use of drugs that, in the judgment of the principal investigator or sub investigator, increase the risk associated with study participation or interfere with the interpretability of study results
  • Females: Pregnancy, breast-feeding, premenopausal, or perimenopausal state with insufficient contraception
  • Treatment with an investigational drug within 3 months preceding the first dose of study product
  • Participant has donated blood or blood product or had substantial loss of blood more than 200 milliliter (mL) within 1 month before study products administration, or greater than or equal to (>=) 400 mL within 3 months for males and 4 months for females before study products administration, or participant has donated a total volume of blood in the past one year exceeding 1,200 mL for males and 800 mL for females, or participant has an intention to donate blood or blood products during the study and for at least 3 months for males and 4 months for females for blood, or at least 2 months for both genders for blood products after completion of the study
  • Exclusion Criterion for Only Part 2: participants who is analyzed as cytochrome (CYP)2A6 *4/*4 by CYP2A6 genetic polymorphism test at Visit 1 of Part 1

Treatment and study plan

Oromucosal Nicotine Spray (ONS)

Drug

Participants will receive oral dose of oromucosal nicotine spray (ONS).

Nicotine gum

Drug

Participants will chew nicotine gum for 30 minutes.

Cigarette

Other

Participants will smoke one cigarette as 10 puffs for 3 minutes.

Primary outcomes

  1. Part 1: Maximum Baseline Corrected Plasma Nicotine Concentration (cCmax)

    Time frame: Predose; 2, 4, 6, 8, 10, 15, 20, 30, 45 and 60 minute (min) and 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose

    cCmax is defined as the maximum baseline corrected plasma nicotine concentration (cCmax).

  2. Part 1: Baseline Corrected Area Under the Plasma Nicotine Concentration versus (vs) Time Curve Until the Last Measurable Time Point (cAUCt)

    Time frame: Predose; 2, 4, 6, 8, 10, 15, 20, 30, 45 and 60 min and 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose

    cAUCt is defined as the baseline corrected area under the plasma nicotine concentration-vs time curve until the last measurable time point.

  3. Part 1: Baseline Corrected Area Under the Plasma Nicotine Concentration-vs Time Curve Extrapolated to Infinite (cAUC[infinity])

    Time frame: Predose; 2, 4, 6, 8, 10, 15, 20, 30, 45 and 60 min and 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose

    cAUC(infinity) is defined as the baseline corrected area under the plasma nicotine concentration-vs time curve extrapolated to infinite.

  4. Part 1: Baseline Corrected Area Under the Plasma Nicotine Concentration-vs Time Curve until the Last Measurable Time Point (cAUCt)

    Time frame: Predose; 2, 4, 6, 8, 10, 15, 20, 30, 45 and 60 min and 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose

    cAUCt is defined as baseline corrected area under the plasma nicotine concentration-vs time curve until the last measurable time point.

  5. Part 2: Average Plasma Nicotine Concentration During the Last Dosing Interval/Intervals (Cav)

    Time frame: Predose, 2, 4, 6, 8, 10, 15, 20, 30 post last dose (last dose: Hour 11.5 for Treatment E and Hour 11 for Treatment F); 45 and 60 min post last dose for Treatment F

    Cav is defined as the average plasma nicotine concentration during the last dosing interval/intervals.

  6. Part 2: Area Under the Plasma Nicotine Concentration-vs Time Curve During the Last Dosing Interval/Intervals (AUCtau)

    Time frame: Predose, 2, 4, 6, 8, 10, 15, 20, 30 post last dose (last dose: Hour 11.5 for Treatment E and Hour 11 for Treatment F); 45 and 60 min post last dose for Treatment F

    AUCtau is defined as the area under the plasma nicotine concentration-vs time curve during the last dosing interval/intervals.

  7. Part 2: Maximum Plasma Nicotine Concentration During the Last Dosing Interval/Intervals (Cmax)

    Time frame: Predose, 2, 4, 6, 8, 10, 15, 20, 30 post last dose (last dose: Hour 11.5 for Treatment E and Hour 11 for Treatment F); 45 and 60 min post last dose for Treatment F

    Cmax is defined as maximum observed plasma nicotine concentration.

Secondary outcomes

  1. Part 1: Area Under the Plasma Nicotine Concentration-vs Time Curve until 10 Minutes after Start of Administration [AUC10min],

    Time frame: Predose; 2, 4, 6, 8, 10 min postdose

    AUC10min is defined as the area under the plasma nicotine concentration-vs time curve until 10 minutes after start of administration.

  2. Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: Predose; 2, 4, 6, 8, 10, 15, 20, 30, 45 and 60 min and 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose

    Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

  3. Part 1: Terminal Half-Life [t1/2]

    Time frame: Predose; 2, 4, 6, 8, 10, 15, 20, 30, 45 and 60 min and 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose

    Terminal half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).

  4. Part 1: Terminal Elimination Rate Constant (Lambda[z])

    Time frame: Predose; 2, 4, 6, 8, 10, 15, 20, 30, 45 and 60 min and 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose

    Lambda (z) is apparent terminal elimination rate constant, determined by linear regression using the terminal log-linear phase of the log transformed concentration-time curve.

  5. Part 2: Minimum Plasma Nicotine Concentration During the Last Dosing Interval/Intervals (Cmin)

    Time frame: Predose, 2, 4, 6, 8, 10, 15, 20, 30 post last dose (last dose: Hour 11.5 for Treatment E and Hour 11 for Treatment F); 45 and 60 min post last dose for Treatment F

    Cmin is defined as the minimum plasma nicotine concentration during the last dosing interval/intervals.

  6. Part 2: Peak-Trough Fluctuation [PTF]

    Time frame: Predose, 2, 4, 6, 8, 10, 15, 20, 30 post last dose (last dose: Hour 11.5 for Treatment E and Hour 11 for Treatment F); 45 and 60 min post last dose for Treatment F

    PTF calculated by 100*(Cmax - Cmin)/Cav will be assessed.

  7. Part 2: Swing

    Time frame: Predose, 2, 4, 6, 8, 10, 15, 20, 30 post last dose (last dose: Hour 11.5 for Treatment E and Hour 11 for Treatment F); 45 and 60 min post last dose for Treatment F

    Swing will be calculated as (Cmax - Cmin)/Cmin.

  8. Part 2: Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: Predose, 2, 4, 6, 8, 10, 15, 20, 30 post last dose (last dose: Hour 11.5 for Treatment E and Hour 11 for Treatment F); 45 and 60 min post last dose for Treatment F

    Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

  9. Part 1 and Part 2: Number of Participants with Adverse Events (AEs)

    Time frame: Up to 4 months

    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Sponsors and collaborators

Lead sponsor

Janssen Pharmaceutical K.K.

Industry

Registry information

Official study title

A Single-dose and Repeated-dose, Open-label, Randomized, Cross-over Study to Assess the Nicotine Pharmacokinetics, Tolerability and Safety With A New Oral Nicotine Replacement Product in Healthy Japanese Smokers.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 16, 2018
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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