NCT03369340

Brief Summary

This is a single-center, open-label, randomized, crossover study to evaluate the pharmacokinetic (PK) profiles of four P3P variants (differing in nicotine aerosol particle size, nicotine concentration and in the absence or presence of a flavoring system), following a fixed puffing regimen and an ad libitum use period. In addition, pharmacodynamic (PD) effects (subjective effects and related behavioral assessments), as well as human puffing topography, will be evaluated, to provide further insights on product safety, acceptance, and use.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2017

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2018

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

January 31, 2020

Completed
Last Updated

January 31, 2020

Status Verified

January 1, 2020

Enrollment Period

3 months

First QC Date

November 22, 2017

Results QC Date

May 6, 2019

Last Update Submit

January 21, 2020

Conditions

Pharmacokinetics

Keywords

NicotineNicotine-containing product

Outcome Measures

Primary Outcomes (4)

  • Plasma Nicotine Concentration-time Profile

    To measure the plasma nicotine concentration-time profile of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels.

    Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4

  • Maximum Plasma Concentration [Cmax]

    To measure the maximum nicotine plasma concentration \[Cmax\] of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels.

    Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4

  • Time to the Maximum Nicotine Concentration [Tmax]

    To measure the time to maximum nicotine concentration \[Tmax\] of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels.

    Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4

  • Area Under the Concentration-time Curve From Start of Product Use (T0 Fix) to 4 Hours [AUCfix (0-4h)]

    To measure the area under the plasma concentration-time curve of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels.

    Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4

Secondary Outcomes (14)

  • Plasma Nicotine Concentration-time Profile

    Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4

  • Peak Plasma Nicotine Concentration [Cpeak]

    Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4

  • Time to Peak Plasma Nicotine Concentration [Tpeak]

    Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4

  • Trough Plasma Nicotine Concentration [Ctrough]

    Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4

  • Average of Plasma Nicotine Concentration From T0 ad Lib to 1 Hour [Caverage]

    Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour during ad libitum use) on Days 1, 2, 3 and 4

  • +9 more secondary outcomes

Study Arms (6)

Product Sequence 1

ACTIVE COMPARATOR

Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of: P3P 2 on Day 2; P3P 4 on Day 3; P3P 1 on Day 4

Other: P3P 1Other: P3P 2Other: P3P 3Other: P3P 4

Product Sequence 2

ACTIVE COMPARATOR

Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of: P3P 4 on Day 2; P3P 1 on Day 3; P3P 2 on Day 4

Other: P3P 1Other: P3P 2Other: P3P 3Other: P3P 4

Product Sequence 3

ACTIVE COMPARATOR

Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of: P3P 1 on Day 2; P3P 2 on Day 3; P3P 4 on Day 4

Other: P3P 1Other: P3P 2Other: P3P 3Other: P3P 4

Product Sequence 4

ACTIVE COMPARATOR

Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of: P3P 1 on Day 2; P3P 4 on Day 3; P3P 2 on Day 4

Other: P3P 1Other: P3P 2Other: P3P 3Other: P3P 4

Product Sequence 5

ACTIVE COMPARATOR

Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of: P3P 2 on Day 2; P3P 1 on Day 3; P3P 4 on Day 4

Other: P3P 1Other: P3P 2Other: P3P 3Other: P3P 4

Product Sequence 6

ACTIVE COMPARATOR

Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of: P3P 4 on Day 2; P3P 2 on Day 3; P3P 1 on Day 4

Other: P3P 1Other: P3P 2Other: P3P 3Other: P3P 4

Interventions

P3P 1OTHER

2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm

Product Sequence 1Product Sequence 2Product Sequence 3Product Sequence 4Product Sequence 5Product Sequence 6
P3P 2OTHER

2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm

Product Sequence 1Product Sequence 2Product Sequence 3Product Sequence 4Product Sequence 5Product Sequence 6
P3P 3OTHER

1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm

Product Sequence 1Product Sequence 2Product Sequence 3Product Sequence 4Product Sequence 5Product Sequence 6
P3P 4OTHER

2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm

Product Sequence 1Product Sequence 2Product Sequence 3Product Sequence 4Product Sequence 5Product Sequence 6

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has signed the Informed Consent Form (ICF) and is able to understand the information provided in the ICF.
  • Subject is between 21 and 65 years old.
  • Subject is Caucasian.
  • Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the screening period.
  • Subject has been smoking at least 10 commercially available cigarettes per day at least for the last 4 weeks prior to Screening Visit. Smoking status will be verified based on a urinary cotinine test (cotinine ≥ 200 ng/mL).
  • Subject has been smoking for at least the last 3 years prior to Screening Visit.
  • Subject does not plan to quit smoking in the next 2 months after the Screening Visit.

You may not qualify if:

  • Female subject is pregnant or breastfeeding.
  • Female subject uses estrogen-containing hormonal contraception or hormone replacement therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CROSS Research

Arzo, Canton Ticino, 6864, Switzerland

Location

Results Point of Contact

Title
Christelle Haziza, Director Health Science and Biostatistics
Organization
Philip Morris Products S.A.
ClinicalTrials.PMI@pmi.com
+41 58 242 11 11

Study Officials

  • Christelle Haziza, PhD

    Philip Morris Products S.A.

    STUDY CHAIR

  • Milko Radicioni, MD

    CROSS Research, Arzo, Ticino, Switzerland

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Sponsor staff, Investigator, the subjects and the investigational site will be blinded to the randomization sequences until they are assigned. Subjects will not be informed of the complete sequence to which they have been assigned.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: A single-center, open-label, randomized, crossover study.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2017

First Posted

December 12, 2017

Study Start

November 7, 2017

Primary Completion

February 1, 2018

Study Completion

May 2, 2018

Last Updated

January 31, 2020

Results First Posted

January 31, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)