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Study to Investigate the Nicotine Pharmacokinetic Profiles and Pharmacodynamic Effects of P4M3 Variants

NCT03379740 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-11-22

Study results available
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Summary

This is a single-center, open-label, concentration-ranging study to evaluate the nicotine PK profile and PD effects in healthy adult experienced users of closed tank/cartridge e-cigarettes using four different variants of P4M3 (nicotine concentration of 1.7%, 1.7% with 1.1% lactic acid \[LA\], 3% with 1.1% LA, and 4% with 2% LA) or their own e-cigarettes.

Conditions

  • Vaping
  • Nicotine Absorption

Interventions

OTHER

E-cigarette

Subject's own e-cigarette

OTHER

P4M3-1.7%

P4M3 e-liquid concentration of 1.7% nicotine without lactic acid

OTHER

P4M3-1.7%LA

P4M3 e-liquid concentration of 1.7% nicotine with lactic acid

OTHER

P4M3-3%LA

P4M3 e-liquid concentration of 3% nicotine with lactic acid

OTHER

P4M3-4%LA

P4M3 e-liquid concentration of 4% nicotine with lactic acid

Sponsors & Collaborators

  • Philip Morris Products S.A.

    lead INDUSTRY

Principal Investigators

  • Christelle Haziza, PhD · Philip Morris Products S.A.

  • Jonathan Austin, MD · High Point Clinical Trials Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-11
Primary Completion
2017-08-14
Completion
2017-12-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03379740 on ClinicalTrials.gov