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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-11

Study Completion Date

2017-12-01

Brief Summary

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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.

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Detailed Description

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The goal of the study is to evaluate the nicotine concentration profiles and derived PK parameters, subjective effects, behavioral parameters, including puffing topography parameters of P4M3 with four different variants of P4M3, in experienced e-cigarette users after a single-use experience with fixed puffing regime and after ad libitum use of P4M3.

Four variants of P4M3 will be evaluated together with subjects' own e-cigarettes to evaluate the relationship between the e-liquid composition (nicotine concentrations and presence of lactic acid) and the amount of nicotine absorbed, the speed of absorption, and the puffing topography.

Conditions

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Vaping Nicotine Absorption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

This is an open-label study; however the site (except the pharmacy staff preparing the IPs for administration) will be masked to the randomization sequences until they are assigned. Subjects will not be informed of the complete sequence to which they have been assigned to receive the P4M3 products.

Study Groups

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Product Exposure Sequence 1

Subjects will be randomized to follow a sequence of product exposure comprised of :

Subject's own e-cigarette; P4M3-1.7%; P4M3-1.7%LA; P4M3-3%LA; and P4M3-4%LA

Group Type EXPERIMENTAL

E-cigarette

Intervention Type OTHER

Subject's own e-cigarette

P4M3-1.7%

Intervention Type OTHER

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

P4M3-1.7%LA

Intervention Type OTHER

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

P4M3-3%LA

Intervention Type OTHER

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

P4M3-4%LA

Intervention Type OTHER

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

Product Exposure Sequence 2

Subjects will be randomized to follow a sequence of product exposure comprised of :

Subject's own e-cigarette; P4M3-1.7%LA; P4M3-1.7%; P4M3-3%LA; and P4M3-4%LA

Group Type EXPERIMENTAL

E-cigarette

Intervention Type OTHER

Subject's own e-cigarette

P4M3-1.7%

Intervention Type OTHER

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

P4M3-1.7%LA

Intervention Type OTHER

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

P4M3-3%LA

Intervention Type OTHER

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

P4M3-4%LA

Intervention Type OTHER

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

Interventions

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E-cigarette

Subject's own e-cigarette

Intervention Type OTHER

P4M3-1.7%

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

Intervention Type OTHER

P4M3-1.7%LA

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

Intervention Type OTHER

P4M3-3%LA

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

Intervention Type OTHER

P4M3-4%LA

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subject has signed the informed consent form (ICF) and is able to understand the information provided in the ICF.
* Subject is 21 to 65 years of age, inclusive, at the Screening Visit.
* Subject is a former daily cigarette smoker who smoked at least 100 cigarettes or more in his/her life and ceased smoking at least 3 months prior to the Screening Visit.
* Subject has been using a commercially available, nicotine-containing closed tank/cartridge e-cigarette daily for at least 3 months prior to the Screening Visit.
* Subject has a urine cotinine test ≥200 ng/mL at the Screening Visit and Admission.

Exclusion Criteria

* Subject has a clinically relevant disease which requires medication which as per the judgment of the Investigator would jeopardize the safety of the subject.
* Subject has abnormal renal function test result or subject with a creatinine clearance \<60 mL/minute at the Screening Visit, confirmed on repeat testing.
* Subject has elevated liver function test results at the Screening Visit.
* Subject has bilirubin \>1.5X ULN at the Screening Visit.
* Subject has FEV1/FVC \<0.7 and FEV1 \<80% predicted value at post-bronchodilator spirometry at the Screening Visit.
* Subject has asthma condition at the Screening Visit.
* Subject has received medication within 14 days or within 5 half-lives of the drug (whichever is longer) prior to Admission, which has an impact on cytochrome P450 (CYP) 2A6 activity.
* Subject has a carbon monoxide (CO) breath test ≥ 10 ppm at the Screening Visit or Admission.
* Subject has a body mass index (BMI) \<18.5 kg/m2 or BMI ≥35 kg/m2 at the Screening Visit.
* Subject has a positive serology test for human immunodeficiency virus (HIV) 1/2, hepatitis B, or hepatitis C at the Screening Visit.
* Subject has clinically significant ECG findings at the Screening Visit.
* Subject has participated in a clinical study within 3 months prior to the Screening Visit.
* Subject smokes cigarettes or uses other tobacco products.
* Female subject of childbearing potential who is pregnant or breastfeeding.
* Female subject of childbearing potential who does not agree to use an acceptable method of effective contraception..

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes