Skip to main content

Table 1 Study endpoints

From: A randomised, controlled, two-Centre open-label study in healthy Japanese subjects to evaluate the effect on biomarkers of exposure of switching from a conventional cigarette to a tobacco heating product

BoE

Abbreviation

Associated Toxicant

Matrix

 Carbon monoxide

CO

Carbon monoxide

Exhaled breath

 Total nicotine equivalents (nicotine, cotinine, 3-hydroxycotinine and their glucuronide conjugates)

TNeq

Nicotine

Urine

 Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol

Total NNAL

4 (methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK)

Urine

 Total N-nitrosonornicotine

Total NNN

NNN

Urine

 3-hydroxypropylmercapturic acid

3-HPMA

Acrolein

Urine

 3-hydroxy-1-methylpropylmercapturic acid

HMPMA

Crotonaldehyde

Urine

 S-phenylmercapturic acid

S-PMA

Benzene

Urine

 Monohydroxybutenyl-mercapturic acid

MHBMA

1,3-butadiene

Urine

 2-cyanoethylmercapturic acid

CEMA

Acrylonitrile

Urine

 4-aminobiphenyl

4-ABP

4-Aminobiphenyl

Urine

 o-toluidine

o-Tol

o-Toluidine

Urine

 2-aminonaphthalene

2-AN

2-Aminonaphthalene

Urine

 1-hydroxypyrene

1-OHP

Pyrene

Urine

 2-hydroxyethylmercapturic acid

HEMA

Ethylene oxide

Urine

 N-acetyl-S-(2-carbamoylethyl)cysteine and N-acetyl-S-(2-hydroxy-2-carbamoylethyl)cysteine

AAMA and GAMA

Acrylamide

Urine

BoBE

Abbreviation

Biological Effect

Matrix

 8-Epi-Prostaglandin F2α Type III

8-Epi-PGF2α Type III

Oxidative stress

Urine

 White blood cell count

WBC count

Inflammation

Whole blood

Nicotine pharmacokinetic parameters

Abbreviation

 Time to maximum observed plasma concentration for nicotine

tmax

 Maximum observed plasma concentration for nicotine

Cmax

 Area under the nicotine plasma concentration-time curve from time zero to the last measurable concentration

AUC0-last

Safety parameters

Other measures

 Medical history of study subjects

Product satisfaction questionnaire

 Physical examination

Puff count during pharmacokinetic assessment period

 Vital signs

Creatinine concentration (24-h urine)

 Electrocardiogram (ECG)

Product use during exposure phase

 Clinical laboratory evaluations

Nicotine molar metabolite ratio

 Lung function test

 

 Adverse event /serious adverse event recording

 
  1. BoE biomarker of exposure, BoBE biomarker of biological effect