Pharmacokinetic Study Comparing Nicotine Delivery From E-cigarettes and a Conventional Cigarette in Healthy Subjects

NCT02474849 | Completed Early Phase 1

• 1 other identifier: BAT4215006
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare nicotine delivery, heart rate, puffing parameters and product satisfaction in healthy subjects either using several different types of electronic cigarettes or smoking a conventional cigarette.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Plasma nicotine concentration (Cmax)

  Nicotine pharmacokinetics

  -5, 1, 3, 5, 6, 7, 9, 15, 40, and 60 minutes relative to the first puff on the cigarette/e-cigarette

• Plasma nicotine concentration (Tmax)

  Nicotine pharmacokinetics

  -5, 1, 3, 5, 6, 7, 9, 15, 40, and 60 minutes relative to the first puff on the cigarette/e-cigarette

• Plasma nicotine concentration (AUC0-60)

  Nicotine pharmacokinetics

  -5, 1, 3, 5, 6, 7, 9, 15, 40, and 60 minutes relative to the first puff on the cigarette/e-cigarette

Secondary Outcomes (4)

• Change in heart rate

  5 minutes before, during, and 5 minutes after puffing period

• Number of puffs taken

  During 5 minute ad libitum puffing period

• Duration of puffs taken

  During 5 minute ad libitum puffing period

• Subjective measurement of product satisfaction

  After 5 minute product use period

Study Arms (5)

Conventional cigarette

ACTIVE COMPARATOR

Other: Use electronic cigarette or smoke conventional cigarette

First-generation e-cigarette

EXPERIMENTAL

Other: Use electronic cigarette or smoke conventional cigarette

Rechargeable cig-like e-cigarette

EXPERIMENTAL

Other: Use electronic cigarette or smoke conventional cigarette

Closed modular system e-cigarette A

EXPERIMENTAL

Other: Use electronic cigarette or smoke conventional cigarette

Closed modular system e-cigarette B

EXPERIMENTAL

Other: Use electronic cigarette or smoke conventional cigarette

Interventions

Use electronic cigarette or smoke conventional cigarette OTHER

Use of electronic cigarette or smoking conventional cigarette ad libitum for 5 minute period

Closed modular system e-cigarette A; Closed modular system e-cigarette B; Conventional cigarette; First-generation e-cigarette; Rechargeable cig-like e-cigarette

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Prior to study start, subjects must be daily users of newer generation e-cigarette devices which they have used regularly for a minimum of three months. The solutions used in their e-cigarettes must contain nicotine. Subjects must also be occasional smokers of combustible cigarettes (lower limit of 1 cigarette per month; upper limit of 5 cigarettes per week). Product use status will be confirmed with a urinary cotinine level of ≥200ng/ml (determined using NicAlert cotinine test kit) at screening.
• Subjects will be males or non-pregnant, non-lactating females, and between 21 and 55 years of age inclusive. Age verification will be performed by checking of Federal or state-issued ID (e.g. passport or driving licence) during screening.
• Women of child-bearing potential should be using one of the following acceptable methods of contraception : combined (oestrogen and progestogen containing) oral, intravaginal or transdermal hormonal contraception associated with inhibition of ovulation; progestogen-only hormonal contraception, either oral, injected or implanted, associated with inhibition of ovulation; progestogen-only oral hormonal contraception where inhibition of ovulation is not the primary mode of action; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; male or female condom with or without spermicide; cap, diaphragm or sponge with spermicide.
• Women of non-childbearing potential may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for more than 1 year and must have a negative urine pregnancy test result during screening. Women who are surgically sterile must provide documentation of the procedure by an operative report.
• Male subjects must use an approved method of birth control during the entire study. These subjects must not donate sperm during this time.
• Subjects must be in good health as determined by medical history, vital signs, blood biochemistry, haematology, urinalysis and physical examination.
• Subjects must have a body mass index (BMI) between 18 and 30 kg/m2 inclusive. Male subjects must have a weight between 60 and 120kg and female subjects between 50 and 100kg.
• No clinically significant abnormalities in blood pressure values.
• Subjects will have negative results for the urinary drug of abuse screening and ethanol test.
• Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions.
• To be confirmed during each clinic visit:
• \. Abstinence from tobacco and nicotine products will be confirmed by an exhaled breath CO reading \<10ppm.

You may not qualify if:

• Subjects who have a history of, or clinically active significant, neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological disease or other major disorders.
• Subjects with significant allergies who in the opinion of the Principal Investigator should not be included.
• Subjects who have been diagnosed with urticaria (hives) or asthma.
• Persons who have a history of urticaria (hives) in response to any product.
• Subjects with a recent history of or current drug or alcohol abuse who in the opinion of the Investigator should not be included. Excessive intake of alcohol within the last 6 months, defined as a regular maximum weekly intake of greater than 7 drinks for women or 14 drinks for men. One drink is defined as one pint of regular beer (5% alcohol), 200 ml of wine (12% alcohol), or 25 ml of distilled spirits (40% alcohol).
• Subjects with an inability to communicate well with the Investigator/study staff (i.e., language problem, poor mental development or impaired cerebral function).
• Subjects who are participating in another clinical research study or who have participated in a clinical research study in the last 3 months.
• Subjects who have used any drugs or substances (except tobacco) known to be strong inducers or inhibitors of any CYP enzymes (formerly known as cytochrome P450 enzymes) within a 28 days period prior to first product administration. For a list of such drugs and substances, please refer to http://medicine.iupui.edu/clinpharm/ddis/main-table/.
• Subjects who have had any treatment with smoking cessation medications (e.g. Bupropion, Chantix or any NRT) within 30 days of the planned first product use occasion.
• Subjects with any other clinically significant medical history, in the Investigator's opinion, including conditions which might affect drug absorption, metabolism or excretion.
• Female subjects, who are pregnant or become pregnant during the course of the study.
• Subjects who have lost or donated more than 450ml of blood within the 3 months preceding the first product administration.
• Subjects who are currently trying to stop smoking or to stop using e-cigarettes, or considering stopping in the next two months.
• Subjects who are unwilling or unable to comply with the study requirements.
• Subjects who in the opinion of the Investigator should not participate in the study for any other reason.

Sponsors & Collaborators

• British American Tobacco (Investments) Limited: lead
• LA Clinical Trials: collaborator

Study Sites (1)

Los Angeles Clinical Trials

Burbank, California, 91505, United States

Location

Study Officials

• Mitchell Nides, PhD

  Los Angeles Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: June 18, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 15, 2015

Record last verified: 2015-09

Locations

US (1)