A Study to Assess the Nicotine Pharmacokinetics, Tolerability and Safety With a New Oral Nicotine Replacement Product in Healthy Japanese Smokers

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Oromucosal Nicotine Spray (ONS); Drug: Nicotine Gum; Other: Cigarette

Study type: Interventional

Funder types: Industry

Identifiers

NCT03398876

10258820TDP1001 (Other Identifier)

CR108422

Details and patient eligibility

About

In Part 1, the purpose of this study is to elucidate the single-dose pharmacokinetic profiles of 1 spray and 2 consecutive sprays of oromucosal nicotine spray (ONS) in comparison with those of nicotine gum and cigarette smoking in healthy Japanese smokers. In Part 2, the purpose is to evaluate the multiple-dose nicotine pharmacokinetics of ONS administered repeated-dose administration in healthy Japanese smokers.

Enrollment: 24 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or female Japanese participants between the ages of 20 and 50 years, inclusive. Health is defined as the absence of clinically relevant abnormalities identified by a detailed medical history, blood pressure, pulse rate measurements, 12-lead electrocardiogram (ECG) as well as clinical laboratory tests, as judged by the principal investigator or sub investigator.
• Smoking of at least 15 cigarettes daily during at least one year preceding inclusion
• Body Mass Index between 17.5 and 30.0 kilogram per square meter (kg/m^2) and a total body weight greater than or equal to (>=) 50.0 kg
• Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study
• All women of childbearing potential, except for postmenopausal females, must have a negative urine beta-human chorionic gonadotropin (beta-hCG) at screening of Part 1 and all planned visits of Part 1 and Part 2

Exclusion criteria

• Evidence or history of an acute or chronic medical or psychiatric condition or allergy or laboratory abnormality, or of use of drugs that, in the judgment of the principal investigator or sub investigator, increase the risk associated with study participation or interfere with the interpretability of study results
• Females: Pregnancy, breast-feeding, premenopausal, or perimenopausal state with insufficient contraception
• Treatment with an investigational drug within 3 months preceding the first dose of study product
• Participant has donated blood or blood product or had substantial loss of blood more than 200 milliliter (mL) within 1 month before study products administration, or greater than or equal to (>=) 400 mL within 3 months for males and 4 months for females before study products administration, or participant has donated a total volume of blood in the past one year exceeding 1,200 mL for males and 800 mL for females, or participant has an intention to donate blood or blood products during the study and for at least 3 months for males and 4 months for females for blood, or at least 2 months for both genders for blood products after completion of the study
• Exclusion Criterion for Only Part 2: participants who is analyzed as cytochrome (CYP)2A6 *4/*4 by CYP2A6 genetic polymorphism test at Visit 1 of Part 1

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

24 participants in 6 patient groups

Part 1; Treatment Sequence ABDC

Experimental group

Description:

Participants will receive Treatment A (one spray of oromucosal nicotine spray \[ONS\]) at Visit 1, then Treatment B (2 consecutive sprays of ONS at Visit 2, then Treatment D (1 cigarette \[10 puffs\]) at Visit 3, followed by Treatment C (nicotine gum) at Visit 4. The visits will be separated by a period of at least 7 calendar days.

Treatment:

Other: Cigarette

Drug: Nicotine Gum

Drug: Oromucosal Nicotine Spray (ONS)

Part 1; Treatment Sequence BCAD

Experimental group

Description:

Participants will receive Treatment B at Visit 1, then Treatment C at Visit 2, then Treatment A at Visit 3 followed by Treatment D at Visit 4. The visits will be separated by a period of at least 7 calendar days.

Treatment:

Other: Cigarette

Drug: Nicotine Gum

Drug: Oromucosal Nicotine Spray (ONS)

Part 1; Treatment Sequence CDBA

Experimental group

Description:

Participants will receive Treatment C at Visit 1, then Treatment D at Visit 2, then Treatment B at Visit 3 followed by Treatment A at Visit 4. The visits will be separated by a period of at least 7 calendar days. The visits will be separated by a period of at least 7 calendar days.

Treatment:

Other: Cigarette

Drug: Nicotine Gum

Drug: Oromucosal Nicotine Spray (ONS)

Part 1; Treatment Sequence DACB

Experimental group

Description:

Participants will receive Treatment D at Visit 1, then Treatment A at Visit 2, then Treatment C at Visit 3 followed by Treatment B at Visit 4. The visits will be separated by a period of at least 7 calendar days.

Treatment:

Other: Cigarette

Drug: Nicotine Gum

Drug: Oromucosal Nicotine Spray (ONS)

Part 2; Treatment Sequence EF

Experimental group

Description:

Participants who complete Part 1 will be selected for Part 2 based on the results of genetic polymorphism test and other examinations. Selected participants will receive Treatment E (two consecutive sprays of ONS once every 30 minutes until 11.5 hours) at Visit 5, followed by Treatment F (two consecutive sprays of ONS once every 1 hour until 11 hours) at Visit 6. The visits will be separated by a period of at least 7 calendar days.

Treatment:

Drug: Oromucosal Nicotine Spray (ONS)

Part 2; Treatment Sequence FE

Experimental group

Description:

Participants who complete Part 1 will be selected for Part 2 based on the results of genetic polymorphism test and other examinations. Selected participants will receive Treatment F at Visit 5 followed by Treatment E at Visit 6. The visits will be separated by a period of at least 7 calendar days.

Treatment:

Drug: Oromucosal Nicotine Spray (ONS)