PHARMACODYNAMIC EFFECTS OF NICOTINE MOUTH SPRAY AND CYTISINE TABLET. A STUDY IN HEALTHY SMOKERS.

Phase 1

• Conditions: Tobacco Dependence; Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

• Registration Number: EUCTR2016-001267-36-SE
• Lead Sponsor: McNeil AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-13
• Last Update Posted: 16 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Healthy male or female subject between the ages of 19 and 55 years, inclusive. Health is defined as the absence of clinically relevant abnormalities as judged by the Investigator on the basis of a detailed medical history, physical examination, blood pressure, and pulse rate measurements. The responsible Investigator may request additional investigations or analyses if necessary.
2. Smoking of at least 10 cigarettes daily during at least one year preceding inclusion.
3. Smoking within 30 minutes of waking up.
4. Has a Body Mass Index between 17.5 and 32.0 kg/m2 with a total body weight > 50 kg.
5. Females: Postmenopausal state (absence of menstrual discharge for at least two years and a serum Follicle Stimulating Hormone (FSH) level exceeding 30 IU/L) or premenopausal/perimenopausal state with an effective means of contraception (oral, injected, implanted, transdermal, hormonal contraceptives, vaginal contraceptive ring, intrauterine device, or status after operative sterilization) during the study and 30 days thereafter, single male partner who has had a vasectomy, or abstinence from heterosexual intercourse, during the study and 30 days thereafter.
6. Males: No pregnant spouse or partner at screening and willingness to protect potential spouse or partner from becoming pregnant during the study and 30 days thereafter.
7. A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.
8. Willingness and ability to comply with scheduled visits, treatment plan, and other study procedures specified in the protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 64
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Use of medications other than contraceptives specified in Inclusion Criterion 5 or occasional use of other medications approved by the Investigator.
2. Known sensitivity to any ingredient of the studied formulations.
3. Females: pregnancy and/or breastfeeding.
4. History of alcoholism or substance abuse, as judged by the Investigator, within the past 6 months preceding this study.
5. Treatment with an investigational drug, other than those described in this protocol, within 3 months preceding this study and until the last treatment visit of the study.
6. Use of drugs indicated for smoking cessation or history of a quit attempt within than 3 months preceding the screening visit.
7. Pathological oral status interfering with absorptive function of the oral cavity.
8. Relationship to persons involved directly with the conduct of the study (i.e., PI; sub Investigators; study coordinators; other study personnel; employees or contractors of the sponsor or Johnson & Johnson subsidiaries; and the families of each).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified