PHASE 1, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE MULTIPLE-DOSE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF VARENICLINE IN HEALTHY ADOLESCENT SMOKERS - N/A

• Conditions: Smoking cessation; MedDRA version: 9.1Level: LLTClassification code 10053325Term: Smoking cessation therapy

• Registration Number: EUCTR2007-001767-30-NL
• Lead Sponsor: Pfizer Inc, 235 East 42nd Street, New York, NY 10017, United States

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
1. Healthy male and female adolescent subjects between the ages of 12 and 16 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
2. Total body weight =30 kg (66 lbs), BMI =30 kg/m2.
3. Subjects must be currently smoking and have smoked an average of at least 3 cigarettes per day during the past 4 weeks.
4. Subjects must have a urine or blood cotinine measurement greater than 100 ng/mL indicating that they are a smoker.
5. For each subject the parent(s)/legal guardian(s) must be willing and able to provide a signed and dated written informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial. Assent of the subjects will be obtained.
6. Subjects and if required by local/site regulations their parent(s)/legal guardian(s) must be willing and able to be confined to the clinical research unit as required by the protocol and be willing to return to the clinical research unit for scheduled visits, treatment, laboratory tests and other out-patient procedures as required by the protocol.

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

Exclusion Criteria

Subjects presenting with any of the following will not be included in the trial:
1. Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including serious drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
2. History of febrile illness within 5 days prior to the first dose.
3. Subjects with any condition possibly affecting drug absorption, eg, gastrectomy.
4. Subjects with a positive urine drug screen.
5. Female subjects with a positive pregnancy test (all female subjects who had attained menarche are required to have pregnancy test).
6. Pregnant or nursing female subjects; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in Section 4.4.4 in the protocol from at least 14 days prior to study medication administration until completion of follow-up procedures.
7. History of regular alcohol consumption exceeding 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
8. Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
9. Screening 12 lead ECG demonstrating heart rate >100 bpm, QRS >120 msec, QTc >430 msec (males), QTc >450 msec (females) or PR >220 msec.
10. Subjects with an estimated creatinine clearance (CLcr) <80 mL/min/1.73m2, derived using the Schwartz formula:
CLCr (mL/min/1.73m2) = (k x ht)/Scr
where ht is the height (cm), Scr is the serum creatinine and k is an age and gender specific constant for proportionality (k=0.55 for either gender 12 years of age; k=0.55 for females 13-21 years of age, k=0.7 for males 13-21 years of age).
11. Use of prescription (other than oral, transdermal, implanted or injected contraceptives) or nonprescription drugs, vitamins and dietary supplements, within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements must be discontinued 30 days prior to the first dose of study medication. Excluded from this list is acetaminophen at doses of =2 g/day. Other exceptions may be granted by a qualified member of the Pfizer study team.
12. Donation of blood in excess of 280 mL within 56 days prior to dosing.
13. History of sensitivity to heparin or heparin-induced thrombocytopenia (if heparin is used to flush intravenous catheters).
14. Subjects who are unwilling or unable to comply with the Lifestyle Guidelines presented in Section 4.4. of the protocol
15. Subjects and parent(s)/legal guardian(s) who are unable and/or unlikely to be able to comprehend and/or follow the protocol.
16. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: • To characterize the multiple-dose pharmacokinetics of varenicline in adolescent male and female smoking subjects ;Secondary Objective: • To evaluate the safety and tolerability of varenicline in adolescent male and female smoking subjects;Primary end point(s): • Population mean estimate for apparent plasma clearance (CL/F), central volume of distribution (V2/F) and steady-state volume of distribution (Vss/F)