PHASE 1, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE MULTIPLE-DOSE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF VARENICLINE IN HEALTHY ADOLESCENT SMOKERS
- Conditions
- addicted to smoking/nicotinesmokers10024450
- Registration Number
- NL-OMON31381
- Lead Sponsor
- Pfizer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 10
1.Healthy male and female adolescent subjects between the ages of 12 and 16 years.
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.
Zie voor overige inclusiecriteria protocol pag. 19
1. Subjects with evidence or history of clinically significant hematological, renal,
endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric,
neurologic, or allergic disease.
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.
Zie voor overige exclusiecriteria protocol pag. 20-21
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1) Population mean estimate for apparent plasma clearance (CL/F), central<br /><br>volume of distribution (V2/F) and steady-state volume of distribution (Vss/F)</p><br>
- Secondary Outcome Measures
Name Time Method <p>1) Individual predicted estimates of Cmax, Tmax, and AUC* on Day 14<br /><br>(steady-state) using the final PK model and individual post-hoc estimates of<br /><br>the PK parameters<br /><br>2) Safety laboratory tests, vital signs, ECGs, and adverse events<br /><br>3) Daily number of cigarettes smoked</p><br>