addicted to smoking/nicotine smokers
Conditions
Interventions
1) Low dose varenicline:
0.5 mg QD during 14 days [Regimen A] for the low weight group or
0.5 mg QD and 0.5 mg BID during 7 days [Regimen B] for the high weight group
2) High dose varenicline:
0.5 mg QD and 0.5 mg BID during 7 days [Regimen B] for the low weight group or
0.5 mg QD during 3 days, 0.5 mg BID during 4 days, and 1 mg BID during 7 days
[Regimen C] for
3) or Placebo during 14 days
Sponsors
Pfizer
Eligibility
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1.Healthy male and female adolescent subjects between the ages of 12 and 16 years. 2. Total body-weight >=30 kg (66 lbs), BMI
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Population mean estimate for apparent plasma clearance (CL/F), central volume of distribution (V2/F) and steady-state volume of distribution (Vss/F) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Individual predicted estimates of Cmax, Tmax, and AUC* on Day 14 (steady-state) using the final PK model and individual post-hoc estimates of the PK parameters 2) Safety laboratory tests, vital signs, ECGs, and adverse events 3) Daily number of cigarettes smoked | — |
Countries
Netherlands
Outcome results
None listed