A Phase 1, Investigator And Subject Blind (Sponsor Open), Randomized, Placebo Controlled, Parallel Group, Multiple Dose Escalation Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Varenicline Amt-8 Controlled Release Formulation In Adult Smokers

NCT00527150 Phase 1 COMPLETED

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of escalating multiple oral doses of varenicline AMT 8 controlled release formulation for 14 days in adult smokers.

Details

Lead sponsor	Pfizer
Phase	Phase 1
Status	COMPLETED
Enrolment	48
Start date	2007-10
Completion	2008-02

Conditions

• Smoking Cessation

Interventions

• Varenicline Tartrate
• Varenicline Tartrate
• Varenicline Tartrate
• Varenicline Tartrate
• Varenicline Tartrate

Primary outcomes

• Pharmacokinetic endpoints include varenicline area under the curve from 0-24 hours (AUC24), maximum plasma concentration (Cmax), — Day 1 and Day 14
• Safety endpoints include evaluation of clinical safety laboratory tests, supine vital signs, triplicate 12-lead ECGs and adverse events. — up to 14 days
• Time of maximum plasma concentration (Tmax) on Day 1 and Day 14 — Day 1 and Day 14
• Minimum plasma concentration (Cmin), terminal half life (t1/2), observed accumulation ratio (Rac), peak:trough fluctuation (%PTF) on Day 14 only. — Day 14

Countries

United States