Dose Proportionality Study Of PF-00345439 Formulation Under Fed Conditions

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Oxycodone

• Registration Number: NCT02089295
• Lead Sponsor: Pain Therapeutics

Brief Summary

To evaluate the dose proportionality of 5 mg, 20 mg and 40 mg of PF 00345439 formulation under fed conditions in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-13
• Study First Submitted QC: 2014-03-13
• Study First Posted: 2014-03-17
• Study Start: 2014-04
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-31
• Last Update Posted: 2016-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Healthy male and/or female subjects between 18 and 55 years of age

Exclusion Criteria

• Evidence or history of clinically significant disease.
• Positive urine drug test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment C	Oxycodone	Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
Treatment A	Oxycodone	Single dose of 5 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
Treatment B	Oxycodone	Single dose of 20 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).

Primary Outcome Measures

Name	Time	Method
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48	AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Maximum Observed Plasma Concentration (Cmax)	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Plasma Decay Half-Life (t1/2)	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Concentration at time 24 hours (C24)	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
Time to Reach Maximum Observed Plasma Concentration (Tmax)	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Overland Park, Kansas, United States