Dose Proportionality Study Of PF-00345439 Formulation Under Fed Conditions

Sponsor

Pain Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT02089295

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Oxycodone Drug: Oxycodone Drug: Oxycodone	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

An Open-label, Randomized, Single-dose, Three-way Crossover Study to Evaluate the Dose Proportionality of 5 Mg, 20 Mg and 40 Mg of PF-00345439 Formulation K Under Intermediate-fat Fed Conditions in Healthy Volunteers

Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A 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).	Drug: Oxycodone One capsule of 5 mg PF-00345439 Formulation K, single dose, under fed conditions
Experimental: Treatment B 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).	Drug: Oxycodone One capsule of 20 mg PF-00345439 Formulation K, single dose, under fed conditions
Experimental: Treatment C 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).	Drug: Oxycodone One capsule of 40 mg PF-00345439 Formulation K, single dose, under fed conditions

Arm

Intervention/Treatment

Experimental: Treatment A

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).

Drug: Oxycodone

One capsule of 5 mg PF-00345439 Formulation K, single dose, under fed conditions

Experimental: Treatment B

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).

Drug: Oxycodone

One capsule of 20 mg PF-00345439 Formulation K, single dose, under fed conditions

Experimental: Treatment C

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).

Drug: Oxycodone

One capsule of 40 mg PF-00345439 Formulation K, single dose, under fed conditions

Outcome Measures

Primary Outcome Measures

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

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)
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]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Overland Park	Kansas	United States	66211
2	Pfizer Investigational Site	Overland Park	Kansas	United States	66212

Sponsors and Collaborators

Pain Therapeutics

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

Pain Therapeutics

ClinicalTrials.gov Identifier:

NCT02089295

Other Study ID Numbers:

B4501035

First Posted:

Mar 17, 2014

Last Update Posted:

Apr 4, 2016

Last Verified:

Mar 1, 2016

Keywords provided by Pain Therapeutics

dose proportionality

oxycodone

Additional relevant MeSH terms:

Oxycodone

Study Results

No Results Posted as of Apr 4, 2016