Single-Dose, Crossover Study To Compare Bioavailability Of Two Formulations Under Fed And Fasted Conditions

An Open-Label, Randomized, 2-Cohort, Single-Dose, Crossover Study Of 40 Mg Doses Of Pf-00345439 To Evaluate The Bioequivalence Of Modified Formulation K Vs. Original Formulation X Under Intermediate-Fat Fed Conditions And To Estimate Relative Bioavailability Under Fasting Conditions In Healthy Volunteers

To Compare The Bioavailability Of 40 Mg Doses Of Pf-00345439 Modified Formulation K Vs. Original Formulation X Under Fed And Fasting Conditions In Healthy Volunteers

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Oxycodone; Drug: Oxycodone; Drug: Oxycodone; Drug: Oxycodone

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • St. Paul, Minnesota, United States, 55114
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A; 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; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation X, single dose, under fed conditions; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation X, single dose, under fasting conditions; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation K, single dose, under fasting conditions
Experimental: Treatment B; 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; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation X, single dose, under fed conditions; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation X, single dose, under fasting conditions; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation K, single dose, under fasting 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; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation X, single dose, under fed conditions; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation X, single dose, under fasting conditions; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation K, single dose, under fasting conditions
Experimental: Treatment D; 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; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation X, single dose, under fed conditions; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation X, single dose, under fasting conditions; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation K, single dose, under fasting conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]	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).	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
Maximum Observed Plasma Concentration (Cmax)		0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
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

Collaborators and Investigators

• Sponsor: Pain Therapeutics

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: February 7, 2014
• First Submitted That Met QC Criteria: February 7, 2014
• First Posted (Estimate): February 11, 2014

Study Record Updates

• Last Update Posted (Estimate): April 4, 2016
• Last Update Submitted That Met QC Criteria: March 31, 2016
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: pharmacokinetics; bioavailability; bioequivalence; oxycodone
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Oxycodone
• Other Study ID Numbers: B4501015