Food Effect And Relative Bioavailability Study Of Oxycodone in Healthy Volunteers

An Open-label, Single-dose, Randomized, Three-way Crossover Study to Estimate the Effects of Food on Oxycodone Pharmacokinetics Following Oral 40 Mg Doses of PF-00345439 Formulation K and to Estimate Its Relative Bioavailability of Oxycodone Compared to PF-003454390 Formulation X in the Fasted State in Healthy Volunteers

To estimate the effects of food on oxycodone pharmacokinetics after administration of 40 mg doses of PF-00345439 Formulation K and to estimate its relative bioavailability compared to PF-00345439 Formulation X in the fasted state in healthy volunteers

Study Overview

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

Detailed Description

This study will estimate the effect of food (standard high-fat breakfast) on the pharmacokineticsand relative bioavailability of oxycodone following oral administration of single 40 mg doses of PF-00345439 Formulation K in healthy volunteers.

Additionally, the study will estimate the pharmacokinetics and relative bioavailability of oxycodone following oral administration of single 40 mg doses of the test PF-00345439 Formulation K compared with the reference PF-00345439 Formulation X under fasted conditions in healthy volunteers and assess the single-dose safety and tolerability of oxycodone in PF-00345439 formulations in healthy volunteers when administered under a naltrexone block.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • 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 (inclusive).

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

3

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 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 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 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 hours post-dose
Maximum Observed Plasma Concentration (Cmax)		0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose

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 hours post-dose
Concentration at time 24 hours (C24) of oxycodone, as data permit.	Concentration at time 24 hours (C24) of oxycodone, as data permit.	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)	Time to Reach Maximum Observed Plasma Concentration (Tmax)	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose
Plasma Decay Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose

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: August 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: August 14, 2013
• First Submitted That Met QC Criteria: August 14, 2013
• First Posted (Estimate): August 16, 2013

Study Record Updates

• Last Update Posted (Estimate): August 31, 2015
• Last Update Submitted That Met QC Criteria: August 28, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: pharmacokinetics; bioavailability; food effect; oxycodone; management of moderate to severe pain
• 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: B4501022