Pharmacokinetics And Relative Bioavailability Study Of Oxycodone in Healthy Volunteers

Open Label, Single Dose, Randomized, Crossover Study To Evaluate The Pharmacokinetics And Relative Bioavailability Of Oxycodone Following Oral Administration Of 40 Mg Doses Of PF 00345439 Taken Whole Under Fed Conditions And After Chewing Under Fasted Conditions In Healthy Volunteers

To estimate the pharmacokinetics and relative bioavailability of oxycodone after administration of 40 mg doses of PF-00345439 formulations taken whole under fed conditions and after chewing under fasted conditions in healthy volunteers

Study Overview

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

Detailed Description

This study will estimate the pharmacokinetics and relative bioavailability of oxycodone following oral administration of single 40 mg doses of PF-00345439 Formulations J and K compared with the reference PF-00345439 Formulation A, all taken whole and under fed conditions in healthy volunteers.

In addition, the study will estimate the pharmacokinetics and relative bioavailability of oxycodone followingoral administration of single 40 mg doses of PF-00345439 Formulation J or K (to beselected based on Periods 1-3) after chewing under fasted conditions compared to that taken whole in the fed state in healthy volunteers, and assess the single-dose safety and tolerability of oxycodone inPF-00345439 formulations in healthy volunteers when administered under a naltrexone block.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• 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

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 A, single dose, taken whole and under fed conditions; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation J, single dose, taken whole and under fed conditions; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation K, single dose, taken whole and under fed conditions; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation J or K, single dose, chewed and under fasted 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 A, single dose, taken whole and under fed conditions; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation J, single dose, taken whole and under fed conditions; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation K, single dose, taken whole and under fed conditions; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation J or K, single dose, chewed and under fasted 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 A, single dose, taken whole and under fed conditions; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation J, single dose, taken whole and under fed conditions; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation K, single dose, taken whole and under fed conditions; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation J or K, single dose, chewed and under fasted 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 A, single dose, taken whole and under fed conditions; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation J, single dose, taken whole and under fed conditions; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation K, single dose, taken whole and under fed conditions; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation J or K, single dose, chewed and under fasted conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) (if data permit, otherwise Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUClast]) of oxycodone.	0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose
Maximum Observed Plasma Concentration (Cmax)	0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of oxycodone, as data permit	0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of oxycodone, as data permit.	0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose
Plasma Decay Half-Life of oxycodone, as data permit.	0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose
Concentration at time 24 hours (C24) of oxycodone, as data permit.	0, 0.5, 1, 2, 4, 6, 8, 12, 14, 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: November 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: October 26, 2012
• First Submitted That Met QC Criteria: October 26, 2012
• First Posted (Estimate): October 30, 2012

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; 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: B4501034