A Study To Characterize The Pharmacokinetics Of Oxycodone In Healthy Volunteers

Pain Therapeutics

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: Oxycodone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01552863

B4501018

Details and patient eligibility

About

This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 6- dosing period study to characterize the pharmacokinetics of oxycodone (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the body). This study will consist of three parts that will take place over approximately 90 days. Part 1 of the study has 4 dosing periods, while Parts 2 and 3 have one dosing period each.

Full description

This study will estimate the PK and relative BA of oxycodone following single oral 40-mg doses of 3 modified PF-00345439 Formulations E, F, and G compared with the reference PF-00345439 Formulation A under fed conditions in healthy volunteers in order to aid in selection of a final formulation.

Enrollment: 21 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.
• History of obstructive sleep apnea.
• Positive urine drug test.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 6 patient groups

Treatment A

Experimental group

Description:

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:

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Treatment B

Experimental group

Description:

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:

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Treatment C

Experimental group

Description:

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:

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Treatment D

Experimental group

Description:

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:

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Treatment E

Experimental group

Description:

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:

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Treatment F

Experimental group

Description:

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:

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone