Pharmacokinetics And Relative Bioavailability Study Of Oxycodone in Healthy Volunteers

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Oxycodone
* Drug: Oxycodone
* Drug: Oxycodone
* Drug: Oxycodone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>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<br>* One capsule of 40 mg PF-00345439 Formulation A, single dose, taken whole and under fed conditions<br>|
| Experimental: Treatment B<br>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<br>* One capsule of 40 mg PF-00345439 Formulation J, single dose, taken whole and under fed conditions<br>|
| Experimental: Treatment C<br>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<br>* One capsule of 40 mg PF-00345439 Formulation K, single dose, taken whole and under fed conditions<br>|
| Experimental: Treatment D<br>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<br>* One capsule of 40 mg PF-00345439 Formulation J or K, single dose, chewed and under fasted conditions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, bioavailability, oxycodone, management of moderate to severe pain