Food Effect And Relative Bioavailability Study Of Oxycodone in Healthy Volunteers

• Sponsor: Pain Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01924676
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 3
• Duration (Months): 2
• Patients Per Site Per Month: 9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Oxycodone; Drug: Oxycodone; Drug: Oxycodone	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: 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
• Study Start Date: Aug 1, 2013
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

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 X, 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 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

Outcome Measures

Primary Outcome Measures

1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose]

   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).

2. 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

1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose]

   Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

2. 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]

   Concentration at time 24 hours (C24) of oxycodone, as data permit.

3. 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]

   Time to Reach Maximum Observed Plasma Concentration (Tmax)

4. Plasma Decay Half-Life (t1/2) [0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose]

   Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Baltimore	Maryland	United States	21225

Sponsors and Collaborators

• Pain Therapeutics

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pain Therapeutics
• ClinicalTrials.gov Identifier: NCT01924676
• Other Study ID Numbers: B4501022
• First Posted: Aug 16, 2013
• Last Update Posted: Aug 31, 2015
• Last Verified: Aug 1, 2015

• Keywords provided by Pain Therapeutics: food effect; pharmacokinetics; bioavailability; oxycodone; management of moderate to severe pain
• Additional relevant MeSH terms: Oxycodone

Study Results

No Results Posted as of Aug 31, 2015