Pharmacokinetics And Relative Bioavailability Study Of Oxycodone in Healthy Volunteers

• Sponsor: Pain Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01717027
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arms: 4
• Duration (Months): 2
• Patients Per Site Per Month: 9.5

Study Details

Study Description

Brief Summary

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

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

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 Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: 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
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 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 A, single dose, taken whole and under fed 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 J, single dose, taken whole and under fed 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, taken whole and under fed 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 J or K, single dose, chewed and under fasted conditions

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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

1. 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]

2. 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]

3. 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]

4. 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]

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	New Haven	Connecticut	United States	06511

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: NCT01717027
• Other Study ID Numbers: B4501034
• First Posted: Oct 30, 2012
• Last Update Posted: Aug 31, 2015
• Last Verified: Aug 1, 2015

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

Study Results

No Results Posted as of Aug 31, 2015