A Study To Characterize The Pharmacokinetics Of Oxycodone In Healthy Volunteers

Pain Clinical Trial

Official title:

Open-Label, Single-Dose, Randomized, Crossover Study To Evaluate The Pharmacokinetics Of Oxycodone Following Oral Administration Of PF-00345439 Under Fed Conditions In Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552863
• Other study ID #: B4501018
• Status: Completed
• Phase: Phase 1
• First received: March 9, 2012
• Last updated: August 28, 2015
• Start date: March 2012
• Est. completion date: September 2012

Study information

• Verified date: August 2015
• Source: Pain Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Oxycodone
One capsule of 40 mg PF-00345439 Formulation A, single dose
• Oxycodone
One capsule of 40 mg PF-00345439 Formulation E, single dose
• Oxycodone
One capsule of 40 mg PF-00345439 Formulation F, single dose
• Oxycodone
One capsule of 40 mg PF-00345439 Formulation G, single dose
• Oxycodone
One capsule of 5 mg PF-00345439 Formulation TBD, single dose
• Oxycodone
One capsule of 40 mg PF-00345439 Formulation H, single dose

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pain Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)]		0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.	No
Primary	Maximum Observed Plasma Concentration (Cmax)		0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.	No
Secondary	Maximum Observed Plasma Concentration (Cmax) of Oxycodone in Treatment E		0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.	No
Secondary	Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)] of Oxycodone in Treatment E		0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.	No
Secondary	Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast)		0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.	No
Secondary	Plasma Concentration 24 Hours Post-Dose (C24)		0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post-dose.	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.	No
Secondary	Plasma Decay Half-Life (t1/2)		0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.	No

External Links

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