Effects of Ethanol on Oxycodone Pharmacokinetics in Healthy Volunteers

• Sponsor: Pain Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02165930
• Collaborator: (none)
• Enrollment: 17
• Locations: 2
• Arms: 2
• Duration (Months): 1
• Patients Per Site: 8.5
• Patients Per Site Per Month: 8.3

Study Details

Study Description

Brief Summary

To Estimate Bioavailability Of 40 Mg Doses Of Pf-00345439 Formulation K Under Fasting Conditions with 40% Ethanol Compared with Water in Healthy Volunteers

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: An Open Label, Single Dose, Randomized, Two Way Crossover Study to Estimate Oxycodone Relative Bioavailability in Healthy Volunteers Following Administration of PF 00345439 Formulation K 40 Mg Under Fasting Conditions With 40% Ethanol Compared With Water
• Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A	Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation K, single dose, administered with water, under fasting conditions; Drug: Naltrexone; 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).
Experimental: Treatment B	Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation K, single dose, administered with 40% ethanol, under fasting conditions; Drug: Naltrexone; 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).

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]

   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]

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]

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

2. Concentration at time 24 hours (C24) [0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48]

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]

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy volunteers

• History of moderate alcohol consumption

• Total body weight exceeding 64 kg

Exclusion Criteria:

• Evidence or history of clinically significant disease.

• Positive urine drug test

• History of alcoholism or heavy alcohol consumption

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Overland Park	Kansas	United States	66211
2	Pfizer Investigational Site	Overland Park	Kansas	United States	66212

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: NCT02165930
• Other Study ID Numbers: B4501037
• First Posted: Jun 18, 2014
• Last Update Posted: Apr 4, 2016
• Last Verified: Mar 1, 2016

• Keywords provided by Pain Therapeutics: Bioavailability; oxycodone; ethanol interaction; healthy volunteers
• Additional relevant MeSH terms: Naltrexone; Oxycodone

Study Results

No Results Posted as of Apr 4, 2016