Effects of Ethanol on Oxycodone Pharmacokinetics in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Oxycodone; Drug: Naltrexone

• Registration Number: NCT02165930
• Lead Sponsor: Pain Therapeutics

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-06-12
• Study First Posted: 2014-06-18
• Study Start: 2014-07
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-31
• Last Update Posted: 2016-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment B	Oxycodone	-
Treatment B	Naltrexone	-
Treatment A	Naltrexone	-
Treatment A	Oxycodone	-

Primary Outcome Measures

Name	Time	Method
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).
Maximum Observed Plasma Concentration (Cmax)	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48

Secondary Outcome Measures

Name	Time	Method
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)
Concentration at time 24 hours (C24)	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
Time to Reach Maximum Observed Plasma Concentration (Tmax)	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Overland Park, Kansas, United States