Effects of Ethanol on Oxycodone Pharmacokinetics in Healthy Volunteers
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
1 other identifier
interventional
17
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Jul 2014
Shorter than P25 for phase_1 healthy
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2014
CompletedFirst Posted
Study publicly available on registry
June 18, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedApril 4, 2016
March 1, 2016
1 month
June 10, 2014
March 31, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
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).
0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
Maximum Observed Plasma Concentration (Cmax)
0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
Secondary Outcomes (4)
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
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
Study Arms (2)
Treatment A
EXPERIMENTALTreatment B
EXPERIMENTALInterventions
One capsule of 40 mg PF-00345439 Formulation K, single dose, administered with water, under fasting conditions
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).
Eligibility Criteria
You may qualify if:
- Healthy volunteers
- History of moderate alcohol consumption
- Total body weight exceeding 64 kg
You may not qualify if:
- Evidence or history of clinically significant disease.
- Positive urine drug test
- History of alcoholism or heavy alcohol consumption
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Pfizer Investigational Site
Overland Park, Kansas, 66211, United States
Pfizer Investigational Site
Overland Park, Kansas, 66212, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2014
First Posted
June 18, 2014
Study Start
July 1, 2014
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
April 4, 2016
Record last verified: 2016-03