Effects of Food on Oxycodone Pharmacokinetics in Healthy Volunteers
An Open-Label, Randomized, 2-Cohort, Single-Dose, Crossover Study To Estimate The Effects Of Food On Oxycodone Pharmacokinetics Following Oral Administration Of 40 Mg Doses Of Pf 00345439 Formulation K Taken Whole Or After Chewing In Healthy Volunteers
1 other identifier
interventional
34
1 country
2
Brief Summary
To estimate the effect of food on the pharmacokinetics and relative bioavailability of oxycodone following oral administration of single 40 mg doses of PF 00345439 Formulation K taken whole or after chewing in healthy volunteers. We have described below the two cohorts each with two arms in this crossover study by listing them as four Arms/Groups in order to capture the differences between the cohorts prior to the crossover and after the crossover. 14 participants are planned for the first cohort and 18 participants are planned for the second cohort.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Apr 2014
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
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 16, 2014
CompletedFirst Posted
Study publicly available on registry
April 21, 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
4 months
April 16, 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 (4)
Treatment A
EXPERIMENTALSingle 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).
Treatment B
EXPERIMENTALSingle 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).
Treatment C
EXPERIMENTALSingle 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).
Treatment D
EXPERIMENTALSingle 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).
Interventions
One capsule of 40 mg PF-00345439 Formulation K, taken whole, single dose, under fasting conditions
Eligibility Criteria
You may qualify if:
- Healthy male and/or female subjects between 18 and 55 years of age
You may not qualify if:
- Evidence or history of clinically significant disease.
- Positive urine drug test
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
April 16, 2014
First Posted
April 21, 2014
Study Start
April 1, 2014
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
April 4, 2016
Record last verified: 2016-03