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Dose Proportionality Study Of PF-00345439 Formulation Under Fed Conditions

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ClinicalTrials.gov Identifier: NCT02089295
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : April 4, 2016
Sponsor:
Information provided by (Responsible Party):
PainT ( Pain Therapeutics )

Study Description
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Brief Summary:
To evaluate the dose proportionality of 5 mg, 20 mg and 40 mg of PF 00345439 formulation under fed conditions in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: Oxycodone Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-label, Randomized, Single-dose, Three-way Crossover Study to Evaluate the Dose Proportionality of 5 Mg, 20 Mg and 40 Mg of PF-00345439 Formulation K Under Intermediate-fat Fed Conditions in Healthy Volunteers
Study Start Date : April 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment A
Single dose of 5 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).
 Drug: Oxycodone
One capsule of 5 mg PF-00345439 Formulation K, single dose, under fed conditions
Experimental: Treatment B
Single dose of 20 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).
 Drug: Oxycodone
One capsule of 20 mg PF-00345439 Formulation K, single dose, under fed conditions
Experimental: Treatment C
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).
 Drug: Oxycodone
One capsule of 40 mg PF-00345439 Formulation K, single dose, under fed conditions


Outcome Measures
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Primary Outcome Measures :
  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 ]
  4. Plasma Decay Half-Life (t1/2) [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and/or female subjects between 18 and 55 years of age

Exclusion Criteria:

  • Evidence or history of clinically significant disease.
  • Positive urine drug test
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089295


Locations
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United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Pain Therapeutics
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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Responsible Party: Pain Therapeutics
ClinicalTrials.gov Identifier: NCT02089295     History of Changes
Other Study ID Numbers: B4501035
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: April 4, 2016
Last Verified: March 2016
Keywords provided by PainT ( Pain Therapeutics ):
dose proportionality
oxycodone
Additional relevant MeSH terms:
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Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
 Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents