A Study to Characterize the Abuse Liability of Intravenous Oxycodone Alone or in Combination With Intravenous Naltrexone in Healthy, Non-Dependent, Recreational Opioid Users

October 7, 2013 updated by: Pfizer

A Randomized, Single-Dose, Placebo-Controlled, Double-Blind, 3-Way Crossover Study to Determine the Relative Abuse Potential of Intravenous Oxycodone Hydrochloride Alone or in Combination With Intravenous Naltrexone Hydrochloride in Opioid Experienced Non-Dependent Subjects

The main purpose of this study is to simulate if oxycodone and naltrexone combination capsules (ALO-02) were to be tampered with by dissolving and then injecting intravenously for the purpose of getting high.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy subjects
  • Non-dependent, recreational opioid users
  • Must include at least one of these routes of administration: intranasal use on at least 3 occassions in the past year or intravenous use on at least 1 occasion in the past year before Screening (Visit 1).

Exclusion Criteria:

  • Diagnosis of substance and/or alcohol dependence
  • Subject has participated in, is currently participating in, or seeking treatment for substance and/or alcohol related disorder
  • History of sleep apnea.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Treatment A
Drug: Placebo
0.9% sodium chloride for injection x 1 dose administered intravenously (IV) push over 4 min.
EXPERIMENTAL: Treatment B
Drug: Oxycodone + Naltrexone
Oxycodone hydrochloride (HCl) 20 mg IV and naltrexone HCl 2.4 mg IV administered simultaneously x 1 dose IV push over 4 min.
ACTIVE_COMPARATOR: Treatment C
Drug: Oxycodone
Oxycodone HCl 20 mg for injection x 1 dose IV push over 4 min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours
Time Frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100-point bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of
5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Drug Liking: Peak Effect (Emax)
Time Frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
High: Area Under Effect Curve (AUE) From 0-2 Hours
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
High VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
High: Peak Effect (Emax)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour
Time Frame: 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100-point bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of
5 min, 15 min, 30 min, 45 min, 1 h post-dose
Drug Liking: Area Under Effect Curve (AUE) From 0-8 Hours
Time Frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
High: Area Under Effect Curve (AUE) From 0-1 Hour
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
High VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
High: Area Under Effect Curve (AUE) From 0-8 Hours
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
Take Drug Again: Peak Effect (Emax)
Time Frame: 12, 24 h post-dose
Take Drug Again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100-point bipolar VAS with score ranging from 0 mm to 100 (score of 0 =
12, 24 h post-dose
Take Drug Again: Mean Effect (Emean)
Time Frame: 12, 24 h post-dose
12, 24 h post-dose
Overall Drug Liking: Peak Effect (Emax)
Time Frame: 12, 24 h post-dose
Overall Drug Liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100-point VAS is used to assess response based on a score ranging from 0 to 100 (0 =
12, 24 h post-dose
Overall Drug Liking: Mean Effect (Emean)
Time Frame: 12, 24 h post-dose
12, 24 h post-dose
Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour
Time Frame: 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Any Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
5 min, 15 min, 30 min, 45 min, 1 h post-dose
Any Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours
Time Frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
Any Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours
Time Frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour
Time Frame: 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Good Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
5 min, 15 min, 30 min, 45 min, 1 h post-dose
Good Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours
Time Frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h
5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h
Good Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours
Time Frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour
Time Frame: 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Bad Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
5 min, 15 min, 30 min, 45 min, 1 h post-dose
Bad Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours
Time Frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h
5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h
Bad Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours
Time Frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Feel Sick VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Feel Sick: Area Under Effect Curve (AUE) From 0-2 Hours
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
Feel Sick: Area Under Effect Curve (AUE) From 0-8 Hours
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
Nausea: Area Under Effect Curve (AUE) From 0-1 Hour
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Nausea VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Nausea: Area Under Effect Curve (AUE) From 0-2 Hours
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
Nausea: Area Under Effect Curve (AUE) From 0-8 Hours
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Sleepy VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
Sleepy: Area Under Effect Curve (AUE) From 0-8 Hours
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Dizzy VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
Dizzy: Area Under Effect Curve (AUE) From 0-8 Hours
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
Any Drug Effects: Peak Effect (Emax)
Time Frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Good Drug Effects: Peak Effect (Emax)
Time Frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Bad Drug Effects: Peak Effect (Emax)
Time Frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Feel Sick: Peak Effect (Emax)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Nausea: Peak Effect (Emax)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Sleepy: Peak Effect (Emax)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Dizzy: Peak Effect (Emax)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants have the size of their pupil measured (in mm) using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions.
pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose
Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose
Pupillometry: Area Under Effect Curve (AUE) From 0-8 Hours
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose
Pupillometry: Peak Effect (Emax)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Pupillometry: Time to Maximum (Peak) Effect (TEmax)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Drug Liking: Time to Maximum (Peak) Effect (TEmax)
Time Frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
High: Time to Maximum (Peak) Effect (TEmax)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Any Drug Effects: Time to Maximum (Peak) Effect (TEmax)
Time Frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Good Drug Effects: Time to Maximum (Peak) Effect (TEmax)
Time Frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax)
Time Frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Sleepy: Time to Maximum (Peak) Effect (TEmax)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Dizzy: Time to Maximum (Peak) Effect (TEmax)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Nausea: Time to Maximum (Peak) Effect (TEmax)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Feel Sick: Time to Maximum (Peak) Effect (TEmax)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Plasma Concentration of Oxycodone 5 Minutes Post-Dose (C5min)
Time Frame: pre-dose, 5 min post-dose
pre-dose, 5 min post-dose
Plasma Concentration of Oxymorphone 5 Minutes Post-Dose (C5min)
Time Frame: pre-dose, 5 min post-dose
pre-dose, 5 min post-dose
Plasma Concentration of Noroxycodone 5 Minutes Post-Dose (C5min)
Time Frame: pre-dose, 5 min post-dose
pre-dose, 5 min post-dose
Plasma Concentration of Naltrexone 5 Minutes Post-Dose (C5min)
Time Frame: pre-dose, 5 min post-dose
pre-dose, 5 min post-dose
Plasma Concentration of 6-beta-naltrexol 5 Minutes Post-Dose (C5min)
Time Frame: pre-dose, 5 min post-dose
pre-dose, 5 min post-dose
Plasma Decay Half-Life (t1/2) of Oxycodone
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Plasma Decay Half-Life (t1/2) of Oxymorphone
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Plasma Decay Half-Life (t1/2) of Noroxycodone
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Plasma Decay Half-Life (t1/2) of Naltrexone
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Plasma Decay Half-Life (t1/2) of 6-beta-naltrexol
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Oxycodone Concentration-Time Curve (AUC0-1h)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
AUC is a measure of the plasma concentration of the drug over time.
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Oxymorphone Concentration-Time Curve (AUC0-1h)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Noroxycodone Concentration-Time Curve (AUC0-1h)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Naltrexone Concentration-Time Curve (AUC0-1h)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-1h)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Oxycodone Concentration-Time Curve (AUC0-2h)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Oxymorphone Concentration-Time Curve (AUC0-2h)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Noroxycodone Concentration-Time Curve (AUC0-2h)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Naltrexone Concentration-Time Curve (AUC0-2h)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-2h)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Oxycodone Concentration-Time Curve (AUC0-8h)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Oxymorphone Concentration-Time Curve (AUC0-8h)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Noroxycodone Concentration-Time Curve (AUC0-8h)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Naltrexone Concentration-Time Curve (AUC0-8h)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-8h)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Curve From Time Zero to Last Quantifiable Oxycodone Concentration (AUClast)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Curve From Time Zero to Last Quantifiable Oxymorphone Concentration (AUClast)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Curve From Time Zero to Last Quantifiable Noroxycodone Concentration (AUClast)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Curve From Time Zero to Last Quantifiable Naltrexone Concentration (AUClast)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Curve From Time Zero to Last Quantifiable 6-beta-naltrexol Concentration (AUClast)
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Oxycodone
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Oxymorphone
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Noroxycodone
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Naltrexone
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for 6-beta-naltrexol
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Systemic Clearance (Cl) of Oxycodone
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Systemic Clearance (Cl) of Oxymorphone
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Systemic Clearance (Cl) of Noroxycodone
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Systemic Clearance (Cl) of Naltrexone
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Systemic Clearance (Cl) of 6-beta-naltrexol
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Volume of Distribution at Steady State (Vss) for Oxycodone
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Volume of Distribution at Steady State (Vss) for Oxymorphone
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Volume of Distribution at Steady State (Vss) for Noroxycodone
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Volume of Distribution at Steady State (Vss) for Naltrexone
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Volume of Distribution at Steady State (Vss) for 6-beta-naltrexol
Time Frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

Lifetree Clinical Research Center, Salt Lake City, Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

April 2, 2013

First Submitted That Met QC Criteria

April 2, 2013

First Posted (ESTIMATE)

April 5, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 8, 2013

Last Update Submitted That Met QC Criteria

October 7, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B4981002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe