Abuse Potential Study of PF-00345439

NCT01986283 | Completed Phase 1

• 1 other identifier: B4501016
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine the relative abuse potential of intact and chewed PF-00345439 (Oxycodone Extended-Release Capsules) compared to crushed oxycodone HCL immediate release (IR) tablets and placebo administered orally to non-dependent, recreational opioid users.

Conditions

Opioid Users

Keywords

Abuse potential; PF-00345439; drug abuse

Outcome Measures

Primary Outcomes (4)

• Drug Liking: Peak Effect (Emax)

  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 mm unipolar visual analogue scale (VAS); where 0 mm = Not at all and 100 mm = Extremely.

  12 hours

• High: Peak Effect (Emax)

  High assesses the degree that a subject feels a good effect (ie euphoria) at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar scale); where 0 mm = Not at all and 100 mm = Extremely.

  12 hours

• Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours

  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 mm unipolar visual analogue scale (VAS); where 0 mm = Not at all and 100 mm = Extremely.

  2 hours

• High: Area Under Effect Curve (AUE) From 0-2 Hours

  High assesses the degree that a subject feels a good effect (ie euphoria) at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar scale); where 0 mm = Not at all and 100 mm = Extremely.

  2 hours

Secondary Outcomes (67)

• Take Drug Again Effect at 24 Hours

  24 hours

• Overall Drug Liking

  24 hours

• Any Drug Effects: Area Under Drug Effect Curve (AUE) From 0-1 Hour

  1 hour

• Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour

  1 hour

• Chewing Duration

  5 min

Study Arms (4)

Treatment A

PLACEBO COMPARATOR

Placebo solution +placebo capsule + placebo capsule chewed.

Drug: Capsule

Treatment B

EXPERIMENTAL

PF-00345439 taken whole + placebo solution + placebo chewed

Drug: PF-00345439

Treatment C

EXPERIMENTAL

PF-00345439 chewed + placebo solution + placebo taken whole

Drug: PF-00345439

Treatment D

ACTIVE COMPARATOR

Oxycodone HCl immediate-release 40 mg tablets (eg, 2 x 5 mg + 1 x 30 mg) + placebo taken whole + placebo chewed

Drug: oxycodone

Interventions

Capsule DRUG

Taken once

Treatment A

PF-00345439 DRUG

40 mg capsule swallowed whole, taken once

Treatment B

oxycodone DRUG

40 mg solution, taken once

Treatment D

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and/or female subjects between the ages of 18 and 55 years who are recreational opioid users and are NOT dependent on opioids.

You may not qualify if:

• Evidence or history of clinically significant medical conditions.
• Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine).
• Has participated in, is currently participating in, or is seeking treatment for substance-and/or alcohol-related disorders (excluding nicotine and caffeine).
• Has a positive urine drug screen (UDS) excluding tetrahydrocannabinol (THC).
• Has a positive alcohol breath test.
• Has any history of a condition in which an opioid is contraindicated.
• History of sleep apnea in the past 5 years that has not been resolved or corrected.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results .
• Positive test for Hepatitis B, Hepatitis C, or HIV.
• Allergy or history of hypersensitivity to naloxone HCl, oxycodone HCl, other opioids, and/or lactose.
• Any condition possibly affecting drug absorption (eg, gastrectomy).

Sponsors & Collaborators

• Pain Therapeutics: lead

Study Sites (1)

Lifetree Clinical Research

Salt Lake City, Utah, 84106, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Capsules; Oxycodone

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2013
• First Posted: November 18, 2013
• Study Start: November 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: April 4, 2016

Record last verified: 2016-03

Locations

US (1)