Abuse Potential Study of PF-00345439

Pain Therapeutics

Status and phase: Completed; Phase 1

Conditions: Opioid Users

Treatments: Drug: Capsule; Drug: oxycodone; Drug: PF-00345439

Study type: Interventional

Funder types: Industry

Identifiers

NCT01986283

B4501016

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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67 participants in 4 patient groups, including a placebo group

Treatment A

Placebo Comparator group

Description:

Placebo solution +placebo capsule + placebo capsule chewed.

Treatment:

Drug: Capsule

Treatment B

Experimental group

Description:

PF-00345439 taken whole + placebo solution + placebo chewed

Treatment:

Drug: PF-00345439

Drug: PF-00345439

Treatment C

Experimental group

Description:

PF-00345439 chewed + placebo solution + placebo taken whole

Treatment:

Drug: PF-00345439

Drug: PF-00345439

Treatment D

Active Comparator group

Description:

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

Treatment:

Drug: oxycodone