Healthy Volunteers Study to Estimate the Effects of Food on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Formulation of Oxycodone With Sequestered Naltrexone

• ClinicalTrials.gov Identifier: NCT01456507
• Recruitment Status: Completed
• First Posted: October 20, 2011
• Last Update Posted: September 28, 2018
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

The purpose of this study is to estimate the effects of food and of sprinkling ALO-02 pellets on applesauce on the bioavailability of oxycodone and naltrexone/6- beta-naltrexol from an extended release pellets-in-capsule formulation of oxycodone 40 mg with sequestered naltrexone 4.8 mg.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: ALO-02 (Oxycodone Naltrexone)	Phase 1

Detailed Description:

Bioavailability

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: An Open-Label, Single-Dose, Randomized, Three-Way Crossover Study in Healthy Volunteers to Estimate the Effects of Food and of Sprinkling ALO-02 Pellets on Applesauce on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Pellets-in-Capsule Formulation of Oxycodone 40 Mg With Sequestered Naltrexone 4.8 Mg
• Study Start Date: October 2011
• Actual Primary Completion Date: January 2012
• Actual Study Completion Date: January 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: A; 1×40 mg ALO-02 capsule administered with 240 mL of water under fasting conditions.	Drug: ALO-02 (Oxycodone Naltrexone); single dose of ALO-02 capsule under fasting condition
Experimental: B; 1×40 mg ALO-02 capsule administered with 240 mL of water under fed conditions (standard high fat breakfast).	Drug: ALO-02 (Oxycodone Naltrexone); single dose of ALO-02 capsule under fed condition
Experimental: C; 1×40 mg ALO-02 with the ALO-02 pellets sprinkled approximately on one table spoon of applesauce, and administered with 240 mL of water under fasting conditions.	Drug: ALO-02 (Oxycodone Naltrexone); ALO-02 with the ALO-02 pellets sprinkled on applesauce, and administered under fasting conditions.

Outcome Measures

Primary Outcome Measures :

1. Area Under the Curve (AUC) to time infinity (inf) of oxycodone [ Time Frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose ]
2. Area Under the Curve (AUC) to last quantifiable concentration (last) of oxycodone [ Time Frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose ]
3. Maximum Plasma Concentration (Cmax) of oxycodone [ Time Frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose ]

Secondary Outcome Measures :

1. C24, Tmax (time at maximum concentration) and half-life of oxycodone, as data permit. [ Time Frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose ]
2. AUClast, AUCinf, and Cmax of naltrexone and 6-beta-naltrexol, as data permit [ Time Frame: predose, 1,2,4,8,12,24,48,120 hours post-dose ]
3. Adverse events, vital signs, pulse oximetry, and safety laboratory parameters. [ Time Frame: over 120 hours ]

Eligibility Criteria

• 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 the ages of 18 and 55 years, inclusive

Exclusion Criteria:

• Evidence or history of clinically significant diseases

Contacts and Locations

Locations

United States, Connecticut

Pfizer Investigational Site

New Haven, Connecticut, United States, 06511

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01456507 History of Changes
• Other Study ID Numbers: B4531003
• First Posted: October 20, 2011
• Last Update Posted: September 28, 2018
• Last Verified: September 2018

Keywords provided by Pfizer:

Food effect; bioavailability; oxycodone; sequestered Naltrexone; management of moderate to severe pain

Additional relevant MeSH terms:

Naltrexone; Oxycodone; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Alcohol Deterrents; Narcotic Antagonists