Pharmacokinetics Study of ALO-02 and OxyContin

PHASE1CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

May 31, 2012

Study Completion Date

May 31, 2012

Conditions
Management of Moderate to Severe Pain
Interventions
DRUG

ALO-02

Day 1 (40 mg ALO-02 capsule, single dose) Days 2-5 (40 mg ALO-02 capsule, twice daily)

DRUG

Naltrexone block

Naltrexone Hcl 50 mg tablet will be administered (1) 12.5 hours prior to, 30 minutes prior to, and 11.5 hours after Day 1 dosing, (2) 30 minutes prior to each dose of study drug on Days 2-5 dosing, (3) 11.5 hours after Day 5 PM dosing

DRUG

ALO-02

Day 1 (80 mg ALO-02 capsule, single dose) Days 2-5 (80 mg ALO-02 capsule, once daily)

DRUG

Naltrexone block

Naltrexone Hcl 50 mg tablet will be administered (1) 12.5 hours prior to, 30 minutes prior to, and 11.5 hours after Day 1 dosing, (2) 30 minutes prior to each dose and 11.5 hours after the AM dosing on Days 2-5, (3) 23.5 hours after Day 5 dosing.

DRUG

OxyContin

Day 1 (40 mg OxyContin tablet, single dose) Days 2-5 (40 mg OxyContin tablet, twice daily)

DRUG

Naltrexone block

Naltrexone Hcl 50 mg tablet will be administered (1) 12.5 hours prior to, 30 minutes prior to, and 11.5 hours after Day 1 dosing, (2) 30 minutes prior to each dose of study drug on Days 2-5 dosing, (3) 11.5 hours after Day 5 PM dosing

Trial Locations (1)

06511

Pfizer Investigational Site, New Haven

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT01557257 - Pharmacokinetics Study of ALO-02 and OxyContin | Biotech Hunter | Biotech Hunter