NCT01557257

Brief Summary

To characterize the single- and multiple-dose pharmacokinetics of oxycodone following the administration of ALO-02 40 Mg Twice Daily, ALO-02 80 Mg Once Daily or Oxycontin 40 Mg Twice Daily in Healthy Volunteers

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

June 28, 2012

Status Verified

June 1, 2012

Enrollment Period

2 months

First QC Date

March 15, 2012

Last Update Submit

June 26, 2012

Conditions

Management of Moderate to Severe Pain

Keywords

single- and multiple-dose pharmacokineticsALO-02OxyContin

Outcome Measures

Primary Outcomes (12)

  • Single-dose administration: Maximum Observed Plasma Concentration (Cmax) of oxycodone

    0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing

  • Single-dose administration: Area under the plasma concentration versus time curve from time zero to 24 hours (AUC24) of oxycodone

    0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing

  • Single-dose administration: Time to Reach Maximum Observed Plasma Concentration (Tmax) of oxycodone

    0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing

  • Multiple-dose administration: Area under the plasma concentration versus time curve from time zero to 24 hours (AUC24) of oxycodone, as data permit.

    96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing

  • Multiple-dose administration: Area under the plasma concentration versus time curve within a dosing interval of τ at steady state (AUCτ) of oxycodone, as data permit.

    96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing

  • Multiple-dose administration: Maximum plasma concentration at steady state on Day 5 (Cmax,ss) of oxycodone, as data permit.

    96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing

  • Multiple-dose administration: Minimum plasma concentration at steady state on Day 5 (Cmin,ss) of oxycodone, as data permit.

    96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing

  • Multiple-dose administration: Average plasma concentration at steady state on Day 5 (Cave,ss) of oxycodone, as data permit.

    96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing

  • Multiple-dose administration: Time to Reach Maximum Observed Plasma Concentration on Day 5 (Tmax) of oxycodone, as data permit.

    96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing

  • Multiple-dose administration: Plasma Decay Half-Life (t1/2) of oxycodone, as data permit.

    96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing

  • Multiple-dose administration: Peak to trough fluctuation at steady state (PTF) of oxycodone, as data permit.

    96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing

  • Multiple-dose administration: Accumulation ratio based on Area Under Curve (AUC) (Rac) of oxycodone, as data permit.

    96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing

Secondary Outcomes (17)

  • Single-dose administration: Dose normalized Maximum Observed Plasma Concentration (Cmax(dn)) of oxycodone, noroxycodone, and oxymorphone.

    0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing

  • Single-dose administration: Dose-normalized Area under the plasma concentration versus time curve from time zero to 24 hours (AUC24(dn)) of oxycodone, noroxycodone, and oxymorphone.

    0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing

  • Single-dose administration: Maximum Observed Plasma Concentration (Cmax) of noroxycodone and oxymorphone.

    0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing

  • Single-dose administration: Area under the plasma concentration versus time curve from time zero to 24 hours (AUC24) of noroxycodone and oxymorphone.

    0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing

  • Single-dose administration: Time to Reach Maximum Observed Plasma Concentration (Tmax) of noroxycodone and oxymorphone.

    0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing

  • +12 more secondary outcomes

Study Arms (3)

40 mg ALO-02 capsule

EXPERIMENTAL

Single- and multiple-dose of 40 mg ALO-02 capsule under 50 mg naltrexone block

Drug: ALO-02Drug: Naltrexone block

80 mg ALO-02 capsule

EXPERIMENTAL

Single- and multiple-dose of 80 mg ALO-02 capsule under 50 mg naltrexone block

Drug: ALO-02Drug: Naltrexone block

40 mg OxyContin tablet

EXPERIMENTAL

Single- and multiple-dose of 40 mg OxyContin tablet under 50 mg naltrexone block

Drug: OxyContinDrug: Naltrexone block

Interventions

ALO-02DRUG

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

40 mg ALO-02 capsule
Naltrexone blockDRUG

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

40 mg ALO-02 capsule
OxyContinDRUG

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

40 mg OxyContin tablet

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.

You may not qualify if:

  • Evidence or history of clinically significant diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

MeSH Terms

Interventions

oxycodone naltrexone combinationOxycodone

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2012

First Posted

March 19, 2012

Study Start

March 1, 2012

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

June 28, 2012

Record last verified: 2012-06

Locations

US(1)