Pharmacokinetics Study of ALO-02 and OxyContin

An Open-label, Single-dose and Multiple-dose, Randomized, Crossover Study to Evaluate Pharmacokinetics, Safety and Tolerability After Administration of ALO-02 40 Mg Twice Daily Compared to ALO-02 80 Mg Once Daily and to Oxycontin 40 Mg Twice Daily in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01557257

Enrollment

Registered

2012-03-19

Start date

2012-03-31

Completion date

2012-05-31

Last updated

2012-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Management of Moderate to Severe Pain

Keywords

single- and multiple-dose pharmacokinetics, ALO-02, OxyContin

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

Interventions

DRUGALO-02

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

DRUGNaltrexone 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

DRUGOxyContin

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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
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: 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

Measure	Time frame
Multiple-dose administration: Time to Reach Maximum Observed Plasma Concentration (Tmax) of noroxycodone and oxymorphone, 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 noroxycodone and oxymorphone, 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
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
Multiple-dose administration: Rac of noroxycodone and oxymorphone, 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 Observed Plasma Concentration (Cmax) of noroxycodone and oxymorphone, 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 noroxycodone and oxymorphone, 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
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
Multiple-dose administration: Accumulation ratio (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
Multiple-dose administration: Maximum Observed Plasma Concentration (Cmax) 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 from time zero to 24 hours (AUC24) of noroxycodone and oxymorphone, 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 (AUCτ) of noroxycodone and oxymorphone, 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 (Cmax,ss) of noroxycodone and oxymorphone, 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 (Cmin,ss) of noroxycodone and oxymorphone, 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 (Cave,ss) of noroxycodone and oxymorphone, 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026