Pharmacokinetics Study of ALO-02 and OxyContin

Condition(s) targeted: Management of Moderate to Severe Pain

Intervention: ALO-02 (Drug); Naltrexone block (Drug); ALO-02 (Drug); Naltrexone block (Drug); OxyContin (Drug); Naltrexone block (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

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

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

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

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

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.

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

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

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

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

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

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

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

Secondary outcome:

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

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.

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

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

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

Multiple-dose administration: Accumulation ratio (Rac) of oxycodone, as data permit

Multiple-dose administration: Maximum Observed Plasma Concentration (Cmax) of oxycodone, as data permit

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.

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.

Multiple-dose administration: Maximum plasma concentration at steady state (Cmax,ss) of noroxycodone and oxymorphone, as data permit.

Multiple-dose administration: Minimum plasma concentration at steady state (Cmin,ss) of noroxycodone and oxymorphone, as data permit.

Multiple-dose administration: Average plasma concentration at steady state (Cave,ss) of noroxycodone and oxymorphone, as data permit.

Multiple-dose administration: Time to Reach Maximum Observed Plasma Concentration (Tmax) of noroxycodone and oxymorphone, as data permit.

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

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

Multiple-dose administration: Rac of noroxycodone and oxymorphone, as data permit.

Multiple-dose administration: Maximum Observed Plasma Concentration (Cmax) of noroxycodone and oxymorphone, as data permit.

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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.

Pfizer Investigational Site, New Haven, Connecticut 06511, United States

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

Starting date: March 2012
Last updated: June 26, 2012