Effect of Dose on the Pharmacokinetics of OROS Hydromorphone Under Fasted Conditions in Healthy Taiwanese Participants

Phase 1

Completed

• Conditions: Healthy Volunteers

• Registration Number: NCT01487512
• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics of OROS Hydromorphone in healthy adult Taiwanese participants after oral administration of 4 different dose strengths of 8, 16, 32 and 64 mg under fasted conditions.

Detailed Description

This is a single-center, randomized (study drug assigned by chance like flipping a coin), open-label (all people involved know the identity of the intervention), 4-way crossover (participants receive different interventions sequentially during the trial) study in healthy adult Taiwanese participants. All participants will be randomly assigned to 1 of the 4 different possible treatment sequences and will receive all treatments in the order specified by the randomization schedule. The study consists of a screening phase, an open-label treatment phase consisting of 4 single-dose treatment periods, and end-of-study or withdrawal assessments. During the open-label treatment periods, the participants will stay in the center until completion of the 72-hour pharmacokinetics \[PK\] (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) blood sample on Day 4. A 7- to 14-day washout period (period when receiving no treatment) will separate the open-label treatment periods. The safety and tolerability will be evaluated over the investigated dose range. The duration of participation in the study for an individual participant will be approximately 12 weeks.

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Study First Submitted: 2011-12-05
• Study First Submitted QC: 2011-12-06
• Study First Posted: 2011-12-07
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-15
• Last Update Posted: 2012-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Body mass index (BMI) between 18 and 25 kg/m², inclusive and a body weight of not less than 50 kg - Participants must utilize a medically acceptable method of contraception throughout the entire study period and for 1 month after the study is completed - Each participant will receive a naloxone challenge test for opioid dependency at screening. Only those participants who pass this challenge test will be allowed to continue in the study

Exclusion Criteria

• History of or current clinically medical illness or any other condition that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results - Clinically significant abnormal values for hematology, clinical chemistry or urinalysis - Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram (ECG) - Use of certain prescription or nonprescription medication, and consumption of products that may interfere with the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Plasma hydromorphone concentrations	20 time points up to 72 hours post-dose	Sequential blood samples are collected over 72 hours during each treatment period. The study has a total of four 5-day treatment periods. The treatment periods are separated by a 7- to 14-day washout period.

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events as a measure of safety and tolerability	Approximately 12 weeks