Pharmacokinetic Profile of OROS Hydromorphone in Healthy Taiwanese Participants With Different Genotypes for the UGT2B7 Gene

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to investigate the pharmacokinetics of OROS hydromorphone in healthy adult Taiwanese participants after the oral administration of a single 16 mg dose.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01487512

Healthy Volunteers

COMPLETED PHASE1

A Pharmacokinetic and Safety Study of Osmotic Release Oral System (OROS) Hydromorphone in Non-Opioid Tolerant Chinese Participants With Cancer

NCT01824524

Pain

COMPLETED PHASE1

An Open-label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years for Postoperative Pain

NCT00465647

Postoperative Pain

COMPLETED PHASE4

A Study of the Effectiveness and Safety of Sustained-release Hydromorphone (a Strong Opioid) in Patients With Chronic Noncancer Pain.

NCT00261495

Pain

COMPLETED PHASE3

Study to Evaluate Effectiveness and Tolerability of OROS Hydromorphone for Cancer Pain Treatment in Korean Patients

NCT01621100

Cancer Pain

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a single-center, open-label (all people know the identity of the intervention), single-dose study in healthy adult Taiwanese participants. A minimum of 6 participants identified as having the UGT2B7 \*2/\*2 variant genotype and 12 participants identified as having the UGT2B7 \*1/\*1 wild type genotype will be included in the study. The study will explore the impact of genetic polymorphism in the UGT2B7 gene (occurrence of variants of this gene) on the pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) of OROS hydromorphone. This study consists of a screening phase followed by a 5-day open-label treatment phase. During the screening phase, a blood sample will be collected for a genetic test to confirm the presence of the UGT2B7 gene. During the study period, upon completion of a 12-hour overnight fast, participants will receive a single oral 16-mg dose of OROS hydromorphone in the morning of Day 1. Blood samples will be collected through 72 hours after dosing for the determination of plasma hydromorphone and hydromorphone 3-glucuronide concentrations. The safety and tolerability of 16-mg OROS hydromorphone will also be assessed. The total study duration for each participant is approximately 33 days.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hydromorphone 16 mg

Group Type EXPERIMENTAL

Hydromorphone 16 mg

Intervention Type DRUG

type= exact number, unit= mg, number= 16, format= tablet, route= oral use. One tablet of hydromorphone 16 mg.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hydromorphone 16 mg

type= exact number, unit= mg, number= 16, format= tablet, route= oral use. One tablet of hydromorphone 16 mg.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participation in the DNA analysis to confirm UGT2B7 genotype status
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes