Pharmacokinetic Profile of OROS Hydromorphone in Healthy Taiwanese Participants With Different Genotypes for the UGT2B7 Gene
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: Hydromorphone 16 mg (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
This study is not yet recruiting patients. Please check back for future recruiting sites, or email, Email: JNJ.CT@sylogent.com
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.
Official title: A Single-Dose, Open-Label Study to Evaluate the Pharmacokinetic Profile of OROS Hydromorphone in Healthy Adult Taiwanese Subjects Having Different Genotypes for the UGT2B7 Gene
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Plasma hydromorphone concentration
Plasma hydromorphone 3-glucuronide concentration
Number of participants with adverse events as a measure of safety and tolerability
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.
Minimum age: 18 Years.
Maximum age: 55 Years.
- 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
- 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
- Clinically significant abnormal physical examination, vital signs or 12 lead
- Use of certain prescription or nonprescription medication, and consumption of
products that may interfere with the study
Locations and Contacts
This study is not yet recruiting patients. Please check back for future recruiting sites, or email, Email: JNJ.CT@sylogent.comAdditional Information
Starting date: October 2011
Last updated: December 7, 2011