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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01487564
Recruitment Status : Completed
First Posted : December 7, 2011
Last Update Posted : March 4, 2013
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Hydromorphone 16 mg Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Hydromorphone 16 mg Drug: Hydromorphone 16 mg
type= exact number, unit= mg, number= 16, format= tablet, route= oral use. One tablet of hydromorphone 16 mg.

Primary Outcome Measures :
  1. Plasma hydromorphone concentration [ Time Frame: 20 time points up to 72 hours post-dose ]

Secondary Outcome Measures :
  1. Plasma hydromorphone 3-glucuronide concentration [ Time Frame: 20 time points up to 72 hours post-dose ]
  2. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Approximately 33 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01487564

Taipei, Taiwan
Sponsors and Collaborators
Janssen Research & Development, LLC
Study Director: Janssen Research & Development, LLC Development, L.L.C. Clinical Trial Janssen Research & Development, LLC

Responsible Party: Janssen Research & Development, LLC Identifier: NCT01487564     History of Changes
Other Study ID Numbers: CR017701
42801PAI1011 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: December 7, 2011    Key Record Dates
Last Update Posted: March 4, 2013
Last Verified: March 2013

Keywords provided by Janssen Research & Development, LLC:
Healthy volunteers
OROS Hydromorphone
UGT2B7 Gene

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents