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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01487564
First received: December 5, 2011
Last updated: March 1, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Healthy Volunteers
Drug: Hydromorphone 16 mg
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Plasma hydromorphone concentration [ Time Frame: 20 time points up to 72 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma hydromorphone 3-glucuronide concentration [ Time Frame: 20 time points up to 72 hours post-dose ] [ Designated as safety issue: No ]
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Approximately 33 days ] [ Designated as safety issue: Yes ]

Enrollment: 29
Study Start Date: October 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01487564

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

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01487564     History of Changes
Other Study ID Numbers: CR017701, 42801PAI1011
Study First Received: December 5, 2011
Last Updated: March 1, 2013
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Hydromorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014