Pharmacokinetic Profile of OROS Hydromorphone in Healthy Taiwanese Participants With Different Genotypes for the UGT2B7 Gene
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
2 other identifiers
interventional
29
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Oct 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 5, 2011
CompletedFirst Posted
Study publicly available on registry
December 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedMarch 4, 2013
March 1, 2013
3 months
December 5, 2011
March 1, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plasma hydromorphone concentration
20 time points up to 72 hours post-dose
Secondary Outcomes (2)
Plasma hydromorphone 3-glucuronide concentration
20 time points up to 72 hours post-dose
Number of participants with adverse events as a measure of safety and tolerability
Approximately 33 days
Study Arms (1)
Hydromorphone 16 mg
EXPERIMENTALInterventions
type= exact number, unit= mg, number= 16, format= tablet, route= oral use. One tablet of hydromorphone 16 mg.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Taipei, Taiwan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Development, L.L.C. Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2011
First Posted
December 7, 2011
Study Start
October 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
March 4, 2013
Record last verified: 2013-03