Healthy VolunteersPhase 1NCT01487564
Pharmacokinetic Profile of OROS Hydromorphone in Healthy Taiwanese Participants With Different Genotypes for the UGT2B7 Gene
A Phase 1 study testing Hydromorphone 16 mg in people with Healthy Volunteers, run by Janssen Research & Development, LLC at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Hydromorphone 16 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2011to Jan 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Hydromorphone 16 mg
- Keywords
- Healthy volunteers, Pharmacokinetics, OROS Hydromorphone, Hydromorphone, Taiwan, UGT2B7 Gene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydromorphone 16 mgDrug
type= exact number, unit= mg, number= 16, format= tablet, route= oral use. One tablet of hydromorphone 16 mg.
| Study group | Role | What they receive |
|---|---|---|
| Hydromorphone 16 mg | Experimental | Not described Receives: Drug: Hydromorphone 16 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma hydromorphone concentration
Measured: 20 time points up to 72 hours post-dose
Secondary outcomes (2)
Plasma hydromorphone 3-glucuronide concentration
Measured: 20 time points up to 72 hours post-dose
Number of participants with adverse events as a measure of safety and tolerability
Measured: Approximately 33 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Development, L.L.C. Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487564
- Sponsor's protocol ID
- CR017701
- Other IDs
- 42801PAI1011
- Status last verified
- Mar 2013
- First submitted
- 5 Dec 2011
- Last updated
- 4 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01487564
- Acronym / sponsor ID
- CR017701
- Conditions
- Healthy Volunteers
- Keywords
- Healthy volunteers, Pharmacokinetics, OROS Hydromorphone, Hydromorphone, Taiwan, UGT2B7 Gene
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 7 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydromorphone 16 mg | Experimental | Drug: Hydromorphone 16 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydromorphone 16 mgtype= exact number, unit= mg, number= 16, format= tablet, route= oral use. One tablet of hydromorphone 16 mg. | Drug | Hydromorphone 16 mg |
Primary outcome
Plasma hydromorphone concentration
Time frame: 20 time points up to 72 hours post-dose
2 secondary outcomes
Plasma hydromorphone 3-glucuronide concentration
Time frame: 20 time points up to 72 hours post-dose
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Approximately 33 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Development, L.L.C. Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hydromorphone 16 mg in people with Healthy Volunteers, run by Janssen Research & Development, LLC at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma hydromorphone concentration (time frame: 20 time points up to 72 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2013.