Healthy VolunteersPhase 1NCT01487512
Effect of Dose on the Pharmacokinetics of OROS Hydromorphone Under Fasted Conditions in Healthy Taiwanese Participants
A Phase 1 study testing Treatment A: Hydromorphone 8 mg, Treatment B: Hydromorphone 16 mg and Treatment C: Hydromorphone 32 mg in people with Healthy Volunteers, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 1 site in Taiwan.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics of OROS Hydromorphone in healthy adult Taiwanese participants after oral administration of 4 different dose strengths of 8, 16, 32 and 64 mg under fasted conditions. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Treatment A: Hydromorphone 8 mg, Treatment B: Hydromorphone 16 mg and Treatment C: Hydromorphone 32 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
- Mar 2011to Jul 2011
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion Criteria: - 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose, Open-Label, Randomized, Crossover Dose Proportionality Study to Evaluate the Effect of Dose on the Pharmacokinetics of 8, 16, 32 and 64 mg OROS Hydromorphone Under Fasted Conditions in Healthy Adult Taiwanese Subjects
The purpose of this study is to evaluate the pharmacokinetics of OROS Hydromorphone in healthy adult Taiwanese participants after oral administration of 4 different dose strengths of 8, 16, 32 and 64 mg under fasted conditions.
Read the detailed description
This is a single-center, randomized (study drug assigned by chance like flipping a coin), open-label (all people involved know the identity of the intervention), 4-way crossover (participants receive different interventions sequentially during the trial) study in healthy adult Taiwanese participants. All participants will be randomly assigned to 1 of the 4 different possible treatment sequences and will receive all treatments in the order specified by the randomization schedule. The study consists of a screening phase, an open-label treatment phase consisting of 4 single-dose treatment periods, and end-of-study or withdrawal assessments. During the open-label treatment periods, the participants will stay in the center until completion of the 72-hour pharmacokinetics [PK] (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) blood sample on Day 4. A 7- to 14-day washout period (period when receiving no treatment) will separate the open-label treatment periods. The safety and tolerability will be evaluated over the investigated dose range. The duration of participation in the study for an individual participant will be approximately 12 weeks.
- Conditions
- Healthy Volunteers
- Being tested
- Treatment A: Hydromorphone 8 mg, Treatment B: Hydromorphone 16 mg, Treatment C: Hydromorphone 32 mg, Treatment D: Hydromorphone 64 mg
- Keywords
- Healthy Volunteers, Dose Proportionality, Pharmacokinetics, OROS Hydromorphone, Hydromorphone, Taiwan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment A: Hydromorphone 8 mgDrug
type= exact number, unit= mg, number= 8, form= tablet, route= oral use. One tablet of Hydromorphone 8 mg in each of 4 treatment sequences.
Treatment B: Hydromorphone 16 mgDrug
type= exact number, unit= mg, number= 16, form= tablet, route= oral use. One tablet of Hydromorphone 16 mg in each of 4 treatment sequences.
Treatment C: Hydromorphone 32 mgDrug
type= exact number, unit= mg, number= 32, form= tablet, route= oral use. One tablet of Hydromorphone 32 mg in each of 4 treatment sequences.
Treatment D: Hydromorphone 64 mgDrug
type= exact number, unit= mg, number= 64, form= tablet, route= oral use. One tablet of Hydromorphone 64 mg in each of 4 treatment sequences.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: Treatment A-D-B-C | Experimental | The study consists of 4 single-dose treatment periods. Successive drug administrations will be separated by a washout period of at least 7 and no more than 14 days. Receives: Drug: Treatment A: Hydromorphone 8 mg; Drug: Treatment B: Hydromorphone 16 mg; Drug: Treatment C: Hydromorphone 32 mg; Drug: Treatment D: Hydromorphone 64 mg |
| Sequence 2: Treatment B-A-C-D | Experimental | The study consists of 4 single-dose treatment periods. Successive drug administrations will be separated by a washout period of at least 7 and no more than 14 days. Receives: Drug: Treatment A: Hydromorphone 8 mg; Drug: Treatment B: Hydromorphone 16 mg; Drug: Treatment C: Hydromorphone 32 mg; Drug: Treatment D: Hydromorphone 64 mg |
| Sequence 3: Treatment C-B-D-A | Experimental | The study consists of 4 single-dose treatment periods. Successive drug administrations will be separated by a washout period of at least 7 and no more than 14 days. Receives: Drug: Treatment A: Hydromorphone 8 mg; Drug: Treatment B: Hydromorphone 16 mg; Drug: Treatment C: Hydromorphone 32 mg; Drug: Treatment D: Hydromorphone 64 mg |
| Sequence 4: Treatment D-C-A-B | Experimental | The study consists of 4 single-dose treatment periods. Successive drug administrations will be separated by a washout period of at least 7 and no more than 14 days. Receives: Drug: Treatment A: Hydromorphone 8 mg; Drug: Treatment B: Hydromorphone 16 mg; Drug: Treatment C: Hydromorphone 32 mg; Drug: Treatment D: Hydromorphone 64 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma hydromorphone concentrations
Sequential blood samples are collected over 72 hours during each treatment period. The study has a total of four 5-day treatment periods. The treatment periods are separated by a 7- to 14-day washout period.
Measured: 20 time points up to 72 hours post-dose
Secondary outcomes (1)
Number of participants with adverse events as a measure of safety and tolerability
Measured: Approximately 12 weeks
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 startMar 2011
- Primary completionJul 2011
- Study completionJul 2011
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.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487512
- Sponsor's protocol ID
- CR017692
- Other IDs
- 42801PAI1010
- Status last verified
- Nov 2012
- First submitted
- 5 Dec 2011
- Last updated
- 16 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Open-Label, Randomized, Crossover Dose Proportionality Study to Evaluate the Effect of Dose on the Pharmacokinetics of 8, 16, 32 and 64 mg OROS Hydromorphone Under Fasted Conditions in Healthy Adult Taiwanese Subjects
- ClinicalTrials.gov ID
- NCT01487512
- Acronym / sponsor ID
- CR017692
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers, Dose Proportionality, Pharmacokinetics, OROS Hydromorphone, Hydromorphone, Taiwan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (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 evaluate the pharmacokinetics of OROS Hydromorphone in healthy adult Taiwanese participants after oral administration of 4 different dose strengths of 8, 16, 32 and 64 mg under fasted conditions.
Detailed description
This is a single-center, randomized (study drug assigned by chance like flipping a coin), open-label (all people involved know the identity of the intervention), 4-way crossover (participants receive different interventions sequentially during the trial) study in healthy adult Taiwanese participants. All participants will be randomly assigned to 1 of the 4 different possible treatment sequences and will receive all treatments in the order specified by the randomization schedule. The study consists of a screening phase, an open-label treatment phase consisting of 4 single-dose treatment periods, and end-of-study or withdrawal assessments. During the open-label treatment periods, the participants will stay in the center until completion of the 72-hour pharmacokinetics [PK] (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) blood sample on Day 4. A 7- to 14-day washout period (period when receiving no treatment) will separate the open-label treatment periods. The safety and tolerability will be evaluated over the investigated dose range. The duration of participation in the study for an individual participant will be approximately 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: Treatment A-D-B-C | Experimental | Drug: Treatment A: Hydromorphone 8 mg, Drug: Treatment B: Hydromorphone 16 mg, Drug: Treatment C: Hydromorphone 32 mg, Drug: Treatment D: Hydromorphone 64 mgThe study consists of 4 single-dose treatment periods. Successive drug administrations will be separated by a washout period of at least 7 and no more than 14 days. |
| Sequence 2: Treatment B-A-C-D | Experimental | Drug: Treatment A: Hydromorphone 8 mg, Drug: Treatment B: Hydromorphone 16 mg, Drug: Treatment C: Hydromorphone 32 mg, Drug: Treatment D: Hydromorphone 64 mgThe study consists of 4 single-dose treatment periods. Successive drug administrations will be separated by a washout period of at least 7 and no more than 14 days. |
| Sequence 3: Treatment C-B-D-A | Experimental | Drug: Treatment A: Hydromorphone 8 mg, Drug: Treatment B: Hydromorphone 16 mg, Drug: Treatment C: Hydromorphone 32 mg, Drug: Treatment D: Hydromorphone 64 mgThe study consists of 4 single-dose treatment periods. Successive drug administrations will be separated by a washout period of at least 7 and no more than 14 days. |
| Sequence 4: Treatment D-C-A-B | Experimental | Drug: Treatment A: Hydromorphone 8 mg, Drug: Treatment B: Hydromorphone 16 mg, Drug: Treatment C: Hydromorphone 32 mg, Drug: Treatment D: Hydromorphone 64 mgThe study consists of 4 single-dose treatment periods. Successive drug administrations will be separated by a washout period of at least 7 and no more than 14 days. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Treatment A: Hydromorphone 8 mgtype= exact number, unit= mg, number= 8, form= tablet, route= oral use. One tablet of Hydromorphone 8 mg in each of 4 treatment sequences. | Drug | Sequence 1: Treatment A-D-B-C, Sequence 2: Treatment B-A-C-D, Sequence 3: Treatment C-B-D-A, Sequence 4: Treatment D-C-A-B |
| Treatment B: Hydromorphone 16 mgtype= exact number, unit= mg, number= 16, form= tablet, route= oral use. One tablet of Hydromorphone 16 mg in each of 4 treatment sequences. | Drug | Sequence 1: Treatment A-D-B-C, Sequence 2: Treatment B-A-C-D, Sequence 3: Treatment C-B-D-A, Sequence 4: Treatment D-C-A-B |
| Treatment C: Hydromorphone 32 mgtype= exact number, unit= mg, number= 32, form= tablet, route= oral use. One tablet of Hydromorphone 32 mg in each of 4 treatment sequences. | Drug | Sequence 1: Treatment A-D-B-C, Sequence 2: Treatment B-A-C-D, Sequence 3: Treatment C-B-D-A, Sequence 4: Treatment D-C-A-B |
| Treatment D: Hydromorphone 64 mgtype= exact number, unit= mg, number= 64, form= tablet, route= oral use. One tablet of Hydromorphone 64 mg in each of 4 treatment sequences. | Drug | Sequence 1: Treatment A-D-B-C, Sequence 2: Treatment B-A-C-D, Sequence 3: Treatment C-B-D-A, Sequence 4: Treatment D-C-A-B |
Primary outcome
Plasma hydromorphone concentrations
Time frame: 20 time points up to 72 hours post-dose
Sequential blood samples are collected over 72 hours during each treatment period. The study has a total of four 5-day treatment periods. The treatment periods are separated by a 7- to 14-day washout period.
1 secondary outcome
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Approximately 12 weeks
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 16 Nov 2012.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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 Treatment A: Hydromorphone 8 mg, Treatment B: Hydromorphone 16 mg and Treatment C: Hydromorphone 32 mg in people with Healthy Volunteers, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 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?
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 16 Nov 2012. 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 concentrations (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 16 Nov 2012.