PainPhase 1NCT02446301
A Bioavailability Study of Sebacoyl Dinalbuphine Ester IM Injection in Healthy Volunteers
A Phase 1 study testing Bain® and SDE in people with Pain and Analgesia Disorder, run by Lumosa Therapeutics Co., Ltd. at 1 site in Taiwan.
Trial summary
This study is to evaluate the relative bioavailability of nalbuphine after single IM injection of Sebacoyl Dinalbuphine Ester (SDE) injection and Bain®, Nalbuphine HCl IM injection in healthy volunteers. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Analgesia Disorder
- What is being tested?
- Bain® and SDE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2015to Apr 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be male or female adults in good health on the basis of medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.
- Vital signs (after 3 minutes resting in a upright position) which are within the following ranges:
- Ear body temperature between 35.0-37.5°C. Systolic blood pressure, 90-140 mm Hg. Diastolic blood pressure, 50-90 mm Hg. Pulse rate, 50-90 bpm. Fasting blood glucose, < 110 mg/dL.
- Within -20% to +20% of the ideal body weight. For male subjects, body weight must be above 50 kg and for female subjects, body weight must be above 45 kg.
- Able to sign informed consent prior to study.
- Able to communicate well with the investigator and comply with the requirements of the study.
Who cannot join
- Use of any alcohol-containing products, prescription medications or over-the-counter, non-prescription preparations (including herbal preparations) within 2 weeks prior to study entry unless deemed acceptable by the Investigator (except up to 5 doses of ≤ 1000 mg of acetaminophen or ≤ 400 mg ibuprofen within this 2 week period).
- Alcohol or caffeine ingested within 48 hours prior to dosing.
- Significant illness within 2 weeks prior to dosing.
- Participation in any clinical investigation within 2 months prior to dosing or longer as required by local regulation.
- Donation or loss of more than 500 mL of blood within 3 months prior to dosing. Donation or loss of more than 250 mL of blood within 2 months prior to dosing.
- Presence of cardiovascular disease.
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- Presence of gastrointestinal disease.
- Presence of asthma or lung disease.
- Presence of liver disease or liver injury as indicated by an abnormal liver function profile such as AST, ALT, gamma-GT, Alkaline Phosphatase, or Total Bilirubin. (value of AST or ALT above 3 times of the upper limit of the normal range; other items clinically significant abnormality judged by investigator).
- Presence of impaired renal function as indicated by abnormal creatinine or BUN values or abnormal urinary constituents. (value of creatinine or BUN beyond the range from -20% of the lower limit of the normal range to +20% of the upper limit of the normal range; other items clinically significant abnormality judged by investigator)
- Presence of neurological disease.
- Presence of psychiatric disease.
- Subject is positive for HIV immunology test.
- A known hypersensitivity to nalbuphine or its analogs.
- History of drug or alcohol abuse within 12 months prior to dosing.
- Permanent confinement to an institution.
- Pregnant or lactating women.
- Individuals are judged by the investigator or pharmacokineticist to be undesirable as subjects for other reasons
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei Medical University - Shuang Ho Hospital
New Taipei City, 23561
About this study
Official title: A Bioavailability Study of Sebacoyl Dinalbuphine Ester IM Injection vs. Bain®. Nalbuphine HCl IM Injection, in Healthy Volunteers
This study is to evaluate the relative bioavailability of nalbuphine after single IM injection of Sebacoyl Dinalbuphine Ester (SDE) injection and Bain®, Nalbuphine HCl IM injection in healthy volunteers.
- Conditions
- Pain, Analgesia Disorder
- Being tested
- Bain®, SDE
- Keywords
- Nalbuphine, SDE, dinalbuphine, SDN, pain, LT1001
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bain®Drug
Also called Nalbuphine HCl
Nalbuphine HCl 20mg, IM injection
SDEDrug
Also called Sebacoyl Dinalbuphine Ester Injection, LT1001
Sebacoyl Dinalbuphine Ester 150mg/2ml, IM injection
| Study group | Role | What they receive |
|---|---|---|
| Period I (reference drug) | Experimental | Before administration of investigational products, subjects should be fasted for 10 hours. On the dosing day, subjects will be confined after administration and won't be discharged until after completion of sample collections for 24 hours following dosing in Period I (Bain® IM injection). Receives: Drug: Bain® |
| Period II (Test drug) | Experimental | Subjects will be back to the clinical site to join Period II (SDE IM injection) and will be discharged after completion for sample collections for 24 hours post drug administration. Receives: Drug: SDE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood concentration of Nalbuphine HCl
Protocol-specified pharmacokinetic parameters will be determined from blood samples collected after each administration of study drug to assess the relative bioavailability of SDE.
Measured: Period I: pre-dose (0 h) and 0.083, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose for Bain®, Nalbuphine HCl IM injection ; Period II: pre-dose (0 h) and 6, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post dose for SDE IM injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startJan 2015
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumosa Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02446301
- Sponsor's protocol ID
- LT1001-103
- Status last verified
- May 2015
- First submitted
- 13 May 2015
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioavailability Study of Sebacoyl Dinalbuphine Ester IM Injection vs. Bain®. Nalbuphine HCl IM Injection, in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02446301
- Acronym / sponsor ID
- LT1001-103
- Conditions
- Pain, Analgesia Disorder
- Keywords
- Nalbuphine, SDE, dinalbuphine, SDN, pain, LT1001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lumosa Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 18 May 2015 (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.
This study is to evaluate the relative bioavailability of nalbuphine after single IM injection of Sebacoyl Dinalbuphine Ester (SDE) injection and Bain®, Nalbuphine HCl IM injection in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period I (reference drug) | Experimental | Drug: Bain®Before administration of investigational products, subjects should be fasted for 10 hours. On the dosing day, subjects will be confined after administration and won't be discharged until after completion of sample collections for 24 hours following dosing in Period I (Bain® IM injection). |
| Period II (Test drug) | Experimental | Drug: SDESubjects will be back to the clinical site to join Period II (SDE IM injection) and will be discharged after completion for sample collections for 24 hours post drug administration. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must be male or female adults in good health on the basis of medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.
- Vital signs (after 3 minutes resting in a upright position) which are within the following ranges:
- Ear body temperature between 35.0-37.5°C. Systolic blood pressure, 90-140 mm Hg. Diastolic blood pressure, 50-90 mm Hg. Pulse rate, 50-90 bpm. Fasting blood glucose, < 110 mg/dL.
- Within -20% to +20% of the ideal body weight. For male subjects, body weight must be above 50 kg and for female subjects, body weight must be above 45 kg.
- Able to sign informed consent prior to study.
Key exclusion criteria (18 listed)
- Use of any alcohol-containing products, prescription medications or over-the-counter, non-prescription preparations (including herbal preparations) within 2 weeks prior to study entry unless deemed acceptable by the Investigator (except up to 5 doses of ≤ 1000 mg of acetaminophen or ≤ 400 mg ibuprofen within this 2 week period).
- Alcohol or caffeine ingested within 48 hours prior to dosing.
- Significant illness within 2 weeks prior to dosing.
- Participation in any clinical investigation within 2 months prior to dosing or longer as required by local regulation.
- Donation or loss of more than 500 mL of blood within 3 months prior to dosing. Donation or loss of more than 250 mL of blood within 2 months prior to dosing.
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 |
|---|---|---|
| Bain®Also: Nalbuphine HClNalbuphine HCl 20mg, IM injection | Drug | Period I (reference drug) |
| SDEAlso: Sebacoyl Dinalbuphine Ester Injection, LT1001Sebacoyl Dinalbuphine Ester 150mg/2ml, IM injection | Drug | Period II (Test drug) |
Primary outcome
Blood concentration of Nalbuphine HCl
Time frame: Period I: pre-dose (0 h) and 0.083, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose for Bain®, Nalbuphine HCl IM injection ; Period II: pre-dose (0 h) and 6, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post dose for SDE IM injection
Protocol-specified pharmacokinetic parameters will be determined from blood samples collected after each administration of study drug to assess the relative bioavailability of SDE.
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 19 May 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bain® and SDE in people with Pain and Analgesia Disorder, run by Lumosa Therapeutics Co., Ltd. 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 6 inclusion and 18 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 19 May 2015. 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?
Blood concentration of Nalbuphine HCl (time frame: Period I: pre-dose (0 h) and 0.083, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose for Bain®, Nalbuphine HCl IM injection ; Period II: pre-dose (0 h) and 6, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post dose for SDE IM injection). 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 19 May 2015.