HealthPhase 1NCT04256434
A Bioavailability Study of NALDEBAIN ER Injection and Nalbuphine Injection in Healthy Volunteers.
A Phase 1 study testing Dinalbuphine sebacate and Nalbuphine HCl in people with Health, run by Lumosa Therapeutics Co., Ltd. at 1 site in United States.
Trial summary
This is an open-label, sequential 2 cohort, intramuscular injection study in healthy volunteers. The study will enroll approximately 24 healthy volunteers to examine the safety, pharmacokinetics, and bioavailability after intramuscular injection of NALDEBAIN ER Injection and nalbuphine injection. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Health
- What is being tested?
- Dinalbuphine sebacate and Nalbuphine HCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2020to 29 May 2020
- 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
- Male or female, 18 to 55 years of age inclusive at the time of signing the informed consent form
- Body weight must be above 60 kg.
- Body Mass Index (BMI) 18 to 40 kg/m2
- In good health on the basis of medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.
- If male, must agree to use contraception as detailed in Appendix 5 of this protocol during the treatment period until the final PK sample, and refrain from donating sperm for 90 days after the dosing.
- If female, is not pregnant (see Appendix 5), not breastfeeding, and at least one of the following conditions applies:
Show all 16Show fewer
- Not a woman of childbearing potential (WOCBP) as defined in Appendix 5 OR A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 during the treatment period until the last PK sample.
- Vital signs (after 3 minutes resting in a semi-supine position) which are within the following ranges:
- Oral 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.
- Respiratory rate, 12-20 bpm
- Oxyhemoglobin saturation, ≥95%
- Fasting blood glucose, <110 mg/dL.
- Able to communicate well with the investigator and comply with the requirements of the study.
Who cannot join
- Use of any 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 weeks period).
- Alcohol or caffeine ingested within 72 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.
- Documented history of cardiovascular disease.
Show all 21Show fewer
- Documented history of gastrointestinal disease.
- Documented history of asthma or lung disease.
- Presence of liver disease or liver injury as indicated by an abnormal liver function profile such as aspartate aminotransaminase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (gamma-GT), Alkaline Phosphatase, or Total Bilirubin at Screening. (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 at Screening. (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)
- Documented history of neurological disease.
- Documented history of psychiatric disease.
- Has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV; has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or tests positive for HBsAg or anti-HCV at Screening.
- A known hypersensitivity to nalbuphine or its analogs.
- History of drug or alcohol abuse within 12 months prior to dosing or positive test results for alcohol or drugs of abuse at Screening and admission.
- Permanent confinement to an institution.
- Pregnant or lactating women.
- Subject has received any investigational product within 30 days or 5 half-lives (whichever is longer) prior to the dosing day or is planning to participate in a clinical trial during the study period.
- Has preplanned surgery or procedures that would interfere with the conduct of the study
- Individuals are judged by the investigator to be undesirable subjects for other reasons.
- Is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
This is an open-label, sequential 2 cohort, intramuscular injection study in healthy volunteers. The study will enroll approximately 24 healthy volunteers to examine the safety, pharmacokinetics, and bioavailability after intramuscular injection of NALDEBAIN ER Injection and nalbuphine injection.
Read the detailed description
Each subject in a cohort will be evaluated for study eligibility during the screening period, which is within 28 days prior to receiving the study drug (Day 1). Eligible subjects will be admitted into the study site on Day -1 and will be required to stay in clinical site for 5 (Cohort 1) or 2 nights (Cohort 2) for study procedures in each cohort. Eligible subjects will undergo additional eligibility assessments on Day -1 and those reconfirmed eligible will intramuscularly receive NALDEBAIN ER Injection (Cohort 1) or nalbuphine (Cohort 2) on Day 1.
The blood sampling timepoints for Cohort 1 will be at predose, 6, 12, 24, 48, 56, 64, 72, 80, 88, and 96 hours after dosing. Subjects will be discharged after the 96-hour blood sample and return to the clinical site for the sample collection at 120, 168, 216, 288 and 360 hours post dosing. The blood sampling timepoints for Cohort 2 will be predose, 5, 15, and 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose.
Subjects will return for a follow-up visit to complete safety evaluations for approximately 15 days after study drug administration in cohort 1; and 1 days after study drug administration in Cohort 2.
- Conditions
- Health
- Being tested
- Dinalbuphine sebacate, Nalbuphine HCl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dinalbuphine sebacateDrug
Also called NALDEBAIN ER Injection, Sebacoyl Dinalbuphine Ester Injection, LT1001
150 mg Dinalbuphine sebacate
Nalbuphine HClDrug
Also called Nalbuphine HCl Injection
20 mg Nalbuphine
| Study group | Role | What they receive |
|---|---|---|
| Dinabuphine sebacate | Experimental | Each subject in cohort 1 will receive 150 mg Dinalbuphine sebacate (75 mg/mL x 2 mL) intramuscularly. Receives: Drug: Dinalbuphine sebacate |
| Nalbuphine HCl | Active comparator | Each subject in cohort 2 will receive 20 mg Nalbuphine (20 mg x 1 mL) intramuscularly. Receives: Drug: Nalbuphine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability of nalbuphine after intramuscular injection of NALDEBAIN and Nalbuphine.
To evaluate the relative bioavailability of nalbuphine after intramuscular injection of NALDEBAIN and Nalbuphine.
Measured: Cohort 1: From predose to 360 hours post dosing. Cohort 2 : From predose to 24 hours post dosing.
Secondary outcomes (9)
Maximum plasma concentration (Cmax) of nalbuphine, sebacoyl mononalbuphine ester (SME) and dinalbuphine sebacate.
Cmax for NALDEBAIN and Nalbuphine.
Measured: Cohort 1: From predose to 360 hours post dosing. Cohort 2 : From predose to 24 hours post dosing.
Tmax of nalbuphine, sebacoyl mononalbuphine ester (SME) and dinalbuphine sebacate.
Tmax for NALDEBAIN and Nalbuphine.
Measured: Cohort 1: From predose to 360 hours post dosing. Cohort 2 : From predose to 24 hours post dosing.
AUCinf of nalbuphine, sebacoyl mononalbuphine ester (SME) and dinalbuphine sebacate.
AUCinf for NALDEBAIN and Nalbuphine.
Measured: Cohort 1: From predose to 360 hours post dosing. Cohort 2 : From predose to 24 hours post dosing.
AUClast of nalbuphine, sebacoyl mononalbuphine ester (SME) and dinalbuphine sebacate.
AUClast for NALDEBAIN and Nalbuphine.
Measured: Cohort 1: From predose to 360 hours post dosing. Cohort 2 : From predose to 24 hours post dosing.
Elimination half-life (t1/2) of nalbuphine, sebacoyl mononalbuphine ester (SME) and dinalbuphine sebacate.
Elimination half-life for NALDEBAIN and Nalbuphine.
Measured: Cohort 1: From predose to 360 hours post dosing. Cohort 2 : From predose to 24 hours post dosing.
Total body clearance of the drug from plasma (CL) of nalbuphine, sebacoyl mononalbuphine ester (SME) and dinalbuphine sebacate.
Total body clearance for NALDEBAIN and Nalbuphine.
Measured: Cohort 1: From predose to 360 hours post dosing. Cohort 2 : From predose to 24 hours post dosing.
Volume of distribution (Vd) of nalbuphine, sebacoyl mononalbuphine ester (SME) and dinalbuphine sebacate.
Volume of distribution for NALDEBAIN and Nalbuphine.
Measured: Cohort 1: From predose to 360 hours post dosing. Cohort 2 : From predose to 24 hours post dosing.
Incidence and severity of adverse events (AEs)
To evaluate the systemic and local safety and tolerance.
Measured: Cohort 1: From predose to 360 hours post dosing. Cohort 2 : From predose to 24 hours post dosing.
Number of subjects with AEs
To evaluate number of subjects with adverse events.
Measured: Cohort 1: From predose to 360 hours post dosing. Cohort 2 : From predose to 24 hours post dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start31 Jan 2020
- Primary completion29 May 2020
- Study completion29 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthStudies 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
- Sequential
- Model description
- This is an open-label, sequential 2 cohort, intramuscular injection study in healthy volunteers.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumosa Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Nguyen, MD, Principal investigator, WCCT Global
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256434
- Sponsor's protocol ID
- LT1001-104
- Status last verified
- Nov 2021
- First submitted
- 2 Feb 2020
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioavailability Study of NALDEBAIN ER Injection and Nalbuphine Injection in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT04256434
- Acronym / sponsor ID
- LT1001-104
- Conditions
- Health
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Lumosa Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 29 May 2020 (actual)
- First posted
- 5 Feb 2020 (actual)
- 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 is an open-label, sequential 2 cohort, intramuscular injection study in healthy volunteers. The study will enroll approximately 24 healthy volunteers to examine the safety, pharmacokinetics, and bioavailability after intramuscular injection of NALDEBAIN ER Injection and nalbuphine injection.
Detailed description
Each subject in a cohort will be evaluated for study eligibility during the screening period, which is within 28 days prior to receiving the study drug (Day 1). Eligible subjects will be admitted into the study site on Day -1 and will be required to stay in clinical site for 5 (Cohort 1) or 2 nights (Cohort 2) for study procedures in each cohort. Eligible subjects will undergo additional eligibility assessments on Day -1 and those reconfirmed eligible will intramuscularly receive NALDEBAIN ER Injection (Cohort 1) or nalbuphine (Cohort 2) on Day 1.
The blood sampling timepoints for Cohort 1 will be at predose, 6, 12, 24, 48, 56, 64, 72, 80, 88, and 96 hours after dosing. Subjects will be discharged after the 96-hour blood sample and return to the clinical site for the sample collection at 120, 168, 216, 288 and 360 hours post dosing. The blood sampling timepoints for Cohort 2 will be predose, 5, 15, and 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose.
Subjects will return for a follow-up visit to complete safety evaluations for approximately 15 days after study drug administration in cohort 1; and 1 days after study drug administration in Cohort 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open-label, sequential 2 cohort, intramuscular injection study in healthy volunteers.
| Arm | Type | Receives |
|---|---|---|
| Dinabuphine sebacate | Experimental | Drug: Dinalbuphine sebacateEach subject in cohort 1 will receive 150 mg Dinalbuphine sebacate (75 mg/mL x 2 mL) intramuscularly. |
| Nalbuphine HCl | Active comparator | Drug: Nalbuphine HClEach subject in cohort 2 will receive 20 mg Nalbuphine (20 mg x 1 mL) intramuscularly. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Male or female, 18 to 55 years of age inclusive at the time of signing the informed consent form
- Body weight must be above 60 kg.
- Body Mass Index (BMI) 18 to 40 kg/m2
- In good health on the basis of medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.
- If male, must agree to use contraception as detailed in Appendix 5 of this protocol during the treatment period until the final PK sample, and refrain from donating sperm for 90 days after the dosing.
Key exclusion criteria (21 listed)
- Use of any 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 weeks period).
- Alcohol or caffeine ingested within 72 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 |
|---|---|---|
| Dinalbuphine sebacateAlso: NALDEBAIN ER Injection, Sebacoyl Dinalbuphine Ester Injection, LT1001150 mg Dinalbuphine sebacate | Drug | Dinabuphine sebacate |
| Nalbuphine HClAlso: Nalbuphine HCl Injection20 mg Nalbuphine | Drug | Nalbuphine HCl |
Primary outcome
Bioavailability of nalbuphine after intramuscular injection of NALDEBAIN and Nalbuphine.
Time frame: Cohort 1: From predose to 360 hours post dosing. Cohort 2 : From predose to 24 hours post dosing.
To evaluate the relative bioavailability of nalbuphine after intramuscular injection of NALDEBAIN and Nalbuphine.
9 secondary outcomes
Maximum plasma concentration (Cmax) of nalbuphine, sebacoyl mononalbuphine ester (SME) and dinalbuphine sebacate.
Time frame: Cohort 1: From predose to 360 hours post dosing. Cohort 2 : From predose to 24 hours post dosing.
Tmax of nalbuphine, sebacoyl mononalbuphine ester (SME) and dinalbuphine sebacate.
Time frame: Cohort 1: From predose to 360 hours post dosing. Cohort 2 : From predose to 24 hours post dosing.
AUCinf of nalbuphine, sebacoyl mononalbuphine ester (SME) and dinalbuphine sebacate.
Time frame: Cohort 1: From predose to 360 hours post dosing. Cohort 2 : From predose to 24 hours post dosing.
AUClast of nalbuphine, sebacoyl mononalbuphine ester (SME) and dinalbuphine sebacate.
Time frame: Cohort 1: From predose to 360 hours post dosing. Cohort 2 : From predose to 24 hours post dosing.
Elimination half-life (t1/2) of nalbuphine, sebacoyl mononalbuphine ester (SME) and dinalbuphine sebacate.
Time frame: Cohort 1: From predose to 360 hours post dosing. Cohort 2 : From predose to 24 hours post dosing.
Total body clearance of the drug from plasma (CL) of nalbuphine, sebacoyl mononalbuphine ester (SME) and dinalbuphine sebacate.
Time frame: Cohort 1: From predose to 360 hours post dosing. Cohort 2 : From predose to 24 hours post dosing.
Volume of distribution (Vd) of nalbuphine, sebacoyl mononalbuphine ester (SME) and dinalbuphine sebacate.
Time frame: Cohort 1: From predose to 360 hours post dosing. Cohort 2 : From predose to 24 hours post dosing.
Incidence and severity of adverse events (AEs)
Time frame: Cohort 1: From predose to 360 hours post dosing. Cohort 2 : From predose to 24 hours post dosing.
Number of subjects with AEs
Time frame: Cohort 1: From predose to 360 hours post dosing. Cohort 2 : From predose to 24 hours post dosing.
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 Nov 2021.
Related trials for Health
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
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.
David Nguyen, MD principal investigator
WCCT Global
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 Dinalbuphine sebacate and Nalbuphine HCl in people with Health, run by Lumosa Therapeutics Co., Ltd. at 1 site in United States.
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 16 inclusion and 21 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 Nov 2021. 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 United States. 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?
Bioavailability of nalbuphine after intramuscular injection of NALDEBAIN and Nalbuphine. (time frame: Cohort 1: From predose to 360 hours post dosing. Cohort 2 : From predose to 24 hours post dosing.). 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 Nov 2021.