Improvement of Pruritus in Hemodialysis PatientsPhase 1NCT04420234
A Pharmacokinetics and Safety Study of Narfurine Hydrochloride Orally Disintegrating Tablets
A Phase 1 study testing narfurine hydrochloride orally disintegrating tablets in people with Improvement of Pruritus in Hemodialysis Patients, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
Main objective: To evaluate the pharmacokinetics of single and multiple oral administration of narfurine hydrochloride orally disintegrating tablets in Chinese healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Improvement of Pruritus in Hemodialysis Patients
- What is being tested?
- narfurine hydrochloride orally disintegrating tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 9 Jun 2020to Dec 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 years old <= age <= 40 years old, male or female;
- Weight: male >= 50 kg, female >= 45 kg; body mass index (BMI) in the range of 19-26 kg / m2 (including 19 and 26);
- Important indicators including physical examination, vital signs examination, electrocardiogram examination, laboratory examination, and chest X-ray examination are normal or within the acceptable range of the sponsors or researchers;
- During the trial and within 3 months after the last medication, there is no parenting plan and reliable contraceptive measures could be taken;
- Fully understand the purpose and requirements of this trial, voluntarily participate in clinical trials and sign a written informed consent form, and can complete the entire trial process according to the trial requirements.
Who cannot join
- Those who are known to have a history of allergies, allergic diseases or allergies to the test preparation and any of its components or related preparations;
- Those who have a clear medical history of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders or serious infections and serious injuries, or other diseases that are not suitable for participating in clinical trials (such as history of mental illness, etc.)
- Those who have donated blood or lost blood >= 400mL within 3 months before enrollment;
- Those who have taken any drugs (including prescription drugs and over-the-counter drugs), vitamins, and Chinese herbal medicines within 2 weeks before screening;
- Those who have participated in clinical trials of other drugs or medical devices within 3 months before being selected;
- Those who is or was a drug addict or positive in drug abuse screening test;
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- Those who is or was an alcoholic (drinking more than 14 standard units per week. 1 standard unit contains 14g alcohol, such as 360mL beer or 45mL spirits with 40% alcohol or 150mL wine), or positive in urine alcohol test.
- Smokers or those with an average daily smoking volume of more than 5 cigarettes within 3 months before screening, and those with a positive nicotine test;
- Those who is positive in Hepatitis B surface antigen (HBsAg), HCV antibody, Treponema pallidum antibody and HIV antibody;
- Female subjects who are in the lactation period or is positive in the pregnancy test during the screening period or clinical trial;
- Those who have used any drugs that is CYP3A4 inhibitor or inducer within 4 weeks before signing the informed consent form, see Appendix 3 for details;
- People with long-term insomnia and those with the habit of taking sleeping pills;
- People with habitual constipation;
- Those who is diagnosed abnormal or with clinical significance in physical examination, vital signs examination, electrocardiogram or clinical laboratory examination, etc.,
- Those who have undergone surgery that can affect the absorption, distribution, metabolism, excretion of drugs, or have any gastrointestinal diseases that may affect the absorption of drugs, or those who are determined by the investigator to be unsuitable for enrollment;
- Those who consume excessive amounts of tea, coffee and / or caffeinated beverages (more than 8 cups, 1 cup = 250mL) every day within 30 days before screening
- Those who took grapefruit or grapefruit juice and drinks or foods containing St. John's wort (hypericum perforatum), ginseng, ginkgo, valerian, and echinacea within 48 hours before administration;
- Those who is diagnosed abnormal or have clinical significance by researchers in the chest X-ray examination;
- Those who develop new diseases during the pre-study screening stage or before study medication;
- Those who cannot tolerate venipuncture blood collection;
- Those who are thought to be unsuitable for participating in the trial by the researchers because of other factors.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital,ZheJiang Univercity
Hanzhou, Zhejiang, 310000
About this study
Official title: A Single-center Phase I Clinical Study Evaluating the Pharmacokinetics and Safety of Single and Multiple Oral Administration of Narfurine Hydrochloride Orally Disintegrating Tablets in Chinese Healthy Adult Subjects
Main objective: To evaluate the pharmacokinetics of single and multiple oral administration of narfurine hydrochloride orally disintegrating tablets in Chinese healthy adult subjects.
Secondary objective: To evaluate the safety profile of single and multiple oral administration of narfurine hydrochloride orally disintegrating tablets in Chinese healthy adult subjects.
- Being tested
- narfurine hydrochloride orally disintegrating tablets
- Keywords
- narfurine hydrochloride orally disintegrating tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
narfurine hydrochloride orally disintegrating tabletsDrug
Subjects swallowed 2 tablets of test drug (2.5 µg/tablet) with saliva at about 8:00 AM on D1; swallowed 2 tablets of test drug (2.5 µg/tablet) with saliva at about 8:00 AM starting on D4. Dosing for 7 consecutive days (D10 last dose in the morning).
| Study group | Role | What they receive |
|---|---|---|
| Pharmacokinetics study of single and multiple administration | Experimental | During the study session, 30 healthy subjects will be administered a single and multiple dose of narfurine hydrochloride orally disintegrating tablets 5 µg (2.5 µg/table) to evaluate the pharmacokinetic parameters and the safety profile. Receives: Drug: narfurine hydrochloride orally disintegrating tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC AUC
Area Under the Plasma Concentration-time Curve
Measured: Day1 to Day13
Cmax
Maximum Observed Plasma Concentration
Measured: Day1 to Day13
Tmax
Time to Reach the Maximum Plasma Concentration
Measured: Day1 to Day13
t1/2
Elimination half-life
Measured: Day1 to Day13
Kel
Elimination rate constant
Measured: Day1 to Day13
CL/F CL/F
Apparent clearance
Measured: Day1 to Day13
Vd/F
Apparent distribution volume based on terminal elimination phase
Measured: Day1 to Day13
MRT
Mean residence time
Measured: Day1 to Day13
Css_max
Steady state peak concentration
Measured: Day1 to Day13
Css_min
Steady state Valley concentration
Measured: Day1 to Day13
Css_av
Steady state average concentration
Measured: Day1 to Day13
DF
Volatility index
Measured: Day1 to Day13
Safety and tolerance indicators
AE and SAE
Measured: Day1 to Day13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start9 Jun 2020
- Primary completion28 Jul 2020
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improvement of Pruritus in Hemodialysis PatientsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Responsible party
- Sponsor
- Investigators
- jian liu, master, Principal investigator, The First Affiliated Hospital,ZheJiang Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420234
- Sponsor's protocol ID
- SYSS-Remitch-HD-I-01
- Status last verified
- Jun 2020
- First submitted
- 4 Jun 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Phase I Clinical Study Evaluating the Pharmacokinetics and Safety of Single and Multiple Oral Administration of Narfurine Hydrochloride Orally Disintegrating Tablets in Chinese Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04420234
- Acronym / sponsor ID
- SYSS-Remitch-HD-I-01
- Keywords
- narfurine hydrochloride orally disintegrating tablets
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 28 Jul 2020 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 9 Jun 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.
Main objective: To evaluate the pharmacokinetics of single and multiple oral administration of narfurine hydrochloride orally disintegrating tablets in Chinese healthy adult subjects.
Secondary objective: To evaluate the safety profile of single and multiple oral administration of narfurine hydrochloride orally disintegrating tablets in Chinese healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacokinetics study of single and multiple administration | Experimental | Drug: narfurine hydrochloride orally disintegrating tabletsDuring the study session, 30 healthy subjects will be administered a single and multiple dose of narfurine hydrochloride orally disintegrating tablets 5 µg (2.5 µg/table) to evaluate the pharmacokinetic parameters and the safety profile. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18 years old <= age <= 40 years old, male or female;
- Weight: male >= 50 kg, female >= 45 kg; body mass index (BMI) in the range of 19-26 kg / m2 (including 19 and 26);
- Important indicators including physical examination, vital signs examination, electrocardiogram examination, laboratory examination, and chest X-ray examination are normal or within the acceptable range of the sponsors or researchers;
- During the trial and within 3 months after the last medication, there is no parenting plan and reliable contraceptive measures could be taken;
- Fully understand the purpose and requirements of this trial, voluntarily participate in clinical trials and sign a written informed consent form, and can complete the entire trial process according to the trial requirements.
Key exclusion criteria (21 listed)
- Those who are known to have a history of allergies, allergic diseases or allergies to the test preparation and any of its components or related preparations;
- Those who have a clear medical history of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders or serious infections and serious injuries, or other diseases that are not suitable for participating in clinical trials (such as history of mental illness, etc.)
- Those who have donated blood or lost blood >= 400mL within 3 months before enrollment;
- Those who have taken any drugs (including prescription drugs and over-the-counter drugs), vitamins, and Chinese herbal medicines within 2 weeks before screening;
- Those who have participated in clinical trials of other drugs or medical devices within 3 months before being selected;
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 |
|---|---|---|
| narfurine hydrochloride orally disintegrating tabletsSubjects swallowed 2 tablets of test drug (2.5 µg/tablet) with saliva at about 8:00 AM on D1; swallowed 2 tablets of test drug (2.5 µg/tablet) with saliva at about 8:00 AM starting on D4. Dosing for 7 consecutive days (D10 last dose in the morning). | Drug | Pharmacokinetics study of single and multiple administration |
Primary outcome
AUC AUC
Time frame: Day1 to Day13
Area Under the Plasma Concentration-time Curve
Cmax
Time frame: Day1 to Day13
Maximum Observed Plasma Concentration
Tmax
Time frame: Day1 to Day13
Time to Reach the Maximum Plasma Concentration
t1/2
Time frame: Day1 to Day13
Elimination half-life
Kel
Time frame: Day1 to Day13
Elimination rate constant
CL/F CL/F
Time frame: Day1 to Day13
Apparent clearance
Vd/F
Time frame: Day1 to Day13
Apparent distribution volume based on terminal elimination phase
MRT
Time frame: Day1 to Day13
Mean residence time
Css_max
Time frame: Day1 to Day13
Steady state peak concentration
Css_min
Time frame: Day1 to Day13
Steady state Valley concentration
Css_av
Time frame: Day1 to Day13
Steady state average concentration
DF
Time frame: Day1 to Day13
Volatility index
Safety and tolerance indicators
Time frame: Day1 to Day13
AE and SAE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: No
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.
jian liu, master principal investigator
The First Affiliated Hospital,ZheJiang Univercity
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 narfurine hydrochloride orally disintegrating tablets in people with Improvement of Pruritus in Hemodialysis Patients, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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 5 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: status not confirmed, as of the sponsor's last update on 9 Sep 2020. 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 China. 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?
Results are not available in the source record.
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?
AUC AUC (time frame: Day1 to Day13). The study lists 13 primary outcomes in all. 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 9 Sep 2020.