PHN - Post-Herpetic NeuritisPhase 1NCT05881811
The Drug-drug Interaction of HSK16149 Capsule With Probenecid Tablets or Cimetidine Tablets in Healthy Subjects
A Phase 1 study testing HSK16149，probenecid, cimetidine in people with PHN - Post-Herpetic Neuritis, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This study is a single-center, open-label, crossover study, conducted in healthy Chinese populations, and plans to enroll 48 healthy adult subjects (male and female). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- PHN - Post-Herpetic Neuritis
- What is being tested?
- HSK16149，probenecid, cimetidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2023to 5 Jun 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions;
- 18 years to 50 years (inclusive), male and female;
- Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Body mass index (BMI) : 18-28 kg/m2 (inclusive);
- Physical examination, vital sign measurements results were deemed appropriate by the investigator;
- Not in use of any drug within 2 weeks prior to screening;
- 7. Subjects (including partners) are willing to voluntarily use effective contraceptives from screening to at least 6 months after the last dose administration.
Who cannot join
- Have an allergic history to the main ingredients and/or any auxiliary materials in the research preparation, allergic diseases or allergies, or allergic history to pregabalin or gabapentin, or allergic history to pregabalin or gabapentin or sulfonamides;
- Have special requirements for diet and cannot follow the unified diet;
- The abnormal results of 12-lead electrocardiogram (ECG), chest X-ray (positive position) and routine laboratory tests (blood routine, blood biochemistry, urine routine and coagulation function) during the screening period have clinical significance and are judged by the researchers to be unsuitable to participate in this experiment;
- In the screening period, male QTcF>450 milliseconds (msec) and female QTcF>470 milliseconds (msec);
- dizziness or vertigo with clinical significance and requiring medical intervention, or history of inner ear diseases known to cause dizziness or vertigo;
- Insomnia, anxiety disorder, depression disorder or other mental disorders requiring medical intervention;
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- Use any caffeinated food or drink (coffee, tea, cola, chocolate, etc.) within 48 hours before the first administration of the experimental drug, or disagree with the prohibition of using any caffeinated food or drink during the trial；
- Suffering from or having suffered from major diseases of cardiovascular system, respiratory system, digestive system, urinary system, hematology, endocrine system, immunity system, skin system or nervous system, including acute diseases or major surgical operations within 3 months before screening；
- Suffering from or having suffered from diseases of gastrointestinal tract, liver, kidney or other known diseases that interfere with drug absorption, distribution, metabolism or excretion;
- Blood donation or blood loss of ≥400 mL or more within 3 months before the first administration of the experimental drug;
- Any drugs that inhibit or induce liver drug metabolizing enzymes have been used within 28 days before the first administration of experimental drugs (such as barbiturates, carbamazepine, phenytoin, glucocorticoid and omeprazole; Inhibitor serotonin reuptake inhibitor (SSRI) antidepressants, cimetidine, diltiazem macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines), or any prescription drugs, over-the-counter drugs, Chinese patent medicines and herbs other than the above drugs were taken orally within 14 days before the administration of the experimental drugs;
- have participated in clinical trials of other drugs within 3 months before the first administration of experimental drugs;
- Use any live vaccine within 28 days before the first administration of experimental drugs;
- At present, they are or have been drug users, or they are positive in drug abuse screening (screening items include: morphine, tetrahydrocannabinol, methamphetamine, methylenedioxyamphetamine, ketamine and cocaine);
- Regular drinkers within 3 months before the first administration of the experimental drug, that is, those who drink more than 14 units of alcohol per week (1 unit =10g pure alcohol, or 285mL beer [4.9% Alc./Vol] or 30 mL spirits [40% Alc./Vol] or 100 mL wine [12% Alc./Vol]), or the alcohol breath test is positive；
- Smoking more than 5 cigarettes per day (or using a considerable amount of nicotine-containing products) within 3 months before the first administration of experimental drugs, or failing to comply with the smoking ban during the trial;
- One or more of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, syphilis antibody or human immunodeficiency virus (HIV) antibody are positive during the screening period;
- Have any history of malignant tumor in recent 10 years;
- pregnant or lactating women;
- The estimated glomerular filtration rate (eGFR) during the screening period is clinically significant or has a history of kidney calculi's disease and kidney disease;
- Subjects with poor compliance or other factors that are not suitable for participating in this experiment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Phase I Study to Evaluate the Drug-drug Interaction of HSK16149 Capsule With Probenecid Tablets or Cimetidine Tablets in Healthy Subjects
This study is a single-center, open-label, crossover study, conducted in healthy Chinese populations, and plans to enroll 48 healthy adult subjects (male and female).
- Conditions
- PHN - Post-Herpetic Neuritis
- Being tested
- HSK16149，probenecid, cimetidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK16149，probenecid, cimetidineDrug
40mg HSK16149 single dose, fasted; 500mg probenecid QID from D1~D4 200mg cimetidine QID from D1~D4
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | Period 1: HSK16149 single dose on D1, 40mg, fasted; Period 2: HSK16149 single dose on D2, 40mg, fasted; Probenecid QID (500mg) on D1~D4. HSK16149 would be administered 2 hours after the first dose of probenecid on D2. Receives: Drug: HSK16149，probenecid, cimetidine |
| A2 | Experimental | Period 1: HSK16149 single dose on D2, 40mg, fasted；probenecid QID (500mg) on D1~D4. HSK16149 would be administered 2 hours after the first dose of Probenecid on D2.
Period 2: HSK16149 single dose on D1, 40mg, fasted; Receives: Drug: HSK16149，probenecid, cimetidine |
| B1 | Experimental | Period 1: HSK16149 single dose on D1, 40mg, fasted; Period 2: HSK16149 single dose on D2, 40mg, fasted; Cimetidine QID (200mg) on D1~D4. HSK16149 would be administered 1 hour after the first dose of Cimetidine on D2. Receives: Drug: HSK16149，probenecid, cimetidine |
| B2 | Experimental | Period 1: HSK16149 single dose on D2, 40mg, fasted; Cimetidine QID (200mg) on D1~D4. HSK16149 would be administered 1 hour after the first dose of Cimetidine on D2.
Period 2: HSK16149 single dose on D1, 40mg, fasted; Receives: Drug: HSK16149，probenecid, cimetidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
The maximun plasma concentration of HSK16149
Measured: From the start to 72 hours after administration
AUC0-t
Area under the concentration-time curve from time zero to time of last quantifiable concentration
Measured: From the start to 72 hours after administration
AUC0-inf
Area under the concentration-time curve from time zero extrapolated to infinite time
Measured: From the start to 72 hours after administration
Secondary outcomes (7)
Tmax
Time of maximum concentration
Measured: From the start to 72 hours after administration
t1/2
half life
Measured: From the start to 72 hours after administration
Vz
Volume of distribution associated with the terminal phase
Measured: From the start to 72 hours after administration
CL
Plasma clearance
Measured: From the start to 72 hours after administration
Ae
Cumulative urinary recovery of unchanged drug
Measured: From the start to 72 hours after administration
Fe
Cumulative urinary recovery fraction of unchanged drug
Measured: From the start to 72 hours after administration
CLr
Renal clearance
Measured: From the start to 72 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start20 Mar 2023
- Primary completion24 Apr 2023
- Study completion5 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PHN - Post-Herpetic NeuritisStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881811
- Sponsor's protocol ID
- HSK16149-105
- Status last verified
- Dec 2023
- First submitted
- 16 May 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase I Study to Evaluate the Drug-drug Interaction of HSK16149 Capsule With Probenecid Tablets or Cimetidine Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05881811
- Acronym / sponsor ID
- HSK16149-105
- Conditions
- PHN - Post-Herpetic Neuritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 31 May 2023 (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 study is a single-center, open-label, crossover study, conducted in healthy Chinese populations, and plans to enroll 48 healthy adult subjects (male and female).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Drug: HSK16149，probenecid, cimetidinePeriod 1: HSK16149 single dose on D1, 40mg, fasted; Period 2: HSK16149 single dose on D2, 40mg, fasted; Probenecid QID (500mg) on D1~D4. HSK16149 would be administered 2 hours after the first dose of probenecid on D2. |
| A2 | Experimental | Drug: HSK16149，probenecid, cimetidinePeriod 1: HSK16149 single dose on D2, 40mg, fasted；probenecid QID (500mg) on D1~D4. HSK16149 would be administered 2 hours after the first dose of Probenecid on D2. Period 2: HSK16149 single dose on D1, 40mg, fasted; |
| B1 | Experimental | Drug: HSK16149，probenecid, cimetidinePeriod 1: HSK16149 single dose on D1, 40mg, fasted; Period 2: HSK16149 single dose on D2, 40mg, fasted; Cimetidine QID (200mg) on D1~D4. HSK16149 would be administered 1 hour after the first dose of Cimetidine on D2. |
| B2 | Experimental | Drug: HSK16149，probenecid, cimetidinePeriod 1: HSK16149 single dose on D2, 40mg, fasted; Cimetidine QID (200mg) on D1~D4. HSK16149 would be administered 1 hour after the first dose of Cimetidine on D2. Period 2: HSK16149 single dose on D1, 40mg, fasted; |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions;
- 18 years to 50 years (inclusive), male and female;
- Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Body mass index (BMI) : 18-28 kg/m2 (inclusive);
- Physical examination, vital sign measurements results were deemed appropriate by the investigator;
- Not in use of any drug within 2 weeks prior to screening;
Key exclusion criteria (21 listed)
- Have an allergic history to the main ingredients and/or any auxiliary materials in the research preparation, allergic diseases or allergies, or allergic history to pregabalin or gabapentin, or allergic history to pregabalin or gabapentin or sulfonamides;
- Have special requirements for diet and cannot follow the unified diet;
- The abnormal results of 12-lead electrocardiogram (ECG), chest X-ray (positive position) and routine laboratory tests (blood routine, blood biochemistry, urine routine and coagulation function) during the screening period have clinical significance and are judged by the researchers to be unsuitable to participate in this experiment;
- In the screening period, male QTcF>450 milliseconds (msec) and female QTcF>470 milliseconds (msec);
- dizziness or vertigo with clinical significance and requiring medical intervention, or history of inner ear diseases known to cause dizziness or vertigo;
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 |
|---|---|---|
| HSK16149，probenecid, cimetidine40mg HSK16149 single dose, fasted; 500mg probenecid QID from D1~D4 200mg cimetidine QID from D1~D4 | Drug | A1, A2, B1, B2 |
Primary outcome
Cmax
Time frame: From the start to 72 hours after administration
The maximun plasma concentration of HSK16149
AUC0-t
Time frame: From the start to 72 hours after administration
Area under the concentration-time curve from time zero to time of last quantifiable concentration
AUC0-inf
Time frame: From the start to 72 hours after administration
Area under the concentration-time curve from time zero extrapolated to infinite time
7 secondary outcomes
Tmax
Time frame: From the start to 72 hours after administration
t1/2
Time frame: From the start to 72 hours after administration
Vz
Time frame: From the start to 72 hours after administration
CL
Time frame: From the start to 72 hours after administration
Ae
Time frame: From the start to 72 hours after administration
Fe
Time frame: From the start to 72 hours after administration
CLr
Time frame: From the start to 72 hours after administration
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 7 Dec 2023.
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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 HSK16149，probenecid, cimetidine in people with PHN - Post-Herpetic Neuritis, run by Haisco Pharmaceutical Group Co., Ltd. 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 6 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 7 Dec 2023. 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?
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?
Cmax (time frame: From the start to 72 hours after administration). The study lists 3 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 7 Dec 2023.