AnesthesiaPhase 1NCT03758469
A Study Evaluating Drug-Drug Interaction (DDI) Between HSK3486 Injectable Emulsion and Rifampin Capsules
A Phase 1 study testing HSK3486 and rifampin , HSK3486 in people with Anesthesia and Sedation, run by Sichuan Haisco Pharmaceutical Group Co., Ltd at 1 site in China.
Trial summary
This is a Phase I, single-center, open-label, randomized,two-way crossover, propofol-controlled, two-stage study evaluating the safety and pharmacokinetics/pharmacodynamics of IV maintenance dose and IV single loade dose plus maintenance dose of HSK3486 emulsion for injection in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Sedation
- What is being tested?
- HSK3486 and rifampin , HSK3486
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 14 Dec 2018to 10 Mar 2019
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or females with full capacity for civil conduct, aged ≥18 and ≤45 years old. Both male and female subjects should be enrolled;
- Male subjects weighing ≥50 kg, female subjects weighing ≥45 kg. All subjects should have a body mass index (BMI) of ≥19.0 and ≤26.0 kg/m2;
- Blood pressure between 100-139/60-89 mmHg; heart rate between 60-99 beats/min; body temperature between 35.8-37.5 °C; respiratory rate between 12-20 breaths/min; SpO2 when inhaling ≥95%;
- Normal physical examinations, laboratory examinations (blood routine, blood biochemistry and urine routine), and 12-lead electrocardiogram (ECG), or abnormal but without clinical significance as judged by the investigators; no significantly potential difficult airway (modified Mallampati score I-II);
- No previous history of major organ primary diseases, such as liver, kidneys, digestive tract, blood, and metabolic diseases; no history of malignant hyperthermia and other genetic conditions; no history of mental/neurological diseases; no history of epilepsy; no contraindications for deep sedation/general anesthesia; no clinically significant history of anesthesia accidents;
- Subjects must understand the procedures and methods of this study, and be willing to provide informed consent and to complete the trial in strict accordance with trial protocol.
Who cannot join
- Known sensitivity to excipients in HSK3486 injectable emulsion (soybean oil, glycerin, triglyceride, egg lecithin, sodium oleate and sodium hydroxide), rifampin, or contraindications mentioned in the prescribing information of rifampin; history of drug allergies (including anesthetics), allergic diseases, or those with hyperactive immune response;
- In receipt of any one of the following medications or treatments during screening/baseline:
- History of drug abuse or any signs of chronic benzodiazepines use (such as insomnia, anxiety, spasms) within 3 months prior to screening, or a positive urine drug test during baseline;
- Participated in clinical trials involving any medications or medical devices within 3 months prior to screening, or subjects who have participated in 3 or more drug clinical trials within the past year;
- In receipt of rifampin within 4 weeks prior to screening;
- Serious infection, trauma or major surgery within 4 weeks prior to screening; or acute disease with clinical significance (determined by the investigator) within 2 weeks prior to screening, including GI diseases or infections (such as respiratory or CNS infections);
Show all 26Show fewer
- In receipt of propofol, other sedatives/anesthetics and/or opioid analgesics or compounds containing analgesics within 1 week prior to baseline;
- In receipt of prescription drugs, Chinese herbal medicines, over-the-counter drugs or food supplements (such as vitamins and calcium supplements) other than contraceptives, paracetamol, oral non-steroidal anti-inflammatory drugs, topical over-the-counter preparations, within 2 weeks prior to baseline; unless the principal investigator (PI) and the sponsor agree that the medication has no effect on the safety and PK/PD results of the trial;
- A history or evidence of any one of the following diseases prior to screening/baseline:
- History of cardiovascular diseases such as: postural hypotension, severe arrhythmia, heart failure, Adams-Stokes syndrome, unstable angina, myocardial infarction within 6 months before screening, tachycardia/bradycardia requiring medication, third-degree atrioventricular block or QTcF interval ≥450 ms (Fridericia's correction formula);
- Respiratory insufficiency, history of obstructive pulmonary disease, history of asthma, sleep apnea; history of failed tracheal intubation; history of bronchospasm requiring treatment within 3 months prior to screening; acute respiratory infection, and with obvious symptoms such as fever, wheezing, nasal congestion or cough within 1 week prior to baseline;
- History of GI tract diseases: Gastrointestinal obstruction, active GI bleed, potential for reflux and aspiration;
- Laboratory results that meet any of the following during screening/baseline:
- Positive result for either HBsAg, HCV, HIV, or syphilis;
- Abnormal hepatic or renal function confirmed after re-examination;
- ALT or AST > 1×ULN;
- Creatinine > 1×ULN;
- TBIL > 1.0×ULN;
- History of alcohol abuse within 3 months prior to screening, abuse defined as average of > 2 units of alcohol per day (1 unit = 360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine), or positive result for breath alcohol test during baseline;
- Smoke more than 5 cigarettes per day and a total of more than 60 cigarettes within 3 months prior to screening;
- Blood donation or blood loss ≥200 mL within 30 days prior to screening; plasma donation or plasma exchange within 7 days prior to screening;
- Subjects who consume any beverages or foods containing alcohol, grapefruit juice or methylxanthine (such as coffee, tea, coca-cola, chocolate, functional drinks), to participate in strenuous physical activities and other factors that may affect drug absorption, distribution, metabolism, and excretion within 2 days prior to enrollment; subjects who are unable to fast for 8 hours prior to dose administration;
- Subjects expected to have surgery or hospitalization during the trial;
- Subjects unsuitable for arterial blood collection, such as subjects who have positive Allen's test;
- Women who are pregnant or breastfeeding; women of child-bearing potential or men who are unwilling to use contraception during the trial; subjects who are planning pregnancy within 1 month after the completion of the trial (including male subjects);
- Subjects judged by the investigator to be unsuitable for participating in this trial for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Open-Label, Randomized, Two-Stage, Two-Way Crossover Study Evaluating Drug-Drug Interaction (DDI) Between HSK3486 Injectable Emulsion and Rifampin Capsules in Healthy Subjects.
This is a Phase I, single-center, open-label, randomized,two-way crossover, propofol-controlled, two-stage study evaluating the safety and pharmacokinetics/pharmacodynamics of IV maintenance dose and IV single loade dose plus maintenance dose of HSK3486 emulsion for injection in healthy subjects.
- Conditions
- Anesthesia, Sedation
- Being tested
- HSK3486, rifampin , HSK3486
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK3486Drug
Sequence 1: Intravenously infuse 0.4 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.
rifampin , HSK3486Drug
Sequence 2: Orally take 600 mg rifampin once a day for 8 consecutive days in the morning on an empty stomach, followed by 1 min intravenous infusion of 0.4 mg/kg HSK3486 30 min later.
| Study group | Role | What they receive |
|---|---|---|
| HSK3486 | Experimental | 0.4 mg/kg Receives: Drug: HSK3486 |
| rifampin , HSK3486 | Experimental | 600 mg;0.4 mg/kg Receives: Drug: rifampin , HSK3486 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak concentration (Cmax)
Measured: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Area under the concentration-time curve (AUC0-t, AUC0-∞)
Measured: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Secondary outcomes (13)
Terminal elimination half life (t1/2)
Measured: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Time to fully awake
Measured: From the start of HSK3486 administration until the subjects is fully awake on day 1
MOAA/S(modified observer's assessment of alert /sedation)-time curve
Observe the change of modified observer's assessment of alert /sedation during the whole trial
Measured: From the start of HSK3486 administration until the subjects is fully awake on day 1
BIS(bispectral index)-time curve
Observe the changes of bispectral index during the whole trial
Measured: From the start of HSK3486 administration to 60 min after the start of administration on day 1
Blood pressure
Observe the changes of blood pressure during the whole trial
Measured: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Heart rate
Observe the changes of heart rate during the whole trial
Measured: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Respiratory rate or blood oxygen saturation
Observe the changes of respiratory rate or blood oxygen saturation during the whole trial
Measured: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Blood routine test
Observe the changes of blood routine test during the whole trial
Measured: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Urine routine test
Observe the changes of urine routine test during the whole trial
Measured: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Blood biochemical examination
Observe the changes of Blood biochemical examination during the whole trial
Measured: From the start of HSK3486 administration to 24 h after the start of administration on day 1
12-Electrocardiogram
Observe the changes of heart rate, RR interval, QT interval , QTcF interval , PR interval and QRS interval of electrocardiogram during the whole trial
Measured: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Number of patients with adverse events
Safety endpoits
Measured: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Concurrent medications
Safety endpoits
Measured: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start14 Dec 2018
- Primary completion31 Jan 2019
- Study completion10 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758469
- Sponsor's protocol ID
- HSK3486-103
- Status last verified
- Nov 2018
- First submitted
- 25 Nov 2018
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label, Randomized, Two-Stage, Two-Way Crossover Study Evaluating Drug-Drug Interaction (DDI) Between HSK3486 Injectable Emulsion and Rifampin Capsules in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT03758469
- Acronym / sponsor ID
- HSK3486-103
- Conditions
- Anesthesia, Sedation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 10 Mar 2019 (actual)
- First posted
- 29 Nov 2018 (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 a Phase I, single-center, open-label, randomized,two-way crossover, propofol-controlled, two-stage study evaluating the safety and pharmacokinetics/pharmacodynamics of IV maintenance dose and IV single loade dose plus maintenance dose of HSK3486 emulsion for injection in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSK3486 | Experimental | Drug: HSK34860.4 mg/kg |
| rifampin , HSK3486 | Experimental | Drug: rifampin , HSK3486600 mg;0.4 mg/kg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy males or females with full capacity for civil conduct, aged ≥18 and ≤45 years old. Both male and female subjects should be enrolled;
- Male subjects weighing ≥50 kg, female subjects weighing ≥45 kg. All subjects should have a body mass index (BMI) of ≥19.0 and ≤26.0 kg/m2;
- Blood pressure between 100-139/60-89 mmHg; heart rate between 60-99 beats/min; body temperature between 35.8-37.5 °C; respiratory rate between 12-20 breaths/min; SpO2 when inhaling ≥95%;
- Normal physical examinations, laboratory examinations (blood routine, blood biochemistry and urine routine), and 12-lead electrocardiogram (ECG), or abnormal but without clinical significance as judged by the investigators; no significantly potential difficult airway (modified Mallampati score I-II);
- No previous history of major organ primary diseases, such as liver, kidneys, digestive tract, blood, and metabolic diseases; no history of malignant hyperthermia and other genetic conditions; no history of mental/neurological diseases; no history of epilepsy; no contraindications for deep sedation/general anesthesia; no clinically significant history of anesthesia accidents;
Key exclusion criteria (26 listed)
- Known sensitivity to excipients in HSK3486 injectable emulsion (soybean oil, glycerin, triglyceride, egg lecithin, sodium oleate and sodium hydroxide), rifampin, or contraindications mentioned in the prescribing information of rifampin; history of drug allergies (including anesthetics), allergic diseases, or those with hyperactive immune response;
- In receipt of any one of the following medications or treatments during screening/baseline:
- A history or evidence of any one of the following diseases prior to screening/baseline:
- Laboratory results that meet any of the following during screening/baseline:
- History of alcohol abuse within 3 months prior to screening, abuse defined as average of > 2 units of alcohol per day (1 unit = 360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine), or positive result for breath alcohol test during baseline;
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 |
|---|---|---|
| HSK3486Sequence 1: Intravenously infuse 0.4 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min. | Drug | HSK3486 |
| rifampin , HSK3486Sequence 2: Orally take 600 mg rifampin once a day for 8 consecutive days in the morning on an empty stomach, followed by 1 min intravenous infusion of 0.4 mg/kg HSK3486 30 min later. | Drug | rifampin , HSK3486 |
Primary outcome
Peak concentration (Cmax)
Time frame: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Area under the concentration-time curve (AUC0-t, AUC0-∞)
Time frame: From the start of HSK3486 administration to 24 h after the start of administration on day 1
13 secondary outcomes
Terminal elimination half life (t1/2)
Time frame: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Time to fully awake
Time frame: From the start of HSK3486 administration until the subjects is fully awake on day 1
MOAA/S(modified observer's assessment of alert /sedation)-time curve
Time frame: From the start of HSK3486 administration until the subjects is fully awake on day 1
BIS(bispectral index)-time curve
Time frame: From the start of HSK3486 administration to 60 min after the start of administration on day 1
Blood pressure
Time frame: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Heart rate
Time frame: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Respiratory rate or blood oxygen saturation
Time frame: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Blood routine test
Time frame: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Urine routine test
Time frame: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Blood biochemical examination
Time frame: From the start of HSK3486 administration to 24 h after the start of administration on day 1
12-Electrocardiogram
Time frame: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Number of patients with adverse events
Time frame: From the start of HSK3486 administration to 24 h after the start of administration on day 1
Concurrent medications
Time frame: From the start of HSK3486 administration to 24 h after the start of administration on day 1
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 20 Aug 2019.
Related trials for Anesthesia
Not yet recruiting
Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty: A Randomized Controlled Trial
Anaesthetic Requirements During Total Hip Arthroplasty
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
RecruitingPhase 4
Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery
Cesarean Delivery, Cesarean Delivery; Neuraxial Opioids
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Recruiting
Monitored Anesthesia Care and Soft Tissue Infiltration With Local Anesthesia Feasibility Trial
Hip Fracture Surgeries, Intertrochanteric Fracture
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 HSK3486 and rifampin , HSK3486 in people with Anesthesia and Sedation, run by Sichuan 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 26 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 20 Aug 2019. 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?
Peak concentration (Cmax) (time frame: From the start of HSK3486 administration to 24 h after the start of administration on day 1). The study lists 2 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 20 Aug 2019.