AnesthesiaPhase 1NCT03751956
A Study Evaluating the Mass Balance of [14C]HSK3486 Emulsion Injection in Healthy Adults.
A Phase 1 study testing HSK3486 in people with Anesthesia and Sedation, run by Sichuan Haisco Pharmaceutical Group Co., Ltd at 1 site in China.
Trial summary
This study is designed to evaluate the mass balance and biotransformation pathways of HSK3486 in healthy Chinese male subjects administered with a single intravenous dose of [14C]HSK3486, so as to characterize the drug's general pharmacokinetics and safety in humans and provide supportive data for reasonable use. Read more about this study
- Who is it for?
- Ages 18 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Sedation
- What is being tested?
- HSK3486
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2019to 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 49 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects enrolled in this study are required to meet all of the following:
- Healthy Chinese males aged 18-49 years old (inclusive);
- Body weight: body mass index (BMI) between 19-26 kg/m2 (inclusive); weight should be no less than 50 kg; weight difference between the lightest and the heaviest subjects enrolled should be no more than 10 kg;
- Vital signs: blood pressure between 90-140/60-90 mmHg; heart rate or pulse between 60-99 beats/min; body temperature (ear temperature) between 35.5-37.1 °C; respiratory rate between 12-24 breaths/min; blood oxygen saturation when inhaling ≥ 96% (inclusive);
- Normal major organ function, e.g. routine blood test, blood biochemistry, routine urinalysis, feces and fecal occult blood test, and blood coagulation are all normal, or abnormal with no clinical significance as judged by the investigators;
- Subjects who voluntarily sign the informed consent form, able to communicate well with the investigator and complete all trial procedures in accordance with the protocol.
Who cannot join
- Subjects who meet any of the following will be excluded:
- Subjects with clinically significant abnormalities during screening in physical examinations, laboratory tests, 12-lead ECG, chest X-ray or airway evaluation, including airway evaluation of a modified Mallampati score of IV; subjects with positive test result for hepatitis B surface antigen, hepatitis B e antigen, hepatitis C antibody, HIV antibody or syphilis antibody;
- Medication history: In receipt of any other investigational drug or participated in any drug or medical device clinical trial within 3 months before screening; or in receipt of propofol, other sedative/narcotic drugs and/or opioid analgesics or compounds containing analgesics within 72 hours prior to screening; or in receipt of any 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, and topical over-the-counter preparations within 2 weeks before screening; subjects can only be enrolled given the condition that the primary investigator (PI) and the sponsor agree that the drug used has no effect on the safety and mass balance results of the trial;
- Past and current medical history:
- A Subjects with a history of any severe disease, or concomitant diseases or abnormalities that may affect the test results as judged by the investigator, including but not limited to diseases or abnormalities in the circulatory system, endocrine system, neurological system, digestive system, urinary system, hematologic system, immune system, mental and metabolic aspects; B Subjects who have a past or current history of cardiovascular disease, including: heart failure, ischemic heart disease, long QT syndrome, arrhythmia requiring medication; a family history of Adams-Stokes syndrome or long QT syndrome; QTcF interval ≥ 450 ms (corrected by Fridericia's formula); C Subjects who have a past or current history of respiratory disease, including: obstructive pulmonary disease, asthma, or a history of bronchospasm requiring treatment within 3 months prior to screening; acute respiratory infections within 1 week prior to screening, with significant fever, wheezing, nasal congestion, and coughing.
- D Subjects who have a past or current history of gastrointestinal disease, including: gastroesophageal reflux, hemorrhoids or perianal disease with fecal blood, habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease, etc.; E Subjects who have major surgery within 6 months before screening, or surgical incision not completely healed. Major surgery includes, but is not limited to any surgery that has a significant risk of bleeding, prolonged general anesthesia, incisional biopsy or significant traumatic injury; F Subjects with hyperactive immune response, including: sensitive to excipients of HSK3486 emulsion injections (soybean oil, glycerin, triglyceride, egg lecithin, sodium oleate and sodium hydroxide), history of drug allergies (including anesthetics), or other allergic diseases (such as allergic to any food ingredient or have special dietary requirements and cannot follow a uniform diet);
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- Alcohol abuse or history of alcohol abuse within 3 months prior to screening, e.g. > 14 units of alcohol consumption per week (1 unit = 360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine), or positive result for breath alcohol test at screening;
- Consumption of more than 5 cigarettes daily within 3 months before screening or habitual use of nicotine-containing products which cannot be withdrawn during the trial; history of respiratory irritation symptoms caused by smoking;
- Chronic drug abuse or use of soft drugs (such as marijuana) within 3 months before screening; or use of hard drugs (such as cocaine, amphetamines, phencyclidine) within 1 year before screening; or any signs of chronic benzodiazepines use (such as insomnia, anxiety) or positive urine drug test during screening;
- Habitual consumption of grapefruit juice or excessive tea, coffee and/or caffeinated beverages which cannot be withdrawn during the trial;
- Engaged in work requiring long-term exposure to radioactive conditions; or significant radioactive exposure within 1 year prior to the trial (≥ 2 chest/ abdominal CT, or ≥ 3 other types of X-ray tests); or those who have participated in radiolabelling testing;
- Fertility planner during the trial period and within 1 year after the completion of the trial, or subjects or their spouses who refuse to take strict contraceptive measures (including taking condom, contraceptive sponge, contraceptive gel, diaphragm, intrauterine devices, oral or injectable contraceptives, subcutaneous implants, etc.) during the trial and within 1 year after the completion of the trial;
- Subjects who received blood transfusion within 1 month before screening or who had blood loss or blood donation ≥ 200 mL, or subjects who had plasma donation or plasma exchange within 7 days before the trial;
- Subject deemed unsuitable by the investigator for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study Evaluating the Mass Balance and Biotransformation of [14C]HSK3486 Emulsion Injection in Healthy Chinese Male Adults.
This study is designed to evaluate the mass balance and biotransformation pathways of HSK3486 in healthy Chinese male subjects administered with a single intravenous dose of [14C]HSK3486, so as to characterize the drug's general pharmacokinetics and safety in humans and provide supportive data for reasonable use.
- Conditions
- Anesthesia, Sedation
- Being tested
- HSK3486
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK3486Drug
The subjects will receive an intravenous injection of 0.8 μCi/0.4 mg/kg of [14C]HSK3486 emulsion injection (i.e., a subject with the body weight of 60 kg is administered with a radiation dose of 48 μCi).
| Study group | Role | What they receive |
|---|---|---|
| HSK3486 | Experimental | 0.8 μCi/0.4 mg/kg of [14C]HSK3486 emulsion injection Receives: Drug: HSK3486 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of cumulative drug excretion of [14C]HSK3486 on biological specimens(urine and faeces) accounting for total radiation drug dose
Though collecting different periods of biological specimens(urine and faeces) , detecting their respective drug excretion of [14C]HSK3486，calculating the total cumulative excretion amount and relevant proportion of each kind of specimen(urine or faeces)
Measured: From the start of administration through 168 hours after administration
Maximum Plasma Concentration [Cmax] of total radioactivity and non-radiolabeled HSK3486 respectively
Pharmacokinetic Measures
Measured: From the start of administration through 168 hours after administration
Time to plasma peak concentration[Tmax] of total radioactivity and non-radiolabeled HSK3486 respectively
Pharmacokinetic Measures
Measured: From the start of administration through 168 hours after administration
Clearance half-life[t1/2] of total radioactivity and non-radiolabeled HSK3486 respectively
Pharmacokinetic Measures
Measured: From the start of administration through 168 hours after administration
Area Under the Curve [AUC] of total radioactivity and non-radiolabeled HSK3486 respectively
Pharmacokinetic Measures
Measured: From the start of administration through 168 hours after administration
The metabolite analysis of [14C]HSK3486 in human body
Pharmacokinetic Measures
Measured: from the start of administration through 168 hours after administration
Secondary outcomes (13)
Number of patients with adverse events and serious adverse events
Safety Measures
Measured: From the time the subject is being screened to the end of the trial( nearly 168h after drug administration)
Blood routine test
Observe the changes of blood routine test during the whole trial
Measured: At the time of subject is being screened and at the end of study( nearly 168h after drug administration)
Urine routine test
Observe the changes of urine routine test during the whole trial
Measured: At the time of subject is being screened and at the end of study( nearly 168h after drug administration)
Blood biochemical examination
Observe the changes of Blood biochemical examination during the whole trial
Measured: At the time of subject is being screened and at the end of study( nearly 168h after drug administration)
Blood pressure
Observe the changes of blood pressure during the whole trial
Measured: From the time the subject is being screened to the end of the trial( nearly 168h after drug administration)
Heart rate or pulse
Observe the changes of heart rate or pulse during the whole trial
Measured: From the time the subject is being screened to the end of the trial( nearly 168h after drug administration)
Respiratory rate or blood oxygen saturation
Observe the changes of respiratory rate or blood oxygen saturation during the whole trial
Measured: From the time the subject is being screened to the end of the trial( nearly 168h after drug administration)
Heart rate of electrocardiogram
Observe the changes of heart rate of electrocardiogram during the whole trial
Measured: From the time the subject is being screened to the end of the trial( nearly 168h after drug administration)
RR interval of electrocardiogram
Observe the changes of RR interval of electrocardiogram during the whole trial
Measured: From the time the subject is being screened to the end of the trial( nearly 168h after drug administration)
QT interval of electrocardiogram
Observe the changes of QT interval of electrocardiogram during the whole trial
Measured: From the time the subject is being screened to the end of the trial( nearly 168h after drug administration)
QTcF interval of electrocardiogram
Observe the changes of QTcF interval of electrocardiogram during the whole trial
Measured: From the time the subject is being screened to the end of the trial( nearly 168h after drug administration)
PR interval of electrocardiogram
Observe the changes of PR interval of electrocardiogram during the whole trial
Measured: From the time the subject is being screened to the end of the trial( nearly 168h after drug administration)
QRS interval of electrocardiogram
Observe the changes of QRS interval of electrocardiogram during the whole trial
Measured: From the time the subject is being screened to the end of the trial( nearly 168h after drug administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start6 Jan 2019
- Primary completion28 Feb 2019
- Study completion10 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 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
- NCT03751956
- Sponsor's protocol ID
- HSK3486-104-2
- Status last verified
- Oct 2019
- First submitted
- 18 Nov 2018
- Last updated
- 28 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bian Y, Zhang H, Ma S, Jiao Y, Yan P, Liu X, Ma S, Xiong Y, Gu Z, Yu Z, Huang C, Miao L. Mass balance, pharmacokinetics and pharmacodynamics of intravenous HSK3486, a novel anaesthetic, administered to healthy subjects. Br J Clin Pharmacol. 2021 Jan;87(1):93-105. doi: 10.1111/bcp.14363. Epub 2020 Aug 3.
PubMed 32415708
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating the Mass Balance and Biotransformation of [14C]HSK3486 Emulsion Injection in Healthy Chinese Male Adults.
- ClinicalTrials.gov ID
- NCT03751956
- Acronym / sponsor ID
- HSK3486-104-2
- Conditions
- Anesthesia, Sedation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2019 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 10 Mar 2019 (actual)
- First posted
- 23 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 study is designed to evaluate the mass balance and biotransformation pathways of HSK3486 in healthy Chinese male subjects administered with a single intravenous dose of [14C]HSK3486, so as to characterize the drug's general pharmacokinetics and safety in humans and provide supportive data for reasonable use.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HSK3486 | Experimental | Drug: HSK34860.8 μCi/0.4 mg/kg of [14C]HSK3486 emulsion injection |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects enrolled in this study are required to meet all of the following:
Key exclusion criteria (14 listed)
- Subjects who meet any of the following will be excluded:
- A Subjects with a history of any severe disease, or concomitant diseases or abnormalities that may affect the test results as judged by the investigator, including but not limited to diseases or abnormalities in the circulatory system, endocrine system, neurological system, digestive system, urinary system, hematologic system, immune system, mental and metabolic aspects; B Subjects who have a past or current history of cardiovascular disease, including: heart failure, ischemic heart disease, long QT syndrome, arrhythmia requiring medication; a family history of Adams-Stokes syndrome or long QT syndrome; QTcF interval ≥ 450 ms (corrected by Fridericia's formula); C Subjects who have a past or current history of respiratory disease, including: obstructive pulmonary disease, asthma, or a history of bronchospasm requiring treatment within 3 months prior to screening; acute respiratory infections within 1 week prior to screening, with significant fever, wheezing, nasal congestion, and coughing.
- D Subjects who have a past or current history of gastrointestinal disease, including: gastroesophageal reflux, hemorrhoids or perianal disease with fecal blood, habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease, etc.; E Subjects who have major surgery within 6 months before screening, or surgical incision not completely healed. Major surgery includes, but is not limited to any surgery that has a significant risk of bleeding, prolonged general anesthesia, incisional biopsy or significant traumatic injury; F Subjects with hyperactive immune response, including: sensitive to excipients of HSK3486 emulsion injections (soybean oil, glycerin, triglyceride, egg lecithin, sodium oleate and sodium hydroxide), history of drug allergies (including anesthetics), or other allergic diseases (such as allergic to any food ingredient or have special dietary requirements and cannot follow a uniform diet);
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 |
|---|---|---|
| HSK3486The subjects will receive an intravenous injection of 0.8 μCi/0.4 mg/kg of [14C]HSK3486 emulsion injection (i.e., a subject with the body weight of 60 kg is administered with a radiation dose of 48 μCi). | Drug | HSK3486 |
Primary outcome
Percentage of cumulative drug excretion of [14C]HSK3486 on biological specimens(urine and faeces) accounting for total radiation drug dose
Time frame: From the start of administration through 168 hours after administration
Though collecting different periods of biological specimens(urine and faeces) , detecting their respective drug excretion of [14C]HSK3486，calculating the total cumulative excretion amount and relevant proportion of each kind of specimen(urine or faeces)
Maximum Plasma Concentration [Cmax] of total radioactivity and non-radiolabeled HSK3486 respectively
Time frame: From the start of administration through 168 hours after administration
Pharmacokinetic Measures
Time to plasma peak concentration[Tmax] of total radioactivity and non-radiolabeled HSK3486 respectively
Time frame: From the start of administration through 168 hours after administration
Pharmacokinetic Measures
Clearance half-life[t1/2] of total radioactivity and non-radiolabeled HSK3486 respectively
Time frame: From the start of administration through 168 hours after administration
Pharmacokinetic Measures
Area Under the Curve [AUC] of total radioactivity and non-radiolabeled HSK3486 respectively
Time frame: From the start of administration through 168 hours after administration
Pharmacokinetic Measures
The metabolite analysis of [14C]HSK3486 in human body
Time frame: from the start of administration through 168 hours after administration
Pharmacokinetic Measures
13 secondary outcomes
Number of patients with adverse events and serious adverse events
Time frame: From the time the subject is being screened to the end of the trial( nearly 168h after drug administration)
Blood routine test
Time frame: At the time of subject is being screened and at the end of study( nearly 168h after drug administration)
Urine routine test
Time frame: At the time of subject is being screened and at the end of study( nearly 168h after drug administration)
Blood biochemical examination
Time frame: At the time of subject is being screened and at the end of study( nearly 168h after drug administration)
Blood pressure
Time frame: From the time the subject is being screened to the end of the trial( nearly 168h after drug administration)
Heart rate or pulse
Time frame: From the time the subject is being screened to the end of the trial( nearly 168h after drug administration)
Respiratory rate or blood oxygen saturation
Time frame: From the time the subject is being screened to the end of the trial( nearly 168h after drug administration)
Heart rate of electrocardiogram
Time frame: From the time the subject is being screened to the end of the trial( nearly 168h after drug administration)
RR interval of electrocardiogram
Time frame: From the time the subject is being screened to the end of the trial( nearly 168h after drug administration)
QT interval of electrocardiogram
Time frame: From the time the subject is being screened to the end of the trial( nearly 168h after drug administration)
QTcF interval of electrocardiogram
Time frame: From the time the subject is being screened to the end of the trial( nearly 168h after drug administration)
PR interval of electrocardiogram
Time frame: From the time the subject is being screened to the end of the trial( nearly 168h after drug administration)
QRS interval of electrocardiogram
Time frame: From the time the subject is being screened to the end of the trial( nearly 168h after drug 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 28 Oct 2019.
- Derived from this study: PubMed 32415708Bian Y, Zhang H, Ma S, Jiao Y, Yan P, Liu X, Ma S, Xiong Y, Gu Z, Yu Z, Huang C, Miao L. Mass balance, pharmacokinetics and pharmacodynamics of intravenous HSK3486, a novel anaesthetic, administered to healthy subjects. Br J Clin Pharmacol. 2021 Jan;87(1):93-105. doi: 10.1111/bcp.14363. Epub 2020 Aug 3.
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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 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 14 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 28 Oct 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?
Percentage of cumulative drug excretion of [14C]HSK3486 on biological specimens(urine and faeces) accounting for total radiation drug dose (time frame: From the start of administration through 168 hours after administration). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03751956, which also lists 1 linked publication.
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 28 Oct 2019.