Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-04 @ 9:37 AM
Study NCT ID:
NCT03758469
Status:
COMPLETED
Last Update Posted:
2019-08-20
First Post:
2018-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating Drug-Drug Interaction (DDI) Between HSK3486 Injectable Emulsion and Rifampin Capsules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000730813', 'term': 'HSK3486'}, {'id': 'D012293', 'term': 'Rifampin'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-19', 'studyFirstSubmitDate': '2018-11-25', 'studyFirstSubmitQcDate': '2018-11-28', 'lastUpdatePostDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak concentration (Cmax)', 'timeFrame': 'From the start of HSK3486 administration to 24 h after the start of administration on day 1'}, {'measure': 'Area under the concentration-time curve (AUC0-t, AUC0-∞)', 'timeFrame': 'From the start of HSK3486 administration to 24 h after the start of administration on day 1'}], 'secondaryOutcomes': [{'measure': 'Terminal elimination half life (t1/2)', 'timeFrame': 'From the start of HSK3486 administration to 24 h after the start of administration on day 1'}, {'measure': 'Time to fully awake', 'timeFrame': 'From the start of HSK3486 administration until the subjects is fully awake on day 1'}, {'measure': "MOAA/S(modified observer's assessment of alert /sedation)-time curve", 'timeFrame': 'From the start of HSK3486 administration until the subjects is fully awake on day 1', 'description': "Observe the change of modified observer's assessment of alert /sedation during the whole trial"}, {'measure': 'BIS(bispectral index)-time curve', 'timeFrame': 'From the start of HSK3486 administration to 60 min after the start of administration on day 1', 'description': 'Observe the changes of bispectral index during the whole trial'}, {'measure': 'Blood pressure', 'timeFrame': 'From the start of HSK3486 administration to 24 h after the start of administration on day 1', 'description': 'Observe the changes of blood pressure during the whole trial'}, {'measure': 'Heart rate', 'timeFrame': 'From the start of HSK3486 administration to 24 h after the start of administration on day 1', 'description': 'Observe the changes of heart rate during the whole trial'}, {'measure': 'Respiratory rate or blood oxygen saturation', 'timeFrame': 'From the start of HSK3486 administration to 24 h after the start of administration on day 1', 'description': 'Observe the changes of respiratory rate or blood oxygen saturation during the whole trial'}, {'measure': 'Blood routine test', 'timeFrame': 'From the start of HSK3486 administration to 24 h after the start of administration on day 1', 'description': 'Observe the changes of blood routine test during the whole trial'}, {'measure': 'Urine routine test', 'timeFrame': 'From the start of HSK3486 administration to 24 h after the start of administration on day 1', 'description': 'Observe the changes of urine routine test during the whole trial'}, {'measure': 'Blood biochemical examination', 'timeFrame': 'From the start of HSK3486 administration to 24 h after the start of administration on day 1', 'description': 'Observe the changes of Blood biochemical examination during the whole trial'}, {'measure': '12-Electrocardiogram', 'timeFrame': 'From the start of HSK3486 administration to 24 h after the start of administration on day 1', 'description': 'Observe the changes of heart rate, RR interval, QT interval , QTcF interval , PR interval and QRS interval of electrocardiogram during the whole trial'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'From the start of HSK3486 administration to 24 h after the start of administration on day 1', 'description': 'Safety endpoits'}, {'measure': 'Concurrent medications', 'timeFrame': 'From the start of HSK3486 administration to 24 h after the start of administration on day 1', 'description': 'Safety endpoits'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia', 'Sedation']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy males or females with full capacity for civil conduct, aged ≥18 and ≤45 years old. Both male and female subjects should be enrolled;\n2. 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;\n3. 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%;\n4. 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);\n5. 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;\n6. 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.\n\nExclusion Criteria:\n\n1. 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;\n2. In receipt of any one of the following medications or treatments during screening/baseline:\n\n 1. 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;\n 2. 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;\n 3. In receipt of rifampin within 4 weeks prior to screening;\n 4. 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);\n 5. In receipt of propofol, other sedatives/anesthetics and/or opioid analgesics or compounds containing analgesics within 1 week prior to baseline;\n 6. 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;\n3. A history or evidence of any one of the following diseases prior to screening/baseline:\n\n 1. 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);\n 2. 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;\n 3. History of GI tract diseases: Gastrointestinal obstruction, active GI bleed, potential for reflux and aspiration;\n4. Laboratory results that meet any of the following during screening/baseline:\n\n 1. Positive result for either HBsAg, HCV, HIV, or syphilis;\n 2. Abnormal hepatic or renal function confirmed after re-examination;\n\n * ALT or AST \\> 1×ULN;\n * Creatinine \\> 1×ULN;\n * TBIL \\> 1.0×ULN;\n5. 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;\n6. Smoke more than 5 cigarettes per day and a total of more than 60 cigarettes within 3 months prior to screening;\n7. Blood donation or blood loss ≥200 mL within 30 days prior to screening; plasma donation or plasma exchange within 7 days prior to screening;\n8. 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;\n9. Subjects expected to have surgery or hospitalization during the trial;\n10. Subjects unsuitable for arterial blood collection, such as subjects who have positive Allen's test;\n11. 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);\n12. Subjects judged by the investigator to be unsuitable for participating in this trial for any reason."}, 'identificationModule': {'nctId': 'NCT03758469', 'briefTitle': 'A Study Evaluating Drug-Drug Interaction (DDI) Between HSK3486 Injectable Emulsion and Rifampin Capsules', 'organization': {'class': 'INDUSTRY', 'fullName': 'Haisco Pharmaceutical Group Co., Ltd.'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'HSK3486-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HSK3486', 'description': '0.4 mg/kg', 'interventionNames': ['Drug: HSK3486']}, {'type': 'EXPERIMENTAL', 'label': 'rifampin , HSK3486', 'description': '600 mg;0.4 mg/kg', 'interventionNames': ['Drug: rifampin , HSK3486']}], 'interventions': [{'name': 'HSK3486', 'type': 'DRUG', 'description': 'Sequence 1: Intravenously infuse 0.4 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.', 'armGroupLabels': ['HSK3486']}, {'name': 'rifampin , HSK3486', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['rifampin , HSK3486']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Public Health Clinical Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sichuan Haisco Pharmaceutical Group Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}