Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-01-02 @ 6:21 AM
Study NCT ID:
NCT03714568
Status:
UNKNOWN
Last Update Posted:
2018-12-11
First Post:
2018-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic and Tolerance Study of TQ-A3326 in Healthy Participants.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000712047', 'term': 'TQ-A3326'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-09', 'studyFirstSubmitDate': '2018-05-28', 'studyFirstSubmitQcDate': '2018-10-18', 'lastUpdatePostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Serious Adverse Events (SAEs).', 'timeFrame': 'Day 1 up to Day 7 for non-SAEs .', 'description': 'SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements.', 'timeFrame': 'Day 1 up to Day 7 or Discharge.', 'description': 'Participants were assessed by investigator for any clinically significant changes in vital parameters like body temperature, respiratory rate, blood pressure, heart rate and weight. The assessment was performed by a calibrated sphygmomanometer and thermometer for blood pressure and temperature, respectively. Blood pressure and heart rate were measured after at least 5 minutes quiet seating of the subject. Weight was measured at the discharge. The criteria for clinically significant change was as per the investigators discretion.'}, {'measure': 'Number of Participants With Marked Abnormalities in Laboratory Findings.', 'timeFrame': 'Day 1 up to Day 7.', 'description': 'Laboratory marked abnormalities were defined as Hematocrit (low) as \\<0.85\\*pre-treatment value, Leukocytes (low) as \\<0.9\\*lower limit of normal, Aspartate Aminotransferase (high) as \\>1.25\\*upper limit of normal, Creatinine (high) as \\>1.33\\*pre-treatment value, Bicarbonate (high) as \\>1.2\\*upper limit of normal, Total Protein (high) as \\>1.1\\*upper limit of normal, Creatinine Kinase (high) as \\>1.5\\*upper limit of normal, Blood in Urine (high) as ≥ 2\\*upper limit of normal. Participants were fasted for at least 10 hours prior to the collection of blood specimens for clinical laboratory tests.'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax).', 'timeFrame': 'Pre-dose, 0.25hour, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour, 96hour, 120hour post-dosing on Day 1', 'description': 'Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data. The plasma samples were analyzed for TQ-A3326 using a validated liquid chromatography-tandem mass spectrometric assay.\n\n2）Grade 4 hematology toxicity'}, {'measure': 'Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-T]).', 'timeFrame': 'Pre-dose, 0.25hour, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour, 96hour, 120hour post-dosing on Day 1.', 'description': 'Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration. It was calculated as the sum of linear trapezoids using non-compartmental analysis. The plasma samples were analyzed for TQ-A3326 using a validated liquid chromatography-tandem mass spectrometric assay.'}, {'measure': 'Area Under the Plasma Concentration-time Curve From Time Zero (AUC[INF]) Extrapolated to Infinite Time.', 'timeFrame': 'Pre-dose, 0.25hour, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour, 96hour, 120hour post-dosing on Day 1.', 'description': 'Area under the plasma concentration-time curve from time zero extrapolated to infinite time was estimated as sum of AUC(0-T) and the extrapolated area, computed by the quotient of the last observable concentration and λ, where λ was the slopes of the terminal phases of the plasma concentration-time profiles. The plasma samples were analyzed for TQ-A3326 using a validated liquid chromatography-tandem mass spectrometric assay.'}, {'measure': 'Time to Reach Maximum Plasma Concentration (Tmax).', 'timeFrame': 'Pre-dose, 0.25hour, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour, 96hour, 120hour post-dosing on Day 1.', 'description': 'Tmax was defined as the time required to reach maximum observed plasma concentration. The plasma samples were analyzed for TQ-A3326 using a validated liquid chromatography-tandem mass spectrometric assay.'}, {'measure': 'Plasma Half-life (T-half)', 'timeFrame': 'Pre-dose, 0.25hour, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour, 96hour, 120hour post-dosing on Day 1.', 'description': 'Plasma half-life was defined as the time required for one half of the total amount of administered drug eliminated from the body. The plasma samples were analyzed for TQ-A3326 using a validated liquid chromatography-tandem mass spectrometric assay.'}, {'measure': 'Apparent Total Body Clearance (CLT/F)', 'timeFrame': 'Pre-dose, 0.25hour, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour, 96hour, 120hour post-dosing on Day 1.', 'description': 'Apparent total body clearance (CLT/F) was calculated as Dose/AUC(INF), where CLT was the clearance of the drug and F was the absolute oral bioavailability. The plasma samples were analyzed for TQ-A3326 using a validated liquid chromatography-tandem mass spectrometric assay.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pharmacokinetic']}, 'descriptionModule': {'briefSummary': 'To study the single dose and multi-doses pharmacokinetic characteristics and tolerance of TQ-A3326 in the human body；To study the transformation of TQ-A3326；To study the effect of the food on the pharmacokinetic characteristics of TQ-A3326.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male or female, age 18 to 60 years, inclusive.\n* The body weight of male is not less than 50kg, and female is not less than 45kg. All participants' body mass index (BMI) is between 19\\~26.\n* Adequate blood cell counts, kidney function and liver function.\n* Healthy participants should participate in the study voluntarily and sign informed consent.\n\nExclusion Criteria:\n\n* Subjects with known allergy to the similar products tested.\n* Subject is on a special diet (for example subject is vegetarian).\n* Medical demographics with evidence of clinically significant deviation from normal medical condition.\n* Female subjects who were pregnant or nursing.\n* Results of laboratory tests which are clinically significant.\n* Acute infection within one week preceding first study drug administration.\n* History of drug or alcohol abuse.\n* Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.\n* Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.\n* ale subjects (or their partner) or female subjects have the unprotective sex behavior or have a planned pregnancy during the trial."}, 'identificationModule': {'nctId': 'NCT03714568', 'briefTitle': 'Pharmacokinetic and Tolerance Study of TQ-A3326 in Healthy Participants.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'Pharmacokinetic and Tolerance Study in Healthy Participants: a Single-centre, Randomized, Double-blind, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'ZDTQ-A3326-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TQ-A3326', 'description': 'TQ-A3326 (15mg-180mg: p.o. single dose; 60mg: p.o. multi-doses）', 'interventionNames': ['Drug: TQ-A3326']}, {'type': 'EXPERIMENTAL', 'label': 'placebo', 'description': 'Placebo(15-180mg: p.o. single dose; 60mg: p.o. multi-doses)', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'TQ-A3326', 'type': 'DRUG', 'description': 'TQ-A3326 (15mg-180mg: p.o. single dose; 60mg: p.o. multi-doses）', 'armGroupLabels': ['TQ-A3326']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Placebo(15-180mg: p.o. single dose; 60mg: p.o. multi-doses)', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410015', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Xin, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Third Hospital of Changsha', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Li Xin, Doctor', 'role': 'CONTACT', 'email': 'naloxone@163.com', 'phone': '+86-731-85171383'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}