Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2026-02-03 @ 7:42 PM
Study NCT ID:
NCT03010059
Status:
COMPLETED
Last Update Posted:
2025-02-03
First Post:
2017-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Relative Bioavailability of JNJ64041575 Administered as 2 Different New Concept Formulations (Oral Suspension and Tablet) Compared to Their Respective Current Formulations, and to Assess the Effect of Food on the Pharmacokinetics of the 2 New Concept Formulations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000597470', 'term': "4'-chloromethyl-2'-deoxy-3',5'-di-O-isobutyryl-2'-fluorocytidine"}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2017-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2017-01-03', 'studyFirstSubmitQcDate': '2017-01-03', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax) of ALS-008112 (JNJ-63549109)', 'timeFrame': 'Up to Day 8', 'description': 'Cmax is the maximum observed plasma concentration.'}, {'measure': 'Area Under Plasma Concentration Curve from time zero to the last quantifiable (AUC [0-last]) of ALS-008112 (JNJ-63549109)', 'timeFrame': 'Up to Day 8', 'description': 'Area under the plasma concentration time curve (AUC) from time 0 to the time of the last measurable (non below quantification limit \\[non BQL\\]) concentration, calculated by linear trapezoidal summation.'}, {'measure': 'Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of ALS-008112 (JNJ-63549109)', 'timeFrame': 'Up to Day 8', 'description': 'The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time calculated as the sum of AUC (0-last) and C (0-last)/ lambda(z); wherein AUC (0-last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.'}], 'secondaryOutcomes': [{'measure': 'Time to Reach Maximum Concentration (Tmax) ALS-008112 (JNJ-63549109)', 'timeFrame': 'Up to Day 8', 'description': 'Tmax is defined as actual sampling time to reach maximum observed plasma concentration.'}, {'measure': 'Apparent Terminal Elimination Rate Constant (lambda z) of ALS-008112 (JNJ-63549109)', 'timeFrame': 'Up to Day 8', 'description': 'Apparent terminal elimination rate constant, determined by linear regression using the terminal log linear phase of the log transformed concentration versus time curve.'}, {'measure': 'Apparent Terminal Elimination Half-life (t1/2term) of ALS-008112 (JNJ-63549109)', 'timeFrame': 'Up to Day 8', 'description': 'The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration time curve and calculated as 0.693/apparent terminal elimination rate constant (lambda\\[z\\]).'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of ALS-008144 (JNJ-64167896)', 'timeFrame': 'Up to Day 8', 'description': 'Cmax is the maximum observed plasma concentration.'}, {'measure': 'Time to Reach Maximum Concentration (Tmax) of ALS-008144 (JNJ-64167896)', 'timeFrame': 'Up to Day 8', 'description': 'Tmax defined as the actual sampling time to reach the maximum observed plasma concentration.'}, {'measure': 'Area Under Plasma Concentration Curve from time zero to the last quantifiable (AUC [0-last]) of ALS-008144 (JNJ-64167896)', 'timeFrame': 'Up to Day 8', 'description': 'AUC (0-last) defined as area under the plasma concentration time curve (AUC) from time 0 to the time of the last measurable (non below quantification limit \\[non-BQL\\]) concentration, calculated by linear trapezoidal summation.'}, {'measure': 'Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of ALS-008144 (JNJ-64167896)', 'timeFrame': 'Up to Day 8', 'description': 'The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time calculated as the sum of AUC (0-last) and C (0-last)/ lambda(z); wherein AUC (0-last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.'}, {'measure': 'Apparent Terminal Elimination Rate Constant (lambda z) of ALS-008144 (JNJ-64167896)', 'timeFrame': 'Up to Day 8', 'description': 'Apparent terminal elimination rate constant, determined by linear regression using the terminal log linear phase of the log transformed concentration versus time curve.'}, {'measure': 'Apparent Terminal Elimination Half-life (t1/2term) of ALS-008144 (JNJ-64167896)', 'timeFrame': 'Up to Day 8', 'description': 'The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration time curve and calculated as 0.693/apparent terminal elimination rate constant (lambda\\[z\\]).'}, {'measure': 'Number of Participants With Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': 'Screening (28 days ) to Follow up Phase (10 to 14 days after last dose)', 'description': 'Safety and Tolerability'}, {'measure': 'Taste of JNJ-64041575 following administration of different oral suspension formulations under fed and fasted conditions in healthy adult participants in Panel 1 (taste questionnaire)', 'timeFrame': 'Day 1', 'description': "Participants will complete a taste questionnaire within 5 to 15 minutes after study drug intake in each treatment period. For the taste questionnaire, a dichotomization will be made for the overall question, categorizing 'bad' and 'almost acceptable' versus 'acceptable' and 'good'."}, {'measure': 'Taste and Swallowability of JNJ-64041575 following administration of different oral tablet formulations under fed and fasted conditions in healthy adult participants in Panel 2 (taste and swallowability questionnaire)', 'timeFrame': 'Day 1', 'description': "A taste and swallowability questionnaire will be completed by the participant within 5 to 15 minutes after each study drug intake in each treatment period, to compare the taste and swallowability (tablets only) of JNJ-64041575 following administration of different oral formulations under fed and fasted conditions. For the taste questionnaire, a dichotomization will be made for the overall question, categorizing 'bad' and 'almost acceptable' versus 'acceptable' and 'good'. For the swallowability, a dichotomization will be made of 'slightly difficult' or worse versus 'neither difficult nor easy' or better. The results of the questionnaire will be transcribed into the e-Source by a member of the study-site personnel."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the rate and extent of absorption of JNJ-64041575 by measuring ALS-008112 plasma concentrations following administration of a single oral dose of JNJ-64041575 given as 2 new concept formulations (oral suspension and tablet) compared to their respective current formulations under fasted conditions and to assess the effect of food on the pharmacokinetics of the 2 new concept formulations under fed condition in healthy adult participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant must have a body mass index (BMI; weight in kg divided by the square of height in meters) between 18.0 and 30.0 kilogram per square meter kg/m\\^2, extremes included, and a body weight not less than 50.0 kg, extremes included\n* Participant must have a normal 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function at screening, including: a) normal sinus rhythm (heart rate between 45 and 100 beats per minute \\[bpm\\], extremes included); b) QT corrected according to Fridericia's formula (QTcF) interval less than or equal to (\\<=)430 milliseconds (ms) for male participants and \\<=450 ms for female participants; c) QRS interval \\<=110 ms; d) PR interval \\<=200 ms; e) ECG morphology consistent with healthy cardiac conduction and function. Any evidence of heart block, or of left or right bundle branch block is exclusionary\n* Participants must have normal values for alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (less than or equal (\\<=)1.0×upper limit of laboratory normal range \\[ULN\\])\n* Contraceptive use by female participants should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies. Before randomization, a woman must be either: a) Not of childbearing potential defined as: 1) Postmenopausal: A postmenopausal state is defined as greater than (\\>)45 years and no menses for 12 consecutive months without an alternative medical cause and a serum follicle stimulating hormone (FSH) level in the postmenopausal range (\\>40 International units per liter \\[IU/L\\] or milli-international units per milliliter \\[mIU/mL\\]), OR; 2) Permanently sterile: Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures (without reversal operation), and bilateral oophorectomy b) Of childbearing potential and, if heterosexually active, 1) Practicing a highly effective method of contraception (failure rate of less than (\\<)1percent (%) per year when used consistently and correctly) 2) Agrees to remain on a highly effective method throughout the study and for at least 44 days after the last dose of study drug\n* A female participant, except if postmenopausal, must have a negative serum beta human chorionic gonadotropin (beta- hCG) pregnancy test at screening, and a negative urine pregnancy test on Day 1 in each treatment period\n* Participant must be able to taste and smell normally, to their own opinion. Participants who have an impaired sense of taste and/or smell due to any conditions such as allergic rhinitis, common cold, or sinusitis are not eligible to take part in the study\n\nExclusion Criteria:\n\n* Participant has a mouth pathology including, but not limited to, pain, ulcer, edema, mucosal erosion, gingivitis and/or (dental) abscesses, or receives treatment for oral pathologies (eg, antifungals or antibiotics) or oral treatment for any disease\n* Participant with a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs\n* Participant is hepatitis B surface antigen (HBsAg) positive or hepatitis C virus (HCV) antibody positive with HCV RNA positive, or has another clinically active liver disease at screening\n* Participant has a history of human immunodeficiency virus type 1 (HIV-1) or HIV 2 antibody positive, or tests positive for HIV-1 or -2 at screening\n* Participant has previously been dosed with JNJ-64041575 in more than 3 single-dose studies with JNJ-64041575 or has previously been dosed with JNJ-64041575 in a multiple-dose study with JNJ-64041575\n* Participants with 1 or more of the following laboratory abnormalities at screening as defined by the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table a) Serum creatinine grade 1 or greater (greater \\[\\>\\]1.0\\* upper limit of laboratory normal range \\[ULN\\]) b) Hemoglobin grade 1 or greater (\\<=10.5 gram per decilitre \\[g/dL\\]) c) Platelet count grade 1 or greater (\\<=99.999/millimeter \\[mm\\]\\^3) d) Reticulocyte count (absolute) below the lower limit of laboratory normal range (LLN) e) Absolute neutrophil count grade 1 or greater (\\<=1,500/mm\\^3) f) Total bilirubin grade 1 or greater (\\>1.0\\*ULN) g) Any other toxicity grade 2 or above, except for grade 2 elevations of low density lipoprotein (LDL) cholesterol and/or cholesterol"}, 'identificationModule': {'nctId': 'NCT03010059', 'briefTitle': 'A Study to Assess the Relative Bioavailability of JNJ64041575 Administered as 2 Different New Concept Formulations (Oral Suspension and Tablet) Compared to Their Respective Current Formulations, and to Assess the Effect of Food on the Pharmacokinetics of the 2 New Concept Formulations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'An Open-label, Randomized, 3-way Crossover Study in Healthy Adult Subjects to Assess the Relative Bioavailability of a Single Dose of JNJ-64041575 Administered as 2 Different New Concept Formulations (Oral Suspension and Tablet) Compared to Their Respective Current Formulations, and to Assess the Effect of Food on the Pharmacokinetics of the 2 New Concept Formulations', 'orgStudyIdInfo': {'id': 'CR108251'}, 'secondaryIdInfos': [{'id': '2016-004018-86', 'type': 'EUDRACT_NUMBER'}, {'id': '64041575RSV1005', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Panel 1: Treatment ABC', 'description': 'Participants will receive 240 milligram (mg) JNJ-64041575 as 6.0 milliliter (mL) of a 40-milligram per milliliter (mg/mL) current oral suspension formulation (reference 1) under fasted conditions (Treatment A) in period 1, then 4.0 mL of a 60-mg/mL new concept oral suspension formulation (test 1) under fasted conditions (Treatment B) in period 2 followed by 4.0 mL of a 60-mg/mL new concept oral suspension formulation (test 2) under fed conditions (Treatment C) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.', 'interventionNames': ['Drug: JNJ-64041575 (oral suspension formulation)']}, {'type': 'EXPERIMENTAL', 'label': 'Panel 1: Treatment BCA', 'description': 'Participants will receive Treatment B (test 1) in period 1, then Treatment C (test 2) in period 2 followed by Treatment A (reference 1) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.', 'interventionNames': ['Drug: JNJ-64041575 (oral suspension formulation)']}, {'type': 'EXPERIMENTAL', 'label': 'Panel 1: Treatment CAB', 'description': 'Participants will receive Treatment C (test 2) in period 1, then Treatment A (reference 1) in period 2 followed by Treatment B (test 1) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.', 'interventionNames': ['Drug: JNJ-64041575 (oral suspension formulation)']}, {'type': 'EXPERIMENTAL', 'label': 'Panel 1: Treatment ACB', 'description': 'Participants will receive Treatment A (reference 1) in period 1, then Treatment C (test 2) in period 2 followed by Treatment B (test 1) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.', 'interventionNames': ['Drug: JNJ-64041575 (oral suspension formulation)']}, {'type': 'EXPERIMENTAL', 'label': 'Panel 1: Treatment BAC', 'description': 'Participants will receive Treatment B (test 1) in period 1, then Treatment A (reference 1) in period 2 followed by Treatment C (test 2) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.', 'interventionNames': ['Drug: JNJ-64041575 (oral suspension formulation)']}, {'type': 'EXPERIMENTAL', 'label': 'Panel 1: Treatment CBA', 'description': 'Participants will receive Treatment C (test 2) in period 1, then Treatment B (test 1) in period 2 followed by Treatment A (reference 1) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.', 'interventionNames': ['Drug: JNJ-64041575 (oral suspension formulation)']}, {'type': 'EXPERIMENTAL', 'label': 'Panel 2: Treatment DEF', 'description': 'Participants will receive JNJ-64041575 as 1 tablet of the 250-mg current oral tablet formulation (reference 2) under fasted conditions (Treatment D) in period 1, then 1 tablet of the 250-mg new concept oral tablet formulation (test 3) under fasted conditions (Treatment E) in period 2 followed by 1 tablet of the 250-mg new concept oral tablet formulation (test 4) under fed conditions (Treatment F) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.', 'interventionNames': ['Drug: JNJ-64041575 (oral tablet formulation )']}, {'type': 'EXPERIMENTAL', 'label': 'Panel 2: Treatment EFD', 'description': 'Participants will receive Treatment E (test 3) in period 1, then Treatment F (test 4) in period 2 followed by Treatment D (reference 2) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.', 'interventionNames': ['Drug: JNJ-64041575 (oral tablet formulation )']}, {'type': 'EXPERIMENTAL', 'label': 'Panel 2: Treatment FDE', 'description': 'Participants will receive Treatment F (test 4) in period 1, then Treatment D (reference 2) in period 2 followed by Treatment E (test 3) then in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.', 'interventionNames': ['Drug: JNJ-64041575 (oral tablet formulation )']}, {'type': 'EXPERIMENTAL', 'label': 'Panel 2: Treatment DFE', 'description': 'Participants will receive Treatment D (reference 2) in period 1, then Treatment F (test 4) in period 2 followed by Treatment E (test 3) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.', 'interventionNames': ['Drug: JNJ-64041575 (oral tablet formulation )']}, {'type': 'EXPERIMENTAL', 'label': 'Panel 2: Treatment EDF', 'description': 'Participants will receive Treatment E (test 3) in period 1, then Treatment D (reference 2) in period 2 followed by Treatment F (test 4) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.', 'interventionNames': ['Drug: JNJ-64041575 (oral tablet formulation )']}, {'type': 'EXPERIMENTAL', 'label': 'Panel 2: Treatment FED', 'description': 'Participants will receive Treatment F (test 4) in period 1, then Treatment E (test 3) in period 2 followed by Treatment D (reference 2) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.', 'interventionNames': ['Drug: JNJ-64041575 (oral tablet formulation )']}], 'interventions': [{'name': 'JNJ-64041575 (oral suspension formulation)', 'type': 'DRUG', 'otherNames': ['ALS-008176'], 'description': 'Participants will receive 240 mg JNJ-64041575 under fasted and fed conditions in Panel 1 as current/new concept oral suspension formulation.', 'armGroupLabels': ['Panel 1: Treatment ABC', 'Panel 1: Treatment ACB', 'Panel 1: Treatment BAC', 'Panel 1: Treatment BCA', 'Panel 1: Treatment CAB', 'Panel 1: Treatment CBA']}, {'name': 'JNJ-64041575 (oral tablet formulation )', 'type': 'DRUG', 'otherNames': ['ALS-008176'], 'description': 'Participants will receive 250 mg JNJ-64041575 under fasted and fed conditions in Panel 2 as current/new concept oral tablet formulation.', 'armGroupLabels': ['Panel 2: Treatment DEF', 'Panel 2: Treatment DFE', 'Panel 2: Treatment EDF', 'Panel 2: Treatment EFD', 'Panel 2: Treatment FDE', 'Panel 2: Treatment FED']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2170', 'city': 'Merksem', 'country': 'Belgium', 'facility': 'Clinical Pharmacology Unit', 'geoPoint': {'lat': 51.24623, 'lon': 4.44903}}], 'overallOfficials': [{'name': 'Janssen Research & Development, LLC Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Research & Development, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}